Maternal Death, Maternal Morbidity, Neonatal Death, Stillbirth
Conditions
Keywords
Maternal Health, Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Mortality, Quality Improvement, Resource Limited Settings, Checklist, Safe Childbirth
Brief summary
The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in north India.
Detailed description
The WHO Safe Childbirth Checklist Program is a quality improvement program designed to support health workers to deliver evidence-based practices to women and newborns around the time of institutional childbirths. At the program's core is the Safe Childbirth Checklist, a 31-item list of essential practices that target the major causes of maternal and newborn mortality in low-resource settings globally. The program was developed over 3 years by a partnership of WHO and HSPH, working with a large international network of experts and stakeholders in maternal, fetal, and newborn health. Pilot testing of the program at a public-sector birth center in south India demonstrated dramatic improvements in health worker adherence to essential childbirth-related clinical care standards. The current study is a matched-pair, cluster randomized trial to measure the efficacy of the program in reducing severe maternal and newborn harm. This trial will be conducted at approximately 120 health facilities in Uttar Pradesh, India.
Interventions
BEHAVIORALWHO Safe Childbirth Checklist Program
The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.
Sponsors
World Health Organization
Population Services International
Jawaharlal Nehru Medical College
Community Empowerment Lab
Brigham and Women's Hospital
Bill and Melinda Gates Foundation
MacArthur Foundation
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* For measuring outcomes, inclusion criteria are all mothers admitted to a study site for childbirth and newborn babies who are to be followed-up. In case a mother or baby from an enrolled site is referred out to another facility (before or after delivery) the mother-baby dyad will be included in the study and the outcome will be allocated to the referring facility * For a smaller subset of birth events (approximately 4,650 deliveries total), health worker practices will be observed to measure the impact of the SCC program on delivery of essential practices, as a secondary outcome. A convenience sample of women who agree to observation and their babies cared for by the health workers around the time of childbirth at the facility during data collectors' duty hours will be included in this component of the study.
Exclusion criteria
* Mothers who have been referred into the facility by an inter-facility transfer. * Mothers being managed for abortion. * Mothers who refuse consent for follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days | 0-7 days after delivery | The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Perinatal Death Within 7 Days | 0-7 days | Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death) |
| Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days | 0-7 days after delivery | Percentage of participants with composite rate of perinatal death and maternal death within 7 days |
| Count of Participants With Stillbirth | 0-7 days after delivery | Newborn outcome; rate of stillbirth |
| Count of Participants With Early Neonatal Death | 0-7 days after delivery | Newborn outcome; rate of early neonatal death |
| Count of Participants With Maternal Death | 0-7 days after delivery | Maternal outcome; rate of maternal death |
| Count of Participants With Severe Maternal Complications | 0-7 days after delivery | Maternal outcome; any severe maternal complication within 7 days |
| Count of Participants With Cesarean Section | Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary) | Rate of cesarean section |
| Count of Participants With Maternal Referral, Before or After Delivery | 0-7 days after delivery | Maternal outcome; Rate of maternal inter-facility transfer |
| Count of Participants With Newborn Referral | 0-7 days after delivery | Newborn outcome; Newborn referral |
| Count of Participants With Hysterectomy Within 7 Days | 0-7 days after delivery | Rate of hysterectomy within 7 days |
| Count of Participants With Blood Transfusion Within 7 Days | 0-7 days after delivery | Rate of blood transfusion within 7 days |
| Count of Mothers Returning to Facility for a Health Problem Within 7 Days | 0-7 days after delivery | Maternal Outcome; Rate of need for follow-up care for Mother |
| Count of Newborns Returning to Facility for a Health Problem Within 7 Days | 0-7 days after delivery | Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | 2 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start. |
| Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | 2 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start. |
| Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | 2 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start. |
| Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | 2 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start. |
| Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start | 12 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start. |
| Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | 12 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start. |
| Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | 12 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | 12 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | 12 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start |
| Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | 12 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start. |
| Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | 2 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start. |
| Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start | 2 months post-intervention start | Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start. |
Countries
India
Participant flow
Pre-assignment details
320 facilities were assessed for eligibility. 200 were excluded (37 did not meet inclusion criteria, 163 did not have a matching facility identified). A total of 163,939 women were screened for eligibility; of those, 161,107 women were eligible for participation, and 157,689 women consented and were enrolled into the trial.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Health Facility Participants Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.
Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.
WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection. | 81 |
| Intervention Health Facility Participants Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.
Intervention Health Facilities received the WHO Safe Childbirth Checklist Program.
WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection. | 60 |
| Control Health Facility Participants Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.
Matched control facilities provided comparison for intervention facilities. | 79 |
| Control Health Facility Participants Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent.
Matched control facilities provided comparison for intervention facilities. | 60 |
| Total | 280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Assessing Eligibility and Consent | Did not consent or declined follow-up | 1,862 | 1,556 |
| Assessing Eligibility and Consent | Were not eligible for inclusion | 1,241 | 1,591 |
| Follow-Up | Lost to Follow-up | 219 | 231 |
| Follow-Up | Withdrawal by Subject | 46 | 48 |
Baseline characteristics
| Characteristic | Control Health Facility Participants | Total | Intervention Health Facility Participants |
|---|---|---|---|
| Age, Continuous | 25.7 years | 25.66 years | 25.6 years |
| Cluster Size | 1320 participants per site | 1343 participants per site | 1365 participants per site |
| Functional Classification Community Health Center | 29 Facilities | 56 Facilities | 27 Facilities |
| Functional Classification First referral unit | 8 Facilities | 18 Facilities | 10 Facilities |
| Functional Classification Primary health center | 23 Facilities | 46 Facilities | 23 Facilities |
| Low birth weight | 22728 Participants | 45044 Participants | 22316 Participants |
| Mean Annual Delivery Load | 1683 deliveries | 1641 deliveries | 1599 deliveries |
| Mean distance to district hospital | 30.3 km | 29.9 km | 29.5 km |
| Mean previous pregnancies | 2.3 previous pregnancies | 2.36 previous pregnancies | 2.4 previous pregnancies |
| Mean skilled birth attendants per facility | 4.4 number of skilled birth attendants | 4.4 number of skilled birth attendants | 4.4 number of skilled birth attendants |
| Minutes between admission and delivery | 206 minutes | 203 minutes | 200 minutes |
| No. of offspring Sets of triplets | 5 Participants | 10 Participants | 5 Participants |
| No. of offspring Sets of twins | 533 Participants | 1048 Participants | 515 Participants |
| No. of offspring Singleton | 77582 Participants | 157984 Participants | 80402 Participants |
| No. of offspring Unknown | 1,062 Participants | 2065 Participants | 1,003 Participants |
| Preterm birth | 17703 Participants | 33644 Participants | 15941 Participants |
| Providers attending delivery Auxiliary nurse midwife | 14549 Participants | 29860 Participants | 15311 Participants |
| Providers attending delivery Doctor | 11599 Participants | 22714 Participants | 11115 Participants |
| Providers attending delivery Nurse | 64117 Participants | 130804 Participants | 66687 Participants |
| Providers attending delivery Others | 6560 Participants | 9193 Participants | 2633 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment India | 79182 participants | 161107 participants | 81925 participants |
| Sex: Female, Male Female | 79182 Participants | 161107 Participants | 81925 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Sex of newborn Female | 36266 Participants | 73242 Participants | 36976 Participants |
| Sex/Gender, Customized Sex of newborn Male | 39063 Participants | 79621 Participants | 40558 Participants |
| Sex/Gender, Customized Sex of newborn Unknown | 3334 Participants | 7247 Participants | 3913 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3,917 / 159,587 | 3,677 / 154,684 |
| other Total, other adverse events | 0 / 159,587 | 0 / 154,684 |
| serious Total, serious adverse events | 0 / 159,587 | 0 / 154,684 |
Outcome results
Primary
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke.
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about their death, their baby(s) and their morbidity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Health Facility Participants | Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days | 15.1 percentage of women/newborn dyads |
| Control Health Facility Participants | Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days | 15.3 percentage of women/newborn dyads |
p-value: 0.995% CI: [0.83, 1.18]Chi-squared, Corrected
Secondary
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
Maternal Outcome; Rate of need for follow-up care for Mother
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about returning to a health facility for a health problem within 7 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Mothers Returning to Facility for a Health Problem Within 7 Days | 2014 Participants |
| Control Health Facility Participants | Count of Mothers Returning to Facility for a Health Problem Within 7 Days | 2141 Participants |
p-value: 0.3295% CI: [0.76, 1.1]Chi-squared, Corrected
Secondary
Count of Newborns Returning to Facility for a Health Problem Within 7 Days
Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins)
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about status of at least one baby returning to the facility for a health problem within 7 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Newborns Returning to Facility for a Health Problem Within 7 Days | 4474 Participants |
| Control Health Facility Participants | Count of Newborns Returning to Facility for a Health Problem Within 7 Days | 4722 Participants |
p-value: 0.395% CI: [0.78, 1.08]Chi-squared, Corrected
Secondary
Count of Participants With Blood Transfusion Within 7 Days
Rate of blood transfusion within 7 days
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about their status regarding blood transfusion within 7 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Blood Transfusion Within 7 Days | 640 Participants |
| Control Health Facility Participants | Count of Participants With Blood Transfusion Within 7 Days | 625 Participants |
p-value: 0.9795% CI: [0.69, 1.43]Chi-squared, Corrected
Secondary
Count of Participants With Cesarean Section
Rate of cesarean section
Time frame: Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
Population: The denominator for this analysis is all women who had non-missing information about whether they had a cesarean section.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Cesarean Section | 1469 Participants |
| Control Health Facility Participants | Count of Participants With Cesarean Section | 1330 Participants |
p-value: 0.7495% CI: [0.72, 1.58]Chi-squared, Corrected
Secondary
Count of Participants With Early Neonatal Death
Newborn outcome; rate of early neonatal death
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced neonatal death.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Early Neonatal Death | 2409 Participants |
| Control Health Facility Participants | Count of Participants With Early Neonatal Death | 2119 Participants |
p-value: 0.1995% CI: [0.95, 1.27]Chi-squared, Corrected
Secondary
Count of Participants With Hysterectomy Within 7 Days
Rate of hysterectomy within 7 days
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about their hysterectomy status within 7 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Hysterectomy Within 7 Days | 19 Participants |
| Control Health Facility Participants | Count of Participants With Hysterectomy Within 7 Days | 18 Participants |
p-value: 0.9595% CI: [0.45, 2.13]Chi-squared, Corrected
Secondary
Count of Participants With Maternal Death
Maternal outcome; rate of maternal death
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about maternal death status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Maternal Death | 78 Participants |
| Control Health Facility Participants | Count of Participants With Maternal Death | 71 Participants |
p-value: 0.7395% CI: [0.74, 1.53]Chi-squared, Corrected
Secondary
Count of Participants With Maternal Referral, Before or After Delivery
Maternal outcome; Rate of maternal inter-facility transfer
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about their status regarding referral before and after delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Maternal Referral, Before or After Delivery | 5381 Participants |
| Control Health Facility Participants | Count of Participants With Maternal Referral, Before or After Delivery | 4779 Participants |
p-value: 0.5795% CI: [0.81, 1.47]Chi-squared, Corrected
Secondary
Count of Participants With Newborn Referral
Newborn outcome; Newborn referral
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about their newborn(s) referral status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Newborn Referral | 1455 Participants |
| Control Health Facility Participants | Count of Participants With Newborn Referral | 1186 Participants |
p-value: 0.4195% CI: [0.78, 1.8]Chi-squared, Corrected
Secondary
Count of Participants With Perinatal Death Within 7 Days
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Time frame: 0-7 days
Population: There is a discrepancy between the denominator of each primary and secondary outcome because there were a different number of newborns than mothers in the trial. Additionally, we do not have data on every participant for every question. As such, the denominator is specific for each outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Perinatal Death Within 7 Days | 3839 Participants |
| Control Health Facility Participants | Count of Participants With Perinatal Death Within 7 Days | 3606 Participants |
p-value: 0.6895% CI: [0.89, 1.2]Chi-squared, Corrected
Secondary
Count of Participants With Severe Maternal Complications
Maternal outcome; any severe maternal complication within 7 days
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about each morbidity. Not every respondent answered each question, so each row has a different denominator. Only women who answered all specific morbidity questions were incorporated into the participant count for any maternal severe complication within 7 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Severe Maternal Complications | Any maternal severe complication within 7 days | 9086 Participants |
| Intervention Health Facility Participants | Count of Participants With Severe Maternal Complications | Seizures | 67 Participants |
| Intervention Health Facility Participants | Count of Participants With Severe Maternal Complications | Loss of consciousness for >1 hour | 505 Participants |
| Intervention Health Facility Participants | Count of Participants With Severe Maternal Complications | High fever with foul-smelling vaginal discharge | 4073 Participants |
| Intervention Health Facility Participants | Count of Participants With Severe Maternal Complications | Hemorrhage | 5745 Participants |
| Intervention Health Facility Participants | Count of Participants With Severe Maternal Complications | Stroke | 9 Participants |
| Control Health Facility Participants | Count of Participants With Severe Maternal Complications | Hemorrhage | 5875 Participants |
| Control Health Facility Participants | Count of Participants With Severe Maternal Complications | Any maternal severe complication within 7 days | 9037 Participants |
| Control Health Facility Participants | Count of Participants With Severe Maternal Complications | High fever with foul-smelling vaginal discharge | 3871 Participants |
| Control Health Facility Participants | Count of Participants With Severe Maternal Complications | Seizures | 70 Participants |
| Control Health Facility Participants | Count of Participants With Severe Maternal Complications | Stroke | 12 Participants |
| Control Health Facility Participants | Count of Participants With Severe Maternal Complications | Loss of consciousness for >1 hour | 493 Participants |
Comparison: Rate any severe maternal complication within 7 daysp-value: 0.8195% CI: [0.79, 1.2]Chi-squared, Corrected
Comparison: Rate of seizuresp-value: 0.7695% CI: [0.57, 1.52]Chi-squared, Corrected
Comparison: Rate of loss of consciousness for \> 1 hrp-value: 0.9795% CI: [0.7, 1.41]Chi-squared, Corrected
Comparison: Rate of high fever with foul-smelling vaginal dischargep-value: 0.995% CI: [0.76, 1.38]Chi-squared, Corrected
Comparison: Rate of hemorrhagep-value: 0.6195% CI: [0.77, 1.17]Chi-squared, Corrected
Comparison: Rate of strokep-value: 0.4195% CI: [0.34, 1.58]Chi-squared, Corrected
Secondary
Count of Participants With Stillbirth
Newborn outcome; rate of stillbirth
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced stillbirth.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Health Facility Participants | Count of Participants With Stillbirth | 1513 Participants |
| Control Health Facility Participants | Count of Participants With Stillbirth | 1559 Participants |
p-value: 0.5695% CI: [0.76, 1.16]Chi-squared, Corrected
Secondary
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
Percentage of participants with composite rate of perinatal death and maternal death within 7 days
Time frame: 0-7 days after delivery
Population: The denominator for this analysis is all women who had non-missing information about their death, and their baby(s)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Health Facility Participants | Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days | 4.9 percentage of women and newborns |
| Control Health Facility Participants | Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days | 4.7 percentage of women and newborns |
p-value: 0.6795% CI: [0.89, 1.2]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start.
Time frame: 12 months post-intervention start
Population: The denominator for this analysis is all women who were observed at admission, 12 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Maternal blood pressure taken | 219 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Partography started | 7 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Maternal temperature taken | 153 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Checklist use | 175 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Birth companion present | 1004 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Checklist use | 0 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Birth companion present | 1006 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Maternal blood pressure taken | 11 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Maternal temperature taken | 0 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start | Partography started | 0 Participants |
Comparison: Birth companion presentp-value: 195% CI: [1, 1]Chi-squared, Corrected
Comparison: Maternal blood pressure takenp-value: <0.00195% CI: [7.9, 46.5]Chi-squared, Corrected
Comparison: Maternal temperature takenp-value: <0.001Chi-squared, Corrected
Comparison: Partography startedp-value: <0.001Chi-squared, Corrected
Comparison: Checklist usep-value: <0.001Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start.
Time frame: 2 months post-intervention start
Population: The denominator for this analysis is all women who were observed at admission, 2 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Maternal blood pressure taken | 606 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Partography started | 10 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Maternal temperature taken | 569 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Checklist use | 595 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Birth companion present | 1048 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Checklist use | 1 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Birth companion present | 1087 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Maternal blood pressure taken | 64 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Maternal temperature taken | 4 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start | Partography started | 1 Participants |
Comparison: Birth Companion Presentp-value: 0.18Chi-squared, Corrected
Comparison: Maternal blood pressure takenp-value: <0.00195% CI: [3.4, 28.3]Chi-squared, Corrected
Comparison: Maternal temperature takenp-value: <0.00195% CI: [26.9, 645]Chi-squared, Corrected
Comparison: Partography startedp-value: 0.0195% CI: [1.5, 35.6]Chi-squared, Corrected
Comparison: Checklist usep-value: <0.00195% CI: [65.8, 2589]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start.
Time frame: 12 months post-intervention start
Population: The denominator for this analysis is all women who were observed at anytime, 12 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Maternal temperature taken | 343 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Maternal blood pressure taken | 425 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Mother given magnesium sulfate | 1 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Maternal temperature taken | 0 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Maternal blood pressure taken | 35 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start | Mother given magnesium sulfate | 1 Participants |
Comparison: Maternal temperature takenp-value: <0.001Chi-squared, Corrected
Comparison: Maternal blood pressure takenp-value: <0.00195% CI: [4.7, 34.3]Chi-squared, Corrected
Comparison: Mother given magnesium sulfatep-value: 0.9595% CI: [0.2, 6.6]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start.
Time frame: 2 months post-intervention start
Population: The denominator for this analysis is all women who were observed at any time during delivery, 2 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Maternal temperature taken | 792 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Maternal blood pressure taken | 854 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Mother given magnesium sulfate | 1 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Maternal temperature taken | 4 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Maternal blood pressure taken | 89 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start | Mother given magnesium sulfate | 3 Participants |
Comparison: Maternal temperature takenp-value: <0.00195% CI: [33.5, 993]Chi-squared, Corrected
Comparison: Maternal blood pressure takenp-value: <0.00195% CI: [3.8, 25.8]Chi-squared, Corrected
Comparison: Mother given magnesium sulfatep-value: 0.395% CI: [0.1, 2.1]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start
Time frame: 12 months post-intervention start
Population: The denominator for this analysis is all women who were observed at the time just before pushing, 12 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | No oxytocin given before delivery | 527 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Mucus extractor available | 999 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Clean scissors or blade available | 1004 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Neonatal bag and mask available | 1017 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Clean towel available | 721 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Pads available | 768 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Cord tie available | 1009 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Checklist Use | 55 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Hand hygiene | 126 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Checklist Use | 1 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Hand hygiene | 6 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | No oxytocin given before delivery | 263 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Clean towel available | 314 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Clean scissors or blade available | 1008 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Cord tie available | 1039 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Mucus extractor available | 1000 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Neonatal bag and mask available | 1036 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start | Pads available | 559 Participants |
Comparison: Hand hygienep-value: <0.00195% CI: [6.6, 60.4]Chi-squared, Corrected
Comparison: No oxytocin given before deliveryp-value: 0.0495% CI: [1, 4.1]Chi-squared, Corrected
Comparison: Clean towel availablep-value: 0.00695% CI: [1.3, 4.3]Chi-squared, Corrected
Comparison: Clean scissors or blade availablep-value: 0.3495% CI: [1, 1.1]Chi-squared, Corrected
Comparison: Cord tie availablep-value: 0.2595% CI: [1, 1]Chi-squared, Corrected
Comparison: Mucus extractor availablep-value: 0.595% CI: [1, 1.1]Chi-squared, Corrected
Comparison: Neonatal bag and mask availablep-value: 0.3295% CI: [1, 1]Chi-squared, Corrected
Comparison: Pads availablep-value: 0.1195% CI: [0.9, 2.1]Chi-squared, Corrected
Comparison: Checklist availablep-value: <0.00195% CI: [7.3, 196]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start.
Time frame: 2 months post-intervention start
Population: The denominator for this analysis is all women who were observed at the time of labor just before pushing, 2 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | No oxytocin given before delivery | 704 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Mucus extractor available | 990 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Clean scissors or blade available | 843 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Neonatal bag and mask available | 991 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Clean towel available | 874 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Pads available | 965 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Cord tie available | 1035 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Checklist Use | 255 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Hand hygiene | 367 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Checklist Use | 1 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Hand hygiene | 7 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | No oxytocin given before delivery | 333 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Clean towel available | 166 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Clean scissors or blade available | 847 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Cord tie available | 1122 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Mucus extractor available | 1057 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Neonatal bag and mask available | 1109 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start | Pads available | 502 Participants |
Comparison: Hand hygienep-value: <0.00195% CI: [13.1, 217]Chi-squared, Corrected
Comparison: No oxytocin given before deliveryp-value: 0.00795% CI: [1.3, 4.2]Chi-squared, Corrected
Comparison: Clean towel availablep-value: <0.00195% CI: [2.7, 12.1]Chi-squared, Corrected
Comparison: Clean scissors or blade availablep-value: 0.7295% CI: [0.7, 1.7]Chi-squared, Corrected
Comparison: Cord tie availablep-value: 0.4895% CI: [1, 1]Chi-squared, Corrected
Comparison: Mucus extractor availablep-value: 0.7395% CI: [0.9, 1.1]Chi-squared, Corrected
Comparison: Neonatal bag and mask availablep-value: 0.5695% CI: [0.9, 1.1]Chi-squared, Corrected
Comparison: Pads availablep-value: 0.00595% CI: [1.3, 3.5]Chi-squared, Corrected
Comparison: Checklist usep-value: <0.00195% CI: [19.7, 1738]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start
Time frame: 12 months post-intervention start
Population: The denominator for this analysis is all women who were observed within one hour after delivery, 12 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Newborn weight taken | 947 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Newborn temperature taken | 225 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Skin-to-skin care initiated at birth | 685 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Skin-to-skin care maintained for 1 hr | 51 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Initiation of breast-feeding | 369 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Checklist use | 351 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Initiation of breast-feeding | 47 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Newborn weight taken | 843 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Skin-to-skin care maintained for 1 hr | 0 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Newborn temperature taken | 2 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Checklist use | 0 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start | Skin-to-skin care initiated at birth | 84 Participants |
Comparison: Newborn weight takenp-value: 0.0895% CI: [1, 1.3]Chi-squared, Corrected
Comparison: Newborn temperature takenp-value: <0.00195% CI: [11, 758]Chi-squared, Corrected
Comparison: Skin-to-skin care initiated at birthp-value: <0.00195% CI: [2.5, 27.5]Chi-squared, Corrected
Comparison: Skin-to-skin care maintained for 1 hrp-value: 0.01Chi-squared, Corrected
Comparison: Initiation of breast-feedingp-value: <0.00195% CI: [3.7, 16.7]Chi-squared, Corrected
Comparison: Checklist usep-value: <0.001Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start.
Time frame: 2 months post-intervention start
Population: The denominator for this analysis is all women who were observed at one hour after delivery, 2 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Newborn weight taken | 906 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Newborn temperature taken | 433 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Skin-to-skin care initiated at birth | 794 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Skin-to-skin care maintained for 1 hr | 194 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Initiation of breast-feeding | 700 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Checklist use | 747 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Initiation of breast-feeding | 39 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Newborn weight taken | 884 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Skin-to-skin care maintained for 1 hr | 5 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Newborn temperature taken | 1 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Checklist use | 0 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start | Skin-to-skin care initiated at birth | 119 Participants |
Comparison: Newborn weight takenp-value: 0.2595% CI: [0.9, 1.4]Chi-squared, Corrected
Comparison: Newborn temperature takenp-value: <0.00195% CI: [50.4, 1989]Chi-squared, Corrected
Comparison: Skin-to-skin care initiated at birthp-value: <0.00195% CI: [2.4, 22]Chi-squared, Corrected
Comparison: Skin-to-skin care maintained for 1 hrp-value: <0.00195% CI: [7.7, 194]Chi-squared, Corrected
Comparison: Initiation of breast-feedingp-value: <0.00195% CI: [11.4, 33.2]Chi-squared, Corrected
Comparison: Checklist usep-value: <0.001Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start
Time frame: 12 months post-intervention start
Population: The denominator for this analysis is all women who were observed within one minute after delivery, 12 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Oxytocin Administered | 549 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Neonatal bag used | 30 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Birth companion present | 1016 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Oxytocin Administered | 154 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Neonatal bag used | 49 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start | Birth companion present | 1035 Participants |
Comparison: Oxytocin administeredp-value: <0.00195% CI: [1.8, 7.5]Chi-squared, Corrected
Comparison: Neonatal bag usedp-value: 0.1995% CI: [0.3, 1.3]Chi-squared, Corrected
Comparison: Birth companion presentp-value: 0.595% CI: [1, 1]Chi-squared, Corrected
Other Pre-specified
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start.
Time frame: 2 months post-intervention start
Population: The denominator for this analysis is all women who were observed within one minute after delivery, 2 months post-intervention start in the site.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Oxytocin Administered | 825 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Neonatal bag used | 47 Participants |
| Intervention Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Birth companion present | 1037 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Oxytocin Administered | 231 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Neonatal bag used | 82 Participants |
| Control Health Facility Participants | Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start | Birth companion present | 1125 Participants |
Comparison: Oxytocin administeredp-value: <0.00195% CI: [2.1, 7.2]Chi-squared, Corrected
Comparison: Neonatal bag usedp-value: 0.2595% CI: [0.3, 1.4]Chi-squared, Corrected
Comparison: Birth attendant presentp-value: 0.2595% CI: [1, 1]Chi-squared, Corrected
Other Pre-specified
Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start.
Time frame: 12 months post-intervention start
Population: The denominator for this analysis is all women who were observed for at least one pause point 12 months post-intervention start in the site.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Health Facility Participants | Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start | 11.1 essential birth practices performed |
| Control Health Facility Participants | Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start | 7.9 essential birth practices performed |
p-value: <0.001Chi-squared, Corrected
Other Pre-specified
Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start.
Time frame: 2 months post-intervention start
Population: The denominator for this analysis is all women who were observed for at least one pause point 2 months post-intervention start in the site.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Health Facility Participants | Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start | 13.1 essential birth practices performed |
| Control Health Facility Participants | Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start | 7.5 essential birth practices performed |
p-value: <0.001Chi-squared, Corrected