Antenatal Care
Conditions
Keywords
Antenatal care, Sub-Saharan Africa, Ghana
Brief summary
Antenatal care (ANC) has the potential to play a pivotal role in ensuring positive pregnancy outcomes for both mothers and their newborns. A critical component of all ANC is teaching women to recognize the major complications that account for the majority of preventable maternal and newborn deaths. Antenatal care provides an opportunity to promote a healthy lifestyle, to integrate positive health behaviors, and to develop a trusting relationship with a provider and the health system. While group ANC has been delivered and studied in high-resource settings for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. The goal of this research is to improve health literacy and reduce preventable maternal and newborn morbidities and mortality within highly vulnerable, low and non-literate populations that assume a disproportionate burden of poor pregnancy outcomes globally. This research examines a bold, new approach to ANC that takes provision of care out of clinic exam rooms into small groups of women grouped by gestational age in low resource settings with low and non-literate populations. Group ANC has the potential to shift the current clinical practice paradigm of antenatal care for highly vulnerable women to improve maternal and newborn outcomes both globally and domestically. The investigators hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1) increased birth preparedness and complication readiness (BPCR), including recognition of danger signs and knowledge of how to respond to such signs; 2) higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal and postpartum care; and 3) better clinical outcomes for themselves and their newborns than women who received the routine, individual ANC.
Detailed description
We are at a critical time to examine new, innovative strategies to promote healthy pregnancy and optimize maternal and newborn outcomes. Generating successful strategies will require careful examination of existing service delivery models, challenging the current structure of care provision. One aspect of care, recently identified by the World Health Organization, which merits further research, is group antenatal care (ANC). Since ANC is widely available and attended by the majority of pregnant women in Ghana without the expected impact on birth outcomes, it is vital to examine the way antenatal health messages are delivered. Pregnant women must receive health information that is accurate and easy to understand for them to make informed choices to improve their health and the health of their baby. A critical component of all ANC is teaching women to recognize the major complications that account for the majority of preventable maternal and newborn deaths. Antenatal care provides an opportunity to promote a healthy lifestyle, to integrate positive health behaviors, and to develop a trusting relationship with a provider and the health system. Interactions during ANC provide the opportunity to identify and treat numerous problems, as well as providing a setting to improve women's health literacy. Patients must receive health messages in a manner that allows them to process and evaluate the information and ultimately use it to impact their own health. The effectiveness of ANC depends on the multidimensional concept of health literacy. Initially considered only as a patient's ability to read and understand written information, it is now more broadly defined as a person's ability to acquire or access information, understand it, and use the information in ways that promote and maintain good health. Despite a burgeoning emphasis on health literacy in high resource countries, there are a dearth of studies examining interventions to improve health literacy in low-resource settings. Even fewer studies have examined maternal health literacy, defined as the cognitive and social skills which determine the motivation and ability of women to gain access to, understand, and use information in ways that promote and maintain their health and that of their children''. New approaches to improve health literacy are sorely needed in countries where women and newborns continue to die from preventable causes. Antenatal care has been delivered the same way for decades. Clinics and hospitals in low-resource countries are notorious for providing ethnocentric care, privileging northern medical values at the expense of traditional and community values. Yet health literacy is affected by the cultural context in which learning takes place, including, but not limited to, belief systems, traditions, understanding, and communication styles. Transmitting health information in a clinical setting often fails to take into account the social and economic circumstances of patients, therefore not achieving the expected impact on health behaviors. This divide has contributed to a lack of progress in reaching the most vulnerable populations. If pregnant women do not receive health messages in a comprehensible way, they cannot effectively maximize the benefits of the health system. Substantially improving women's ability to understand and utilize health information is of utmost importance if we are to reach the global targets of 70 maternal deaths per 100,000 live births by 2030 and a neonatal mortality rate of 12 per 1000 live births set by WHO/USAID. The investigators hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1. Increased BPCR, including recognition of danger signs and knowledge of how to respond to such signs 2. Higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal and postpartum care 3. Better clinical outcomes for themselves and their newborns than women who received the routine, individual ANC. The intervention consists of nine meetings; one individual meeting and eight group meetings. At the initial ANC visit, women are assigned to a small groups with up to14 women of similar gestational age. Women meet individually with the midwife and the standard history and physical exam as well as lab tests are completed; group visits start at the second ANC visit. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. The midwife, health facility staff member, and patients then sit in circle facing one another for a 60-90 minute facilitated discussion. The health facility staff member will assist the midwife with group activities. The model uses strategies such as story-telling, peer support, and demonstration and teach-back to enhance its effectiveness. Health literacy is incorporated as an integral part of clinical practice within the model - not as an add-on to care.
Interventions
BEHAVIORALGroup ANC
Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.
Sponsors
Dodowa Health Research Centre
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* willingness to participate in the study * less than 20 weeks' gestation 3) able to speak Dangme, Ga, Akan, Ewe, or English * over the age of 15 years
Exclusion criteria
* No history of medical problems that would indicate the participant might be considered high risk (e.g., hypertension, insulin-dependent diabetes mellitus) and thus requiring a more individualized approach to care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ability to Identify Danger Signs in Pregnancy | T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Ability to identify danger signs in pregnancy will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur during pregnancy (e.g. headache, vision changes, fever, vaginal bleeding, swollen face, etc.). There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR). The measure used in this study is an open-end question: What are the danger signs during pregnancy? Things that might mean there is a problem with you or the baby. Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome. |
| Change in Birth Preparedness and Complication Readiness | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Change in the ability to identify a strategy for birth preparedness and complication readiness (BPCR) will be measured using a binary response (yes/no) to a question that ask participants if they have: (1) saved money, (2) identified birth facility for delivery, (3) identified emergency transportation to the facility, and (4) identified a blood donor. There is no validated or standardized instrument to measure BPCR. The measure used in this study is an open-end question: What are some things a woman can do to prepare for birth? Eleven possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 11. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome. |
| Change in Ability to Identify Newborn Danger Signs | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Ability to identify newborn danger signs will be measured utilizing a self-report, open ended, question that asks participants to identify newborn danger signs that may occur after delivery (e.g. poor suck, jaundice, difficulty/fast breathing, and convulsions). Change will be measured by calculating the difference in the mean at T0 and T1. There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR). The measure used in this study is an open-end question: What are the danger signs for your newborn? Things that might mean there is a problem. Thirteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 13. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome. |
| Attendance of ANC Visits | T2 (6-12 weeks after delivery) | Attendance of 4 or more ANC visits will be gleaned from data reported on the participant's ANC/health card. |
| Place of Delivery | T2 (6-12 weeks after delivery) | Place of delivery will be measured using a self-report question (facility delivery, home delivery). |
| Attendance at Postpartum Check-ups for Mother | T2 (6-12 weeks after delivery) | Attendance of postpartum check-ups will be gleaned from information on the participant's ANC/health card. |
| Attendance at Postnatal Check-up for Newborn | T2 (6-12 weeks after delivery) | Attendance of postnatal checkup will be gleaned from information on the participant's ANC/health card using a measure of 3 visits before 6 weeks for newborns. |
| Birth Outcome | T2 (6-12 weeks after delivery) | Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality. |
| Change in Health Literacy | T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery) | Change in Health Literacy will be measured using the Maternal Health Literacy Scale. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 to T2. Maternal Health Literacy (MaHeLi) scale is a validated measure that consists of 12 yes-or-no questions to assess maternal health literacy among the participants. Raw item scores are a sum of individual responses; scores range from 0 to 12. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Newborn Weight | T2 (6-12 weeks postpartum) | Newborn weight in grams; these data will be retrieved from the participant's ANC/health card and measured as newborn weight. |
| Change in Ability to Identify Postpartum Danger Signs for Mother | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Ability to identify danger signs after delivery will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur after delivery (e.g. increased bleeding or large clots; weakness/fainting; fever; pain in abdominal or breast; painful urination, etc.). Change will be measured by calculating the difference in the mean at T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery). There is no validated or standardized instrument to measure postpartum danger signs. The measure used in this study is an open-end question: What are the danger signs for you, the mother, after the baby is born? Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome. |
| Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | T2 (6 - 12 weeks postpartum) | Mother's hemoglobin at delivery; these data will be retrieved from the participant's ANC/health card and measured as hemoglobin in grams per deciliter (g/dl). |
| Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Ability of mother to identify recommended action steps in response to danger signs that may occur before or after delivery. There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is the question: What do you think you would do if you have any of these (danger signs)? Responses are coded as Go to hospital or health facility CHECKED (1) or Go to hospital or health facility NOT CHECKED (0). Reported results are the sum of individual responses; higher score Go to hospital checked means a better outcome. |
| Change in Knowledge of Family Planning Methods | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Knowledge of family planning methods will be measured by self-report using a question that asks participants to identify all the methods of family planning they know. Change will be measured by calculating the difference in the mean at baseline and 3rd trimester. There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is an open-end question that asks participants to identify all the methods of family planning they know. Change will be measured by calculating the difference in the mean at T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery). There are eleven possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 11. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome. |
| Change in Intent to Use Family Planning | T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery) | Intent to use family planning methods will be measured by self-report using a binary (yes/no) question that asks participants, Do you intend to use family planning after delivery?. Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated yes to their intent to use family planning after delivery. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T1( 34 weeks gestation - 3 weeks postdelivery). |
| Change in Uptake of Family Planning | T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum) | Uptake of family planning will be measured by self-report using a binary (yes/no) question that asks participants if they are currently using any family planning method. Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated yes to currently using family planning. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum). |
| Change in Interpersonal Violence | T0 (baseline) and T4 (11 - 14 months postpartum) | Experiences of physical, sexual, and emotional violence were measured using an investigator-derived questionnaire that asks participants if they experienced violence in the past year, and if resources and support are available to them. Raw item scores are a sum of individual responses; scores range from 0 to 9. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T4. Higher score means higher rates of reported sexual and emotional violence and lower access to resources and support. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T4 (11 - 14 months postpartum) |
| Experience of ANC Care | T2 (6-12 postpartum) | Experience of ANC care is measured using a twenty-one item investigator-derived questionnaire that asks participants about their experience regarding respectful care, satisfaction with care, and experience such as privacy and treatment with health system during their ANC visits. Raw item scores are a sum of individual responses; scores range from 0 to 21. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome. |
| Completion of IPTp2 Malaria Prophylaxis During Pregnancy | T1 (34 weeks gestation - 3 weeks postdelivery) | Data gleaned from the participant's ANC/health record will be used to measure affirmative completion of IPTp2 malaria prophylaxis during pregnancy. |
| Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy | T1 (34 weeks gestation - 3 weeks postdelivery) | Data gleaned from the participant's ANC/health record will be used to measure if the participant received least two tetanus toxoid vaccines during pregnancy. |
Countries
Ghana
Participant flow
Recruitment details
Fourteen health facilities were randomized using a matched-pair method. Variables for matching included the number of deliveries and the average gestational age of pregnancy at the time of enrollment, so that facilities within each pair are similar to each other. For each pair of facilities, one site was randomly assigned to group ANC (intervention) and the other to routine individual ANC (control). Individual women were recruited at each health facility.
Participants by arm
| Arm | Count |
|---|---|
| Group ANC Intervention groups consist of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.
Group ANC: Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman. | 877 |
| Stand ANC Individual standard antenatal care delivered at health facilities in Ghana | 884 |
| Total | 1,761 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| T1 (34 Wks Gestation - 3 Wks Postpartum) | Death | 0 | 1 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | Lost to Follow-up | 113 | 190 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | No longer meets criteria | 30 | 19 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | Protocol Violation | 115 | 0 |
| T1 (34 Wks Gestation - 3 Wks Postpartum) | Withdrawal by Subject | 2 | 6 |
| T2 (6 - 12 Weeks Postpartum) | Death | 2 | 2 |
| T2 (6 - 12 Weeks Postpartum) | Lost to Follow-up | 133 | 247 |
| T2 (6 - 12 Weeks Postpartum) | No longer meets criteria | 1 | 10 |
| T2 (6 - 12 Weeks Postpartum) | Protocol Violation | 4 | 0 |
| T2 (6 - 12 Weeks Postpartum) | Withdrawal by Subject | 5 | 3 |
| T3 (5 - 8 Month Postpartum) | Lost to Follow-up | 96 | 165 |
| T3 (5 - 8 Month Postpartum) | Withdrawal by Subject | 3 | 5 |
| T4 (11 -14 Months Postpartum) | Lost to Follow-up | 89 | 150 |
Baseline characteristics
| Characteristic | Stand ANC | Total | Group ANC |
|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 69 Participants | 29 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 844 Participants | 1692 Participants | 848 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Ghana | 884 Participants | 1761 Participants | 877 Participants |
| Sex: Female, Male Female | 884 Participants | 1761 Participants | 877 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 877 | 3 / 884 |
| other Total, other adverse events | 0 / 877 | 0 / 884 |
| serious Total, serious adverse events | 2 / 877 | 3 / 884 |
Outcome results
Primary
Attendance at Postnatal Check-up for Newborn
Attendance of postnatal checkup will be gleaned from information on the participant's ANC/health card using a measure of 3 visits before 6 weeks for newborns.
Time frame: T2 (6-12 weeks after delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Attendance at Postnatal Check-up for Newborn | 2 day postnatal visit | 412 Participants |
| Group ANC | Attendance at Postnatal Check-up for Newborn | 6 day postnatal visit | 473 Participants |
| Group ANC | Attendance at Postnatal Check-up for Newborn | 6 week postnatal visit | 531 Participants |
| Stand ANC | Attendance at Postnatal Check-up for Newborn | 2 day postnatal visit | 460 Participants |
| Stand ANC | Attendance at Postnatal Check-up for Newborn | 6 day postnatal visit | 453 Participants |
| Stand ANC | Attendance at Postnatal Check-up for Newborn | 6 week postnatal visit | 550 Participants |
Primary
Attendance at Postpartum Check-ups for Mother
Attendance of postpartum check-ups will be gleaned from information on the participant's ANC/health card.
Time frame: T2 (6-12 weeks after delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Attendance at Postpartum Check-ups for Mother | Attended 2 day pp visit | 392 Participants |
| Group ANC | Attendance at Postpartum Check-ups for Mother | Attended 6 day pp visit | 469 Participants |
| Group ANC | Attendance at Postpartum Check-ups for Mother | Attended 6 week pp visit | 517 Participants |
| Stand ANC | Attendance at Postpartum Check-ups for Mother | Attended 2 day pp visit | 451 Participants |
| Stand ANC | Attendance at Postpartum Check-ups for Mother | Attended 6 day pp visit | 447 Participants |
| Stand ANC | Attendance at Postpartum Check-ups for Mother | Attended 6 week pp visit | 541 Participants |
Primary
Attendance of ANC Visits
Attendance of 4 or more ANC visits will be gleaned from data reported on the participant's ANC/health card.
Time frame: T2 (6-12 weeks after delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Attendance of ANC Visits | Yes | 555 Participants |
| Group ANC | Attendance of ANC Visits | No | 2 Participants |
| Stand ANC | Attendance of ANC Visits | Yes | 523 Participants |
| Stand ANC | Attendance of ANC Visits | No | 3 Participants |
Primary
Birth Outcome
Birth outcomes will be self-reported and measured as stillbirth, live birth, early neonatal mortality.
Time frame: T2 (6-12 weeks after delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Birth Outcome | Live birth | 580 Participants |
| Group ANC | Birth Outcome | Stillbirth | 5 Participants |
| Group ANC | Birth Outcome | Early neonatal mortality | 6 Participants |
| Stand ANC | Birth Outcome | Live birth | 587 Participants |
| Stand ANC | Birth Outcome | Stillbirth | 8 Participants |
| Stand ANC | Birth Outcome | Early neonatal mortality | 7 Participants |
Primary
Change in Ability to Identify Danger Signs in Pregnancy
Ability to identify danger signs in pregnancy will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur during pregnancy (e.g. headache, vision changes, fever, vaginal bleeding, swollen face, etc.). There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR). The measure used in this study is an open-end question: What are the danger signs during pregnancy? Things that might mean there is a problem with you or the baby. Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.
Time frame: T0 Baseline (at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Ability to Identify Danger Signs in Pregnancy | T0 - baseline | 1.8 units on a scale | Standard Deviation 1.3 |
| Group ANC | Change in Ability to Identify Danger Signs in Pregnancy | T1 (34 weeks gestation - 3 weeks postdelivery) | 3.4 units on a scale | Standard Deviation 1.6 |
| Stand ANC | Change in Ability to Identify Danger Signs in Pregnancy | T0 - baseline | 1.7 units on a scale | Standard Deviation 1.4 |
| Stand ANC | Change in Ability to Identify Danger Signs in Pregnancy | T1 (34 weeks gestation - 3 weeks postdelivery) | 2.2 units on a scale | Standard Deviation 1.3 |
Primary
Change in Ability to Identify Newborn Danger Signs
Ability to identify newborn danger signs will be measured utilizing a self-report, open ended, question that asks participants to identify newborn danger signs that may occur after delivery (e.g. poor suck, jaundice, difficulty/fast breathing, and convulsions). Change will be measured by calculating the difference in the mean at T0 and T1. There is no validated or standardized instrument to measure Birth Preparedness and Complication Readiness (BPCR). The measure used in this study is an open-end question: What are the danger signs for your newborn? Things that might mean there is a problem. Thirteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 13. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Ability to Identify Newborn Danger Signs | T0 Baseline at recruitment | 1.9 units on a scale | Standard Deviation 1.2 |
| Group ANC | Change in Ability to Identify Newborn Danger Signs | T1 (34 weeks gestation - 3 weeks postdelivery) | 1.8 units on a scale | Standard Deviation 1.3 |
| Stand ANC | Change in Ability to Identify Newborn Danger Signs | T0 Baseline at recruitment | 1.5 units on a scale | Standard Deviation 1.2 |
| Stand ANC | Change in Ability to Identify Newborn Danger Signs | T1 (34 weeks gestation - 3 weeks postdelivery) | 2.8 units on a scale | Standard Deviation 1.5 |
Primary
Change in Birth Preparedness and Complication Readiness
Change in the ability to identify a strategy for birth preparedness and complication readiness (BPCR) will be measured using a binary response (yes/no) to a question that ask participants if they have: (1) saved money, (2) identified birth facility for delivery, (3) identified emergency transportation to the facility, and (4) identified a blood donor. There is no validated or standardized instrument to measure BPCR. The measure used in this study is an open-end question: What are some things a woman can do to prepare for birth? Eleven possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 11. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Birth Preparedness and Complication Readiness | T0 | 1.4 units on a scale | Standard Deviation 0.9 |
| Group ANC | Change in Birth Preparedness and Complication Readiness | T1 (34 weeks gestation - 3 weeks postdelivery) | 2.9 units on a scale | Standard Deviation 1.5 |
| Stand ANC | Change in Birth Preparedness and Complication Readiness | T0 | 1.42 units on a scale | Standard Deviation 0.9 |
| Stand ANC | Change in Birth Preparedness and Complication Readiness | T1 (34 weeks gestation - 3 weeks postdelivery) | 1.7 units on a scale | Standard Deviation 1 |
Primary
Change in Health Literacy
Change in Health Literacy will be measured using the Maternal Health Literacy Scale. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 to T2. Maternal Health Literacy (MaHeLi) scale is a validated measure that consists of 12 yes-or-no questions to assess maternal health literacy among the participants. Raw item scores are a sum of individual responses; scores range from 0 to 12. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.
Time frame: T0 (Baseline at recruitment) and T2 (6 - 12 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T2 = 585 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T2 = 596
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Health Literacy | T0 - baseline | 9.6 score on a scale | Standard Deviation 1.7 |
| Group ANC | Change in Health Literacy | T2 - 6 weeks post-delivery | 11.3 score on a scale | Standard Deviation 0.9 |
| Stand ANC | Change in Health Literacy | T2 - 6 weeks post-delivery | 11 score on a scale | Standard Deviation 1.2 |
| Stand ANC | Change in Health Literacy | T0 - baseline | 9.7 score on a scale | Standard Deviation 1.6 |
Primary
Place of Delivery
Place of delivery will be measured using a self-report question (facility delivery, home delivery).
Time frame: T2 (6-12 weeks after delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Place of Delivery | Delivered at home | 18 Participants |
| Group ANC | Place of Delivery | Delivered at health facility | 567 Participants |
| Stand ANC | Place of Delivery | Delivered at home | 26 Participants |
| Stand ANC | Place of Delivery | Delivered at health facility | 567 Participants |
Secondary
Change in Ability to Identify Postpartum Danger Signs for Mother
Ability to identify danger signs after delivery will be measured utilizing a self-report, open ended, question that asks participants to identify warning signs that may occur after delivery (e.g. increased bleeding or large clots; weakness/fainting; fever; pain in abdominal or breast; painful urination, etc.). Change will be measured by calculating the difference in the mean at T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery). There is no validated or standardized instrument to measure postpartum danger signs. The measure used in this study is an open-end question: What are the danger signs for you, the mother, after the baby is born? Fourteen possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 14. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Ability to Identify Postpartum Danger Signs for Mother | T0 | 1.26 units on a scale | Standard Deviation 1.1 |
| Group ANC | Change in Ability to Identify Postpartum Danger Signs for Mother | T1 | 2.44 units on a scale | Standard Deviation 1.3 |
| Stand ANC | Change in Ability to Identify Postpartum Danger Signs for Mother | T0 | 1.17 units on a scale | Standard Deviation 1.1 |
| Stand ANC | Change in Ability to Identify Postpartum Danger Signs for Mother | T1 | 1.69 units on a scale | Standard Deviation 1.2 |
Secondary
Change in Ability to Identify the Recommended Action Steps When a Problem is Identified
Ability of mother to identify recommended action steps in response to danger signs that may occur before or after delivery. There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is the question: What do you think you would do if you have any of these (danger signs)? Responses are coded as Go to hospital or health facility CHECKED (1) or Go to hospital or health facility NOT CHECKED (0). Reported results are the sum of individual responses; higher score Go to hospital checked means a better outcome.
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T0 | Go to hospital or health facility CHECKED | 671 Participants |
| Group ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T0 | Go to hospital or health facility NOT CHECKED | 206 Participants |
| Group ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T1 | Go to hospital or health facility CHECKED | 594 Participants |
| Group ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T1 | Go to hospital or health facility NOT CHECKED | 23 Participants |
| Stand ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T1 | Go to hospital or health facility NOT CHECKED | 116 Participants |
| Stand ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T0 | Go to hospital or health facility CHECKED | 636 Participants |
| Stand ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T1 | Go to hospital or health facility CHECKED | 552 Participants |
| Stand ANC | Change in Ability to Identify the Recommended Action Steps When a Problem is Identified | T0 | Go to hospital or health facility NOT CHECKED | 248 Participants |
Secondary
Change in Intent to Use Family Planning
Intent to use family planning methods will be measured by self-report using a binary (yes/no) question that asks participants, Do you intend to use family planning after delivery?. Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated yes to their intent to use family planning after delivery. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T1( 34 weeks gestation - 3 weeks postdelivery).
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 747; Number of participants analyzed at T1 = 526 Standard ANC: Number of participants analyzed at T0 = 760; Number of participants analyzed at T1 = 525
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Intent to Use Family Planning | T0 | 0.38 units on a scale | Standard Deviation 0.5 |
| Group ANC | Change in Intent to Use Family Planning | T1 | 0.61 units on a scale | Standard Deviation 0.5 |
| Stand ANC | Change in Intent to Use Family Planning | T0 | 0.41 units on a scale | Standard Deviation 0.5 |
| Stand ANC | Change in Intent to Use Family Planning | T1 | 0.42 units on a scale | Standard Deviation 0.5 |
Secondary
Change in Interpersonal Violence
Experiences of physical, sexual, and emotional violence were measured using an investigator-derived questionnaire that asks participants if they experienced violence in the past year, and if resources and support are available to them. Raw item scores are a sum of individual responses; scores range from 0 to 9. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T4. Higher score means higher rates of reported sexual and emotional violence and lower access to resources and support. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T0 (baseline) to T4 (11 - 14 months postpartum)
Time frame: T0 (baseline) and T4 (11 - 14 months postpartum)
Population: Group ANC: Number of participants analyzed at T0 = 873 ; Number of participants analyzed at T4 = 626 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T4 = 686
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Interpersonal Violence | T0 | 4.48 units on a scale | Standard Deviation 1.4 |
| Group ANC | Change in Interpersonal Violence | T4 | 4.62 units on a scale | Standard Deviation 1 |
| Stand ANC | Change in Interpersonal Violence | T0 | 4.59 units on a scale | Standard Deviation 1.4 |
| Stand ANC | Change in Interpersonal Violence | T4 | 4.78 units on a scale | Standard Deviation 0.8 |
Secondary
Change in Knowledge of Family Planning Methods
Knowledge of family planning methods will be measured by self-report using a question that asks participants to identify all the methods of family planning they know. Change will be measured by calculating the difference in the mean at baseline and 3rd trimester. There is no validated or standardized instrument to measure this outcome, therefore the measure used in this study is an open-end question that asks participants to identify all the methods of family planning they know. Change will be measured by calculating the difference in the mean at T0 (baseline) and T1 (34 weeks gestation - 3 weeks postdelivery). There are eleven possible correct responses; raw item scores are a sum of individual responses; scores range from 0 to 11. Reported results are the average of all individual scores within the study arm. Change will be measured by calculating the difference in the mean at T0 and T1. Higher score means a better outcome.
Time frame: T0 (Baseline at recruitment) and T1 (34 weeks gestation - 3 weeks postdelivery)
Population: Group ANC: Number of participants analyzed at T0 = 877; Number of participants analyzed at T1 = 617 Standard ANC: Number of participants analyzed at T0 = 884; Number of participants analyzed at T1 = 668
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Knowledge of Family Planning Methods | T0 | 2.22 units on a scale | Standard Deviation 1.3 |
| Group ANC | Change in Knowledge of Family Planning Methods | T1 | 3.88 units on a scale | Standard Deviation 1.7 |
| Stand ANC | Change in Knowledge of Family Planning Methods | T0 | 2.01 units on a scale | Standard Deviation 1.39 |
| Stand ANC | Change in Knowledge of Family Planning Methods | T1 | 2.37 units on a scale | Standard Deviation 1.4 |
Secondary
Change in Uptake of Family Planning
Uptake of family planning will be measured by self-report using a binary (yes/no) question that asks participants if they are currently using any family planning method. Responses are coded as yes = 1 or no = 0. A higher number equals those who indicated yes to currently using family planning. Change over time will be analyzed using between group analysis and calculating the difference in the mean from T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum).
Time frame: T2 (6-12 weeks after delivery), T3 (5 - 8 months postpartum), and T4 (11 - 14 months postpartum)
Population: Group ANC: Number of participants analyzed at T2 = 585; Number analyzed at T3 = 619; Number analyzed at T4 = 609 Standard ANC: Number of participants analyzed at T0 592= ; Number analyzed at T1 = 673; Number analyzed at T4 = 674 Participants lost to follow-up at T2 and T3 remain eligible to complete surveys at subsequent timepoints. Thus, there may be more participants analyzed at later timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group ANC | Change in Uptake of Family Planning | T2 | 0.15 units on a scale | Standard Deviation 0.4 |
| Group ANC | Change in Uptake of Family Planning | T3 | 0.25 units on a scale | Standard Deviation 0.4 |
| Group ANC | Change in Uptake of Family Planning | T4 | 0.35 units on a scale | Standard Deviation 0.5 |
| Stand ANC | Change in Uptake of Family Planning | T2 | 0.09 units on a scale | Standard Deviation 0.3 |
| Stand ANC | Change in Uptake of Family Planning | T3 | 0.2 units on a scale | Standard Deviation 0.4 |
| Stand ANC | Change in Uptake of Family Planning | T4 | 0.43 units on a scale | Standard Deviation 0.5 |
Secondary
Completion of IPTp2 Malaria Prophylaxis During Pregnancy
Data gleaned from the participant's ANC/health record will be used to measure affirmative completion of IPTp2 malaria prophylaxis during pregnancy.
Time frame: T1 (34 weeks gestation - 3 weeks postdelivery)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Completion of IPTp2 Malaria Prophylaxis During Pregnancy | YES (completed IPTp2 malaria prophylaxis during pregnancy) | 375 Participants |
| Group ANC | Completion of IPTp2 Malaria Prophylaxis During Pregnancy | NO (did not complete IPTp2 malaria prophylaxis during pregnancy) | 237 Participants |
| Stand ANC | Completion of IPTp2 Malaria Prophylaxis During Pregnancy | YES (completed IPTp2 malaria prophylaxis during pregnancy) | 419 Participants |
| Stand ANC | Completion of IPTp2 Malaria Prophylaxis During Pregnancy | NO (did not complete IPTp2 malaria prophylaxis during pregnancy) | 238 Participants |
Secondary
Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy
Data gleaned from the participant's ANC/health record will be used to measure if the participant received least two tetanus toxoid vaccines during pregnancy.
Time frame: T1 (34 weeks gestation - 3 weeks postdelivery)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy | YES (received at least two tetanus toxoid vaccines during pregnancy) | 487 Participants |
| Group ANC | Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy | No (did not receive at least two tetanus toxoid vaccines during pregnancy) | 124 Participants |
| Stand ANC | Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy | YES (received at least two tetanus toxoid vaccines during pregnancy) | 518 Participants |
| Stand ANC | Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy | No (did not receive at least two tetanus toxoid vaccines during pregnancy) | 142 Participants |
Secondary
Experience of ANC Care
Experience of ANC care is measured using a twenty-one item investigator-derived questionnaire that asks participants about their experience regarding respectful care, satisfaction with care, and experience such as privacy and treatment with health system during their ANC visits. Raw item scores are a sum of individual responses; scores range from 0 to 21. Reported results are the average of all individual scores within the study arm. Higher score means a better outcome.
Time frame: T2 (6-12 postpartum)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group ANC | Experience of ANC Care | 20.1 units on a scale | Standard Deviation 1.4 |
| Stand ANC | Experience of ANC Care | 18.79 units on a scale | Standard Deviation 2.1 |
Secondary
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl).
Mother's hemoglobin at delivery; these data will be retrieved from the participant's ANC/health card and measured as hemoglobin in grams per deciliter (g/dl).
Time frame: T2 (6 - 12 weeks postpartum)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | Normal (>11) | 311 Participants |
| Group ANC | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | Severely anemic (< 7.5) | 4 Participants |
| Group ANC | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | Moderately anemic (> 7.5, <11) | 176 Participants |
| Stand ANC | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | Moderately anemic (> 7.5, <11) | 177 Participants |
| Stand ANC | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | Severely anemic (< 7.5) | 3 Participants |
| Stand ANC | Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl). | Normal (>11) | 313 Participants |
Secondary
Newborn Weight
Newborn weight in grams; these data will be retrieved from the participant's ANC/health card and measured as newborn weight.
Time frame: T2 (6-12 weeks postpartum)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group ANC | Newborn Weight | ≥ 2500 g | 459 Participants |
| Group ANC | Newborn Weight | < 2500 g | 33 Participants |
| Stand ANC | Newborn Weight | ≥ 2500 g | 431 Participants |
| Stand ANC | Newborn Weight | < 2500 g | 38 Participants |