Breast Feeding, Exclusive, Contraception, Effects of; Lack of Care of Infants, Viral Hepatitis B
Conditions
Brief summary
Baseline information indicates there are measurable levels of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize hospitals to assess the following aims: Aim 1: To determine whether the re-training and assignment of health care providers dedicated to intrapartum rapid testing and post-partum counseling will positively impact maternal and neonatal health indicators as compared to utilization of existing health providers for these services among women delivering in publish health maternity hospitals in Kabul, Afghanistan. Aim 2: To assess whether patients randomized to the intervention and their spouses perceive value in concentrated post-partum counseling. Aim 3: To investigate whether an intervention providing immediate post-partum provision of a long-acting family planning method would be feasible and acceptable to both men and women in Kabul, Afghanistan.
Detailed description
Outcomes are assessed through questionnaire responses and inspection of vaccination cards at six month intervals by trained study staff through one year total study time. Differences between groups will be assessed with generalized linear mixed modeling. Information obtained to address Aim 3 will be gathered at the 12 month follow-up and analyzed with simple proportions and Chi-square test to assess differences between sexes and other socioeconomic indicators.
Interventions
BEHAVIORALConcentrated postpartum counseling
Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.
Sponsors
Fogarty International Center of the National Institute of Health
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* admitted for obstetric care * Dari or Pashto speaking * not previously participated in the study * in medically stable condition * accompanied by and have approval of a spouse * able to provide informed consent Male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent.
Exclusion criteria
* medically unstable or imminently delivering (complete cervical dilation) * husband unavailable or does not approve participation * unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Utilization of Postpartum Contraception | 12 months | Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correct Breastfeeding Practices to 1 Year | 12 months | Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care. |
| Completion of 9 Month Measles-mumps-rubella Vaccination on Time. | 12 months | Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care. |
Countries
Afghanistan
Participant flow
Recruitment details
Women in active labor able to provide consent recruited by random number designation at four Kabul public maternity hospitals following admission. Recruitment occurred from June 2008 through January 2009.
Participants by arm
| Arm | Count |
|---|---|
| Counseling Existing Providers Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .
Intrapartum, postpartum counseling : Intrapartum testing and routine counseling. | 422 |
| Counseling, Retrained Provider Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).
Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider | 422 |
| Total | 844 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Insecurity prevented staff interviewing. | 7 | 9 |
| Overall Study | Lost to Follow-up | 47 | 66 |
| Overall Study | Withdrawal by Subject | 15 | 3 |
Baseline characteristics
| Characteristic | Counseling, Retrained Provider | Total | Counseling Existing Providers |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 65 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 391 Participants | 779 Participants | 388 Participants |
| Age, Continuous | 24.8 years STANDARD_DEVIATION 5.5 | 24.9 years STANDARD_DEVIATION 5.5 | 25.1 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment Afghanistan | 422 participants | 844 participants | 422 participants |
| Sex: Female, Male Female | 422 Participants | 844 Participants | 422 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 | — / — | — / — |
| other Total, other adverse events | 0 / 422 | 0 / 422 |
| serious Total, serious adverse events | 0 / 422 | 0 / 422 |
Outcome results
Primary
Utilization of Postpartum Contraception
Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.
Time frame: 12 months
Population: Participants included in analysis were those completing the 6 and 12 month follow-up visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counseling Existing Providers | Utilization of Postpartum Contraception | 199 participants |
| Counseling, Retrained Provider | Utilization of Postpartum Contraception | 213 participants |
Comparison: Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.p-value: <0.0595% CI: [1.02, 1.23]Regression, Linear
Secondary
Completion of 9 Month Measles-mumps-rubella Vaccination on Time.
Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counseling Existing Providers | Completion of 9 Month Measles-mumps-rubella Vaccination on Time. | 211 participants |
| Counseling, Retrained Provider | Completion of 9 Month Measles-mumps-rubella Vaccination on Time. | 235 participants |
p-value: 0.0595% CI: [1.01, 1.25]Regression, Logistic
Secondary
Correct Breastfeeding Practices to 1 Year
Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counseling Existing Providers | Correct Breastfeeding Practices to 1 Year | 198 participants |
| Counseling, Retrained Provider | Correct Breastfeeding Practices to 1 Year | 240 participants |
p-value: <0.0595% CI: [1.02, 1.18]Regression, Linear