Contraception Clinical Trial
Official title:
Pilot Educational Intervention to Determine Effect of Intrapartum Testing and Concentrated Postpartum Counseling on Birth Spacing, Breastfeeding, and Infant Vaccination Completion in a Kabul Urban Population.
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.
Outcomes will be assessed through questionnaire responses and inspection of vaccination
cards at six month intervals by trained study staff. The third aim will be addressed at the
12 month follow-up visit.
Status | Completed |
Enrollment | 1291 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 14 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Afghanistan | Maternity Hospitals | Kabul |
Lead Sponsor | Collaborator |
---|---|
Columbia University | John E. Fogarty International Center (FIC) |
Afghanistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 12 months | No |
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. | 12 months | No |
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. | 12 months | No |
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