Blood-borne Infection Screening in an Afghan Antenatal Population

Not Applicable

Completed

• Conditions: Contraception; Effects of; Lack of Care of Infants; Viral Hepatitis B; Breast Feeding, Exclusive
• Interventions: Behavioral: Concentrated postpartum counseling

• Registration Number: NCT01199601
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-13
• Results First Submitted: 2013-09-04
• Results First Submitted QC: 2014-02-12
• Results First Posted: 2014-03-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1291

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.

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Exclusion Criteria

• medically unstable or imminently delivering (complete cervical dilation)
• husband unavailable or does not approve participation
• unable to provide consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentrated postpartum counseling	Concentrated postpartum counseling	Women randomized to receiving concentrated postpartum counseling from the retrained provider.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Maternity Hospitals; 🇦🇫 Kabul, Afghanistan