Blood-borne Infection Screening in an Afghan Antenatal Population

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199601
• Other study ID #: AAAD1784
• Secondary ID: 7K01TW007408-04
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: February 12, 2014
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardAfghanistan: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Description:

Baseline information indicates a measurable prevalence of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan. This intervention randomizes providers at maternity hospitals to assess the following aims:

Aim 1: To determine whether the re-training and assignment of health care providers dedicated to intrapartum hepatitis B rapid testing and postpartum counseling will positively impact maternal and neonatal health indicators as compared to utilization of existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.

Aim 2: To assess whether patients randomized to the intervention and their spouses perceive value in concentrated postpartum counseling.

Aim 3: To investigate whether an intervention providing immediate postpartum provision of a long-acting family planning method would be feasible and acceptable to both men and women in Kabul, Afghanistan.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Contraception
• Effects of; Lack of Care of Infants
• Hepatitis B
• Viral Hepatitis B

Intervention

Behavioral:
• Concentrated 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.

Locations

Country	Name	City	State
Afghanistan	Maternity Hospitals	Kabul

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	John E. Fogarty International Center (FIC)

Country where clinical trial is conducted

Afghanistan, 

Outcome

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