Clinical trial NCT01199601: Blood-borne Infection Screening in an Afghan Antenatal Population
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Hepatitis B
Contraception
Breast Feeding, Exclusive
Effects of; Lack of Care of Infants
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2010-09-13
Enrollment: 1291
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Utilization of Postpartum Contraception
timeFrame: 12 months
Secondary outcomes:
measure: Correct Breastfeeding Practices to 1 Year
timeFrame: 12 months
measure: Completion of 9 Month Measles-mumps-rubella Vaccination on Time.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kabul
country: Afghanistan
facility: Maternity Hospitals
Study officials:
affiliation: Columbia University
name: Catherine Todd, MD
role: PRINCIPAL_INVESTIGATOR
References: