Blood-borne Infection Screening in an Afghan Antenatal Population

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Catherine S. Todd, Columbia University
ClinicalTrials.gov Identifier:
NCT01199601
First received: September 9, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Viral Hepatitis B
Contraception
Breast Feeding, Exclusive
Effects of; Lack of Care of Infants
Behavioral: Concentrated postpartum counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Utilization of Postpartum Contraception [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Correct Breastfeeding Practices to 1 Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 1291
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concentrated postpartum counseling
Women randomized to receiving concentrated postpartum counseling from the retrained provider.
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.
No Intervention: Routine postpartum counseling
Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care.

Detailed 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.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199601

Locations
Afghanistan
Maternity Hospitals
Kabul, Afghanistan
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Catherine Todd, MD Columbia University
  More Information

No publications provided

Responsible Party: Catherine S. Todd, Adjct Assoc Research Scientist, Columbia University
ClinicalTrials.gov Identifier: NCT01199601     History of Changes
Other Study ID Numbers: AAAD1784, 7K01TW007408-04
Study First Received: September 9, 2010
Results First Received: September 4, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board
Afghanistan: Ministry of Public Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 20, 2014