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Blood-borne Infection Screening in an Afghan Antenatal Population

This study has been completed.
Sponsor:
Collaborator:
John E. Fogarty International Center (FIC)
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT01199601
First received: September 9, 2010
Last updated: January 19, 2011
Last verified: September 2010
History of Changes
  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
Prevalence of B SAg
Utilization of Postpartum Contraception
Breastfeeding Practices
Adherence to Infant Vaccination Schedules
 Behavioral: Intrapartum, 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:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Intrapartum rapid testing and post-partum counseling impact on maternal and neonatal health indicators. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine whether the re-trianing and assignment of healthcare providers dedicated to intrapartum rapid testing and post-partum counseling will positively impact materanl 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.


Secondary Outcome Measures:
  • Value of postpartum counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess whether patients randomized to the intervention and their spouses perceive value in concentrated post-partum counseling

  • Long acting family planning method [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Investigate whether an intervention providing immediate post-partum provision of a long-acting family planning method would be feasible and acceptableto both men and women in Kabul, Afghanistan.


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
Counseling, retrained provider
Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider
 Behavioral: Intrapartum, postpartum counseling
Intrapartum testing and concentrated counseling from a retrained provider
Counseling existing providers
Women receiving intra-partum testing and the usual post-partum counseling from existing cadres of hospital providers
 Behavioral: Intrapartum, postpartum counseling
Intrapartum testing and concentrated counseling from a retrained provider

  Eligibility

Ages Eligible for Study:   8 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
John E. Fogarty International Center (FIC)
Investigators
Principal Investigator: Catherine Todd, MD Columbia University
  More Information

No publications provided

Responsible Party: Catherine Todd, Columbia University
ClinicalTrials.gov Identifier: NCT01199601     History of Changes
Other Study ID Numbers: AAAD1784, 7K01TW007408-04
Study First Received: September 9, 2010
Last Updated: January 19, 2011
Health Authority: United States: Institutional Review Board
Afghanistan: Ministry of Public Health

ClinicalTrials.gov processed this record on May 22, 2013