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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

September 9, 2010
January 19, 2011
June 2008
May 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01199601 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Blood-borne Infection Screening in an Afghan Antenatal Population
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.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Prevalence of B SAg
  • Utilization of Postpartum Contraception
  • Breastfeeding Practices
  • Adherence to Infant Vaccination Schedules
Behavioral: Intrapartum, postpartum counseling
Intrapartum testing and concentrated counseling from a retrained provider
  • Counseling, retrained provider
    Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider
    Intervention: Behavioral: Intrapartum, postpartum counseling
  • Counseling existing providers
    Women receiving intra-partum testing and the usual post-partum counseling from existing cadres of hospital providers
    Intervention: Behavioral: Intrapartum, postpartum counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1291
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Afghanistan
 
NCT01199601
AAAD1784, 7K01TW007408-04
No
Catherine Todd, Columbia University
Columbia University
John E. Fogarty International Center (FIC)
Principal Investigator: Catherine Todd, MD Columbia University
Columbia University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP