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

September 9, 2010
February 12, 2014
June 2008
May 2010   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01199601 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Viral Hepatitis B
  • Contraception
  • Breast Feeding, Exclusive
  • Effects of; Lack of Care of Infants
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.
  • Experimental: Concentrated postpartum counseling
    Women randomized to receiving concentrated postpartum counseling from the retrained provider.
    Intervention: Behavioral: Concentrated postpartum counseling
  • No Intervention: Routine postpartum counseling
    Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care.
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
14 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Afghanistan
 
NCT01199601
AAAD1784, 7K01TW007408-04
No
Catherine S. Todd, Columbia University
Columbia University
John E. Fogarty International Center (FIC)
Principal Investigator: Catherine Todd, MD Columbia University
Columbia University
February 2014

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