Blood-borne Infection Screening in an Afghan Antenatal Population
Primary Purpose
Viral Hepatitis B, Contraception, Breast Feeding, Exclusive
Status
Completed
Phase
Not Applicable
Locations
Afghanistan
Study Type
Interventional
Intervention
Concentrated postpartum counseling
Sponsored by
About this trial
This is an interventional other trial for Viral Hepatitis B
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
Sites / Locations
- Maternity Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Concentrated postpartum counseling
Routine postpartum counseling
Arm Description
Women randomized to receiving concentrated postpartum counseling from the retrained provider.
Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care.
Outcomes
Primary Outcome Measures
Utilization of Postpartum Contraception
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
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.
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.
Full Information
NCT ID
NCT01199601
First Posted
September 9, 2010
Last Updated
April 17, 2017
Sponsor
Columbia University
Collaborators
Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT01199601
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Fogarty International Center of the National Institute of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Hepatitis B, Contraception, Breast Feeding, Exclusive, Effects of; Lack of Care of Infants
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concentrated postpartum counseling
Arm Type
Experimental
Arm Description
Women randomized to receiving concentrated postpartum counseling from the retrained provider.
Arm Title
Routine postpartum counseling
Arm Type
No Intervention
Arm Description
Women receiving intra-partum testing and post-partum counseling from existing cadres of hospital providers at standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Concentrated postpartum counseling
Intervention Description
Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.
Primary Outcome Measure Information:
Title
Utilization of Postpartum Contraception
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Correct Breastfeeding Practices to 1 Year
Description
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.
Time Frame
12 months
Title
Completion of 9 Month Measles-mumps-rubella Vaccination on Time.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Todd, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity Hospitals
City
Kabul
Country
Afghanistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Blood-borne Infection Screening in an Afghan Antenatal Population
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