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
Results First Received: September 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Viral Hepatitis B
Contraception
Breast Feeding, Exclusive
Effects of; Lack of Care of Infants
Intervention: Behavioral: Concentrated postpartum counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women in active labor able to provide consent recruited by random number designation at four Kabul public maternity hospitals following admission. Recruitment occurred from June 2008 through January 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
Counseling Existing Providers

Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group.

Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study.

Counseling, Retrained Provider

Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention)

Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider


Participant Flow:   Overall Study
    Counseling Existing Providers     Counseling, Retrained Provider  
STARTED     422 [1]   422 [2]
COMPLETED     353     344  
NOT COMPLETED     69     78  
Lost to Follow-up                 47                 66  
Withdrawal by Subject                 15                 3  
Insecurity prevented staff interviewing.                 7                 9  
[1] Control Group
[2] Intervention Group



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The 1291 reflects the husbands interviewed at 12 months (n=447). The husbands were not analyzed as part of the RCT.

Reporting Groups
  Description
Counseling Existing Providers

Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .

Intrapartum, postpartum counseling : Intrapartum testing and routine counseling.

Counseling, Retrained Provider

Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).

Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider

Total Total of all reporting groups

Baseline Measures
    Counseling Existing Providers     Counseling, Retrained Provider     Total  
Number of Participants  
[units: participants]
  422     422     844  
Age  
[units: participants]
     
<=18 years     34     31     65  
Between 18 and 65 years     388     391     779  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.1  ± 5.6     24.8  ± 5.5     24.9  ± 5.5  
Gender  
[units: participants]
     
Female     422     422     844  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Afghanistan     422     422     844  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Utilization of Postpartum Contraception   [ Time Frame: 12 months ]

2.  Secondary:   Correct Breastfeeding Practices to 1 Year   [ Time Frame: 12 months ]

3.  Secondary:   Completion of 9 Month Measles-mumps-rubella Vaccination on Time.   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Catherine Todd
Organization: Columbia University
phone: 212-305-4805
e-mail: cst2121@columbia.edu


No publications provided


Responsible Party: Catherine S. Todd, 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