Trial Outcomes & Findings for Blood-borne Infection Screening in an Afghan Antenatal Population (NCT NCT01199601)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1291 participants

Primary outcome timeframe

12 months

Results posted on

2017-05-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	422	422
Overall Study COMPLETED	353	344
Overall Study NOT COMPLETED	69	78

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	47	66
Overall Study Withdrawal by Subject	15	3
Overall Study Insecurity prevented staff interviewing.	7	9

Baseline Characteristics

Blood-borne Infection Screening in an Afghan Antenatal Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Counseling Existing Providers n=422 Participants 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 n=422 Participants 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 n=844 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=39 Participants	31 Participants n=41 Participants	65 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	388 Participants n=39 Participants	391 Participants n=41 Participants	779 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	25.1 years STANDARD_DEVIATION 5.6 • n=39 Participants	24.8 years STANDARD_DEVIATION 5.5 • n=41 Participants	24.9 years STANDARD_DEVIATION 5.5 • n=35 Participants
Sex: Female, Male Female	422 Participants n=39 Participants	422 Participants n=41 Participants	844 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment Afghanistan	422 participants n=39 Participants	422 participants n=41 Participants	844 participants n=35 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Participants included in analysis were those completing the 6 and 12 month follow-up visits.

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.

Outcome measures

Outcome measures
Measure	Counseling Existing Providers n=353 Participants Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group. Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study.	Counseling, Retrained Provider n=344 Participants Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider
Utilization of Postpartum Contraception	199 participants	213 participants

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Counseling Existing Providers n=353 Participants Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group. Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study.	Counseling, Retrained Provider n=344 Participants Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider
Correct Breastfeeding Practices to 1 Year	198 participants	240 participants

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Counseling Existing Providers n=353 Participants Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group. Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study.	Counseling, Retrained Provider n=344 Participants Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider
Completion of 9 Month Measles-mumps-rubella Vaccination on Time.	211 participants	235 participants

Adverse Events

Counseling Existing Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Counseling, Retrained Provider

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Catherine Todd

Columbia University

Phone: 212-305-4805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place