NCT01854671

Brief Summary

The purpose of this study is to measure the difference in proportion of postpartum women using contraception after a Community Health Worker (CHW) family planning educational intervention compared to women who receive standard care in the West Bank district of Ramallah and Al-Bireh. Primary hypothesis: Postpartum contraceptive use will increase in women who receive a dedicated family planning counseling intervention delivered by CHWs during antenatal care compared to women receiving usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

May 13, 2013

Last Update Submit

August 14, 2015

Conditions

Keywords

postpartum contraceptioncontraceptive counseling

Outcome Measures

Primary Outcomes (1)

  • Self-reported contraceptive use

    6 months post-partum

Secondary Outcomes (2)

  • Intent to use contraception in the future

    6 months postpartum

  • Non-desire to use contraception

    6 months postpartum

Study Arms (2)

standard care

NO INTERVENTION

family planning counseling led by community health worker

EXPERIMENTAL

The family planning counseling sessions led by community health workers will present advantages of birth spacing, available methods of postpartum contraception, contraindications (if any) for the method, when each method can be safely started postpartum, where each method can be obtained, and importance of 6 week postpartum clinic follow-up. There will also be a take-home contraceptive method brochure given at conclusion of information session -primarily pictorial and in Arabic, to facilitate discussion at home with husbands and family members.

Other: family planning counseling let by community health workers

Interventions

The family planning counseling sessions led by community health workers will present advantages of birth spacing, available methods of postpartum contraception, contraindications (if any) for the method, when each method can be safely started postpartum, where each method can be obtained, and importance of 6 week postpartum clinic follow-up. There will also be a take-home contraceptive method brochure given at conclusion of information session -primarily pictorial and in Arabic, to facilitate discussion at home with husbands and family members.

family planning counseling led by community health worker

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women attending the MoH Ramallah or Al-Bireh clinic for antenatal care and 34-38 weeks pregnant at enrollment
  • Planning delivery at an MoH hospital
  • Able and willing to be contacted by phone or home visit

You may not qualify if:

  • Women less than 34 weeks pregnant or non-pregnant
  • Planning delivery at a private or NGO hospital
  • Unwilling to be contacted for follow-up after enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestinian Ministry of Health Maternal Child Health Clinics (Ramallah and Al-Bireh)

Ramallah and Al-Bireh, West Bank, Palestinian Territories

Location

Study Officials

  • Principal Investigator, MD, MPH

    Planned Parenthood League of Massachusetts

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 15, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations