Investigating the Effect of a Prenatal Family Planning Counseling Intervention Led by Community Health Workers on Postpartum Contraceptive Use Among Women in the West Bank

August 14, 2015 updated by: Planned Parenthood League of Massachusetts

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Palestinian Territories, Occupied
    • West Bank
      • Ramallah and Al-Bireh, West Bank, Palestinian Territories, Occupied
        • Palestinian Ministry of Health Maternal Child Health Clinics (Ramallah and Al-Bireh)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
Experimental: family planning counseling led by community health worker
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported contraceptive use
Time Frame: 6 months post-partum
6 months post-partum

Secondary Outcome Measures

Outcome Measure
Time Frame
Intent to use contraception in the future
Time Frame: 6 months postpartum
6 months postpartum
Non-desire to use contraception
Time Frame: 6 months postpartum
6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood League of Massachusetts

Collaborators

Society for Family Planning Research Fund

Investigators

  • Principal Investigator: Principal Investigator, MD, MPH, Planned Parenthood League of Massachusetts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SFPRF13-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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