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

This study is currently recruiting participants.
Verified October 2013 by Planned Parenthood League of Massachusetts
Sponsor:
Collaborator:
Society for Family Planning Research Fund
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT01854671
First received: May 13, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Focus: Contraceptive Counseling
Focus: Postpartum Contraception
Other: family planning counseling let by community health workers

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • Self-reported contraceptive use [ Time Frame: 6 months post-partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intent to use contraception in the future [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
  • Non-desire to use contraception [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 158
Study Start Date: August 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854671

Contacts
Contact: Principal Investigator, MD, MPH 617.616.1600

Locations
Palestinian Territories, Occupied
Palestinian Ministry of Health Maternal Child Health Clinics (Ramallah and Al-Bireh) Recruiting
Ramallah and Al-Bireh, West Bank, Palestinian Territories, Occupied
Contact: Central Contact, MD, MPH         
Principal Investigator: Co Investigator, MD MPH         
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society for Family Planning Research Fund
Investigators
Principal Investigator: Principal Investigator, MD, MPH Planned Parenthood League of Massachusetts
  More Information

No publications provided

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01854671     History of Changes
Other Study ID Numbers: SFPRF13-10
Study First Received: May 13, 2013
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board
Palestine: Palestinian Ministry of Health
Palestine: Ethics Board

Keywords provided by Planned Parenthood League of Massachusetts:
postpartum contraception
contraceptive counseling

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014