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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

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ClinicalTrials.gov Identifier: NCT01854671
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : August 17, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Self-reported contraceptive use [ Time Frame: 6 months post-partum ]

Secondary Outcome Measures :
  1. Intent to use contraception in the future [ Time Frame: 6 months postpartum ]
  2. Non-desire to use contraception [ Time Frame: 6 months postpartum ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854671


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

Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01854671     History of Changes
Other Study ID Numbers: SFPRF13-10
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015

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