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 ongoing, but not recruiting participants.
Sponsor:
Planned Parenthood League of Massachusetts
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: May 2, 2014
Last verified: May 2014
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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: | August 2014 |
| Estimated Primary Completion Date: | August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854671
Please refer to this study by its ClinicalTrials.gov identifier: 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
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: | May 2, 2014 |
| 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 Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015