- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04306029
Improving Adherence to Postpartum Family Planning Guidance in Ghana
January 19, 2022 updated by: University of Pennsylvania
Improving Adherence to Postpartum Family Planning Guidance in Ghana: a Hybrid Type 2 Implementation and Effectiveness Study
Evaluating a Postpartum Family Planning Package (PPFP) in a Hybrid Type II implementation study with a stepped-wedge design.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our overarching goal is to enable providers to consistently offer and deliver highly effective postpartum family planning methods in accordance with international guidelines.
Our primary objective in this research is to assess the implementation and effectiveness of the "Postpartum Family Planning Package (PFPP)," an implementation strategy that consists of the following components: 1) a provider training on contraceptive methods available in the immediate postpartum period, and techniques for their placement in the case of intrauterine devices and implants, with quarterly booster trainings, and 2) promotion of the WHO MEC/Postpartum Family Planning Compendium mobile application as a provider decision tool to aid in postpartum family planning counselling.
Study Type
Interventional
Enrollment (Actual)
2142
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
-
-
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Accra, Ghana
- Maamobi Hospital
-
-
Eastern Region
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Nsawam, Eastern Region, Ghana
- Nsawam Goverment Hospital
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Greater Accra
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Amasaman, Greater Accra, Ghana
- Ga West Municipal Hospital
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-
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
Provider Inclusion Criteria:
- Providers who care for postpartum women on the inpatient postpartum ward, including midwives, nurses, residents, fellows, and consultant physicians.
Provider Exclusion Criteria:
- Students caring for postpartum patients on the postpartum ward.
Client Inclusion Criteria:
- Women receiving antenatal care who have the potential to be admitted to the inpatient postpartum ward following delivery, or women admitted in the postpartum ward.
Client Exclusion Criteria:
- None
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-Intervention
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|
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Experimental: Post-Intervention
Postpartum staff has received the "Postpartum Family Planning Package," which consists of provider education on contraceptive delivery in the immediate postpartum period and promotion of the WHO MEC/PFP Compendium mobile application.
|
"Postpartum Family Planning Package," which consists of provider education on contraceptive delivery in the immediate postpartum period and promotion of the WHO MEC/PFP Compendium mobile application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Provider discussed all guideline-appropriate contraceptive methods as defined by World Health Organization Medical Eligibility Criteria (yes/no)
Time Frame: During postpartum inpatient stay, prior to hospital discharge (approximately 2 days)
|
During postpartum inpatient stay, prior to hospital discharge (approximately 2 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 24, 2020
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
November 16, 2021
Study Registration Dates
First Submitted
March 5, 2020
First Submitted That Met QC Criteria
March 9, 2020
First Posted (Actual)
March 12, 2020
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 834804
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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