Improving Adherence to Postpartum Family Planning Guidance in Ghana

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04306029
• Collaborator: World Health Organization (Other), University of Ghana (Other)
• Enrollment: 2,142
• Locations: 3
• Arms: 2
• Actual Duration (Months): 20.7
• Patients Per Site: 714
• Patients Per Site Per Month: 34.4

Study Details

Study Description

Brief Summary

Evaluating a Postpartum Family Planning Package (PPFP) in a Hybrid Type II implementation study with a stepped-wedge design.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Other: Postpartum Family Planning Package	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2142 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Hybrid Type II implementation and effectiveness study using a quasi-experimental stepped-wedge design.Hybrid Type II implementation and effectiveness study using a quasi-experimental stepped-wedge design.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Adherence to Postpartum Family Planning Guidance in Ghana: a Hybrid Type 2 Implementation and Effectiveness Study
• Actual Study Start Date: Feb 24, 2020
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Nov 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Pre-Intervention
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.	Other: Postpartum Family Planning Package; "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.

Outcome Measures

Primary Outcome Measures

1. Provider discussed all guideline-appropriate contraceptive methods as defined by World Health Organization Medical Eligibility Criteria (yes/no) [During postpartum inpatient stay, prior to hospital discharge (approximately 2 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nsawam Goverment Hospital	Nsawam	Eastern Region	Ghana
2	Ga West Municipal Hospital	Amasaman	Greater Accra	Ghana
3	Maamobi Hospital	Accra		Ghana

Sponsors and Collaborators

• University of Pennsylvania
• World Health Organization
• University of Ghana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04306029
• Other Study ID Numbers: 834804
• First Posted: Mar 12, 2020
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 21, 2022