NCT04306029

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2021

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

March 5, 2020

Last Update Submit

January 19, 2022

Conditions

Contraception

Outcome Measures

Primary Outcomes (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)

Study Arms (2)

Pre-Intervention

NO INTERVENTION

Post-Intervention

EXPERIMENTAL

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

Interventions

Postpartum Family Planning PackageOTHER

"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.

Post-Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Providers who care for postpartum women on the inpatient postpartum ward, including midwives, nurses, residents, fellows, and consultant physicians.

You may not qualify if:

  • Students caring for postpartum patients on the postpartum ward.
  • \- 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.
  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nsawam Goverment Hospital

Nsawam, Eastern Region, Ghana

Location

Ga West Municipal Hospital

Amasaman, Greater Accra Region, Ghana

Location

Maamobi Hospital

Accra, Ghana

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Hybrid Type II implementation and effectiveness study using a quasi-experimental stepped-wedge design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 12, 2020

Study Start

February 24, 2020

Primary Completion

October 1, 2021

Study Completion

November 16, 2021

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GH(3)