ContraceptionNCT04306029
Improving Adherence to Postpartum Family Planning Guidance in Ghana
A study testing Postpartum Family Planning Package in people with Contraception, run by University of Pennsylvania at 3 sites in Ghana.
Trial summary
Evaluating a Postpartum Family Planning Package (PPFP) in a Hybrid Type II implementation study with a stepped-wedge design. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Postpartum Family Planning Package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,142 participants
- Where
- 3 sitesGhana
- Study dates
- 24 Feb 2020to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
Ghana3 sites
Maamobi Hospital
Accra
Ga West Municipal Hospital
Amasaman, Greater Accra Region
Nsawam Goverment Hospital
Nsawam, Eastern Region
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Postpartum Family Planning Package
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No intervention | Not described |
| 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. Receives: Other: Postpartum Family Planning Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider discussed all guideline-appropriate contraceptive methods as defined by World Health Organization Medical Eligibility Criteria (yes/no)
Measured: During postpartum inpatient stay, prior to hospital discharge (approximately 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start24 Feb 2020
- Primary completion1 Oct 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Hybrid Type II implementation and effectiveness study using a quasi-experimental stepped-wedge design.
- Masking
- None (open label)
- Enrolment
- 2,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, University of Ghana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306029
- Sponsor's protocol ID
- 834804
- Status last verified
- Jan 2022
- First submitted
- 5 Mar 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Postpartum Family Planning Guidance in Ghana: a Hybrid Type 2 Implementation and Effectiveness Study
- ClinicalTrials.gov ID
- NCT04306029
- Acronym / sponsor ID
- 834804
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,142 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- World Health Organization, University of Ghana
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating a Postpartum Family Planning Package (PPFP) in a Hybrid Type II implementation study with a stepped-wedge design.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid Type II implementation and effectiveness study using a quasi-experimental stepped-wedge design.
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No intervention | – |
| Post-Intervention | Experimental | Other: Postpartum Family Planning PackagePostpartum 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Post-Intervention |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Family Planning Package in people with Contraception, run by University of Pennsylvania at 3 sites in Ghana.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.