ContraceptionEPINCT04767139
EPI, a Missed Opportunity for Postpartum Family Planning Utilization
An observational study of Contraception, run by Hawassa University at 1 site in Ethiopia.
Trial summary
The global unmet need for postpartum family planning remains high, while immunization services are among the most widely utilized health services. Most women in the extended postpartum period want to delay or avoid future pregnancies but many are not using a modern contraceptive method. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- counseling for family planning
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 1,474 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Feb 2020to 28 Oct 2022
- Phase
- Observational
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: All women in the extended postpartum period visiting the selected health centers for infant immunization service are the study populations.
Who may be able to join
- all women visiting the selected health facilities at least two times during the pre-intervention period will be included
Who cannot join
- No exclussion critera
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanded Program for Immunization, a Missed Opportunity for Postpartum Family Planning Utilization: A Quasi Experimental Study
The global unmet need for postpartum family planning remains high, while immunization services are among the most widely utilized health services. Most women in the extended postpartum period want to delay or avoid future pregnancies but many are not using a modern contraceptive method. Establishing systematic screening, counseling, and referral systems from different contact points particularly from infant immunization units may improve family planning access and uptake in the extended postpartum period. Hence, this study is aimed to assess the effect of counseling for family planning at immunization units on postpartum contraceptive uptake during the extended postpartum period.
Read the detailed description
Background: The global unmet need for postpartum family planning remains high, while immunization services are among the most widely utilized health services. Most women in the extended postpartum period want to delay or avoid future pregnancies but many are not using a modern contraceptive method. Establishing systematic screening, counseling, and referral systems from different contact points particularly from Expanded Program for Immunization (EPI) units may improve family planning access and uptake in the extended perinatal period.
Therefore, this study is proposed to assess the effect of counseling for family planning at immunization units on postpartum contraceptive uptake during the extended postpartum period.
To do this, a before-and-after type of quasi-experimental study will be conducted in purposively selected health centers in Sidama, South Ethiopia. All mothers coming to the selected health centers for infant immunization services will be screened for, counseled, and referred for family planning. A structured interviewer-administered questionnaire will be used to collect quantitative data from a total of 1474 randomly selected women coming to purposively selected health centers before and after the intervention. Bivariate and multivariable logistic regression analysis adjusting for possible confounding variables will be computed.
- Conditions
- Contraception
- Being tested
- counseling for family planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling for family planningBehavioural
all mothers presented to infant immunization units of the selected health centers will be counseled for family planning service and referred to the family planning unit if they decided to use.
| Study group | Role | What they receive |
|---|---|---|
| pre-intervention group | mothers included for the pre-intervention assessment of contraceptive prevalence rate in the selected health centers | |
| post intervention group | mothers included for the post-intervention assessment of contraceptive prevalence rate in the selected health centers Receives: Behavioral: counseling for family planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved contraceptive uptake
the contraceptive utilization rate will be increased after the initiation of the intervention
Measured: March 3, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Feb 2020
- Primary completion25 Feb 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawassa University
- Sponsor type
- University, hospital or other
- Collaborators
- EngenderHealth
- Responsible party
- Principal investigator, Abebaw Abeje Muluneh, Hawassa University
- Investigators
- Abebaw Abeje Muluneh, MSc, Principal investigator, Hawassa UniversityAbel Gedefaw, MD, MPh, Study chair, Hawassa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767139
- Sponsor's protocol ID
- g6t4n7gi
- Acronym
- EPI
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muluneh AA, Gedefaw A, Kelaye T, Sisay F, Worku M, Astatkie A, Shiferaw S. Addressing a missed opportunity for contraceptive use during the extended postpartum period by integrating it with infant immunization services in Sidama Region, Ethiopia: A quasi-experimental study. PLOS Glob Public Health. 2024 Jun 25;4(6):e0003236. doi: 10.1371/journal.pgph.0003236. eCollection 2024.
PubMed 38917099
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Program for Immunization, a Missed Opportunity for Postpartum Family Planning Utilization: A Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT04767139
- Acronym / sponsor ID
- EPI / g6t4n7gi
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,474 participants (actual)
- Lead sponsor
- Hawassa UniversityUniversity, hospital or other
- Collaborators
- EngenderHealth
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 23 Feb 2021 (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.
The global unmet need for postpartum family planning remains high, while immunization services are among the most widely utilized health services. Most women in the extended postpartum period want to delay or avoid future pregnancies but many are not using a modern contraceptive method. Establishing systematic screening, counseling, and referral systems from different contact points particularly from infant immunization units may improve family planning access and uptake in the extended postpartum period. Hence, this study is aimed to assess the effect of counseling for family planning at immunization units on postpartum contraceptive uptake during the extended postpartum period.
Detailed description
Background: The global unmet need for postpartum family planning remains high, while immunization services are among the most widely utilized health services. Most women in the extended postpartum period want to delay or avoid future pregnancies but many are not using a modern contraceptive method. Establishing systematic screening, counseling, and referral systems from different contact points particularly from Expanded Program for Immunization (EPI) units may improve family planning access and uptake in the extended perinatal period.
Therefore, this study is proposed to assess the effect of counseling for family planning at immunization units on postpartum contraceptive uptake during the extended postpartum period.
To do this, a before-and-after type of quasi-experimental study will be conducted in purposively selected health centers in Sidama, South Ethiopia. All mothers coming to the selected health centers for infant immunization services will be screened for, counseled, and referred for family planning. A structured interviewer-administered questionnaire will be used to collect quantitative data from a total of 1474 randomly selected women coming to purposively selected health centers before and after the intervention. Bivariate and multivariable logistic regression analysis adjusting for possible confounding variables will be computed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-intervention group | – | –mothers included for the pre-intervention assessment of contraceptive prevalence rate in the selected health centers |
| post intervention group | – | Behavioral: counseling for family planningmothers included for the post-intervention assessment of contraceptive prevalence rate in the selected health centers |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All women in the extended postpartum period visiting the selected health centers for infant immunization service are the study populations.
Key inclusion criteria (1 listed)
- all women visiting the selected health facilities at least two times during the pre-intervention period will be included
Key exclusion criteria (1 listed)
- No exclussion critera
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 |
|---|---|---|
| counseling for family planningall mothers presented to infant immunization units of the selected health centers will be counseled for family planning service and referred to the family planning unit if they decided to use. | Behavioural | post intervention group |
Primary outcome
improved contraceptive uptake
Time frame: March 3, 2021
the contraceptive utilization rate will be increased after the initiation of the intervention
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 3 Mar 2023.
- Derived from this study: PubMed 38917099Muluneh AA, Gedefaw A, Kelaye T, Sisay F, Worku M, Astatkie A, Shiferaw S. Addressing a missed opportunity for contraceptive use during the extended postpartum period by integrating it with infant immunization services in Sidama Region, Ethiopia: A quasi-experimental study. PLOS Glob Public Health. 2024 Jun 25;4(6):e0003236. doi: 10.1371/journal.pgph.0003236. eCollection 2024.
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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.
Abebaw Abeje Muluneh, MSc principal investigator
Hawassa University
Abel Gedefaw, MD, MPh study chair
Hawassa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Hawassa University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. 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?
improved contraceptive uptake (time frame: March 3, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767139, which also lists 1 linked publication.
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 3 Mar 2023.