Contraceptive UsageNCT04780243
Expanded Program for Immunization, a Missed Opportunity for Postpartum Family Planning Utilization
A study testing counseling in people with Contraceptive Usage, run by Hawassa University at 1 site in Ethiopia.
Trial summary
This study is aimed to enhance postpartum family planning by integrating family planning information with infant immunization services, which is the most widely utilized health services globally. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- counseling
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,474 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Feb 2020to 17 Mar 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all women visiting health facilities for infant immunization for at least two times will be included.
Who cannot join
- Women who are in difficulty of communicating during the study period will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Postpartum Family Planning Utilization Through Integration With Expanded Program for Immunization in Sidama, South Ethiopia: A Quasi Experimental Study
This study is aimed to enhance postpartum family planning by integrating family planning information with infant immunization services, which is the most widely utilized health services globally.
Read the detailed description
In this study, a before-and-after type of quasi-experimental study will be conducted in purposely selected health centers Sidama region, Ethiopia. base line assessment of postpartum contraceptive utilization rate will be done which will be followed by an intervention. The intervention consists of screening, counseling for family planning and referring mothers coming for infant immunization services to family planning units. All mothers coming for infant immunization service will be screened for and counseled for family planning and those who will be voluntary to take any method will be referred to family planning unit. All mothers who will not be voluntary will be re-counseled by the next visit.
Finally, the effect of this intervention on postpartum contraceptive utilization rate will be reassessed. The expected outcome will be to see an improved contraceptive uptake during the first year after delivery.
- Conditions
- Contraceptive Usage
- Being tested
- counseling
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingOther
Mothers presented to infant immunization units are going to be counseled for family planning services and if decide to take any method, they will be linked to family planning services
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention group | No intervention | Pre-intervention group: women participated during the base line assessment will be labeled as Pre-intervention group |
| postintervention group | Experimental | Postintervention group: women participated after the intervention was initiated will be labeled as postintervention group. Receives: Other: counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
After the initiation of the intervention, improved Contraceptive prevalence rate will be expected as an outcome
After counseling of the postpartum mothers for family planning, their informed decision making capacity to use contraceptives will be increased.
Measured: the outcome is measured two months after the initiation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Feb 2020
- Primary completion30 Aug 2020
- Study completion17 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawassa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abebaw Abeje Muluneh, Hawassa University
- Investigators
- Abebaw Muluneh, Principal investigator, Hawassa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780243
- Sponsor's protocol ID
- abe16muluneh
- Status last verified
- Mar 2021
- First submitted
- 30 Jan 2021
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Postpartum Family Planning Utilization Through Integration With Expanded Program for Immunization in Sidama, South Ethiopia: A Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT04780243
- Acronym / sponsor ID
- abe16muluneh
- Conditions
- Contraceptive Usage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,474 participants (estimated)
- Lead sponsor
- Hawassa UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 17 Mar 2021 (estimated)
- First posted
- 3 Mar 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.
This study is aimed to enhance postpartum family planning by integrating family planning information with infant immunization services, which is the most widely utilized health services globally.
Detailed description
In this study, a before-and-after type of quasi-experimental study will be conducted in purposely selected health centers Sidama region, Ethiopia. base line assessment of postpartum contraceptive utilization rate will be done which will be followed by an intervention. The intervention consists of screening, counseling for family planning and referring mothers coming for infant immunization services to family planning units. All mothers coming for infant immunization service will be screened for and counseled for family planning and those who will be voluntary to take any method will be referred to family planning unit. All mothers who will not be voluntary will be re-counseled by the next visit.
Finally, the effect of this intervention on postpartum contraceptive utilization rate will be reassessed. The expected outcome will be to see an improved contraceptive uptake during the first year after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention group | No intervention | –Pre-intervention group: women participated during the base line assessment will be labeled as Pre-intervention group |
| postintervention group | Experimental | Other: counselingPostintervention group: women participated after the intervention was initiated will be labeled as postintervention group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all women visiting health facilities for infant immunization for at least two times will be included.
Key exclusion criteria (1 listed)
- Women who are in difficulty of communicating during the study period will be excluded.
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 |
|---|---|---|
| counselingMothers presented to infant immunization units are going to be counseled for family planning services and if decide to take any method, they will be linked to family planning services | Other | postintervention group |
Primary outcome
After the initiation of the intervention, improved Contraceptive prevalence rate will be expected as an outcome
Time frame: the outcome is measured two months after the initiation of the intervention
After counseling of the postpartum mothers for family planning, their informed decision making capacity to use contraceptives will be increased.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
Abebaw Muluneh principal investigator
Hawassa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling in people with Contraceptive Usage, 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. 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?
Results are not available in the source record.
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?
After the initiation of the intervention, improved Contraceptive prevalence rate will be expected as an outcome (time frame: the outcome is measured two months after the initiation of the intervention). 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 3 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.