Antenatal CareARC004NCT05054491
Ethiopia Group Antenatal Care Study at the Health Post Level
A study testing Group Antenatal Care in people with Antenatal Care, run by Jhpiego at 1 site in Ethiopia.
Trial summary
The purpose of this study is to determine the acceptability, feasibility, and effectiveness of a group antenatal care (G-ANC) model introduced at the health post level compared to usual antenatal care (ANC) among women who report intention to receive ANC at the health post level. 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
- Antenatal Care
- What is being tested?
- Group Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteEthiopia
- Study dates
- 20 Sep 2021to 28 Feb 2024
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Minimum age of 15 years at the time of enrollment; pregnant 15-17 year-olds will be treated as emancipated/mature as per local regulations
- Gestational age less than or equal to 20 weeks at the time of enrollment determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test
- Pregnant women able and willing to provide adequate locator information
- Planning to reside at their current location for at least 10 months
- Agree to participate in the study and continue ANC at health post
- Willing to participate and consent to follow up for up to 6 weeks post-delivery
- Are willing to receive group antenatal care at the health post level (during the intervention period)
Who cannot join
- Women who plan to travel away from the study site for more than four consecutive weeks during ANC or after 6 weeks post-delivery
- Women who are unable provide consent
- Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Enashenifalen
Mecha, North Mecha Woreda, West Gojam Zone, Amhara Region
About this study
Official title: Evaluation of the Feasibility, Acceptability and Impact of Group-based Antenatal Care at the Health Post Level on Continuation in Antenatal Care and Facility-based Delivery in Amhara, Ethiopia Using a Cluster Randomized Step-wedge Design
The purpose of this study is to determine the acceptability, feasibility, and effectiveness of a group antenatal care (G-ANC) model introduced at the health post level compared to usual antenatal care (ANC) among women who report intention to receive ANC at the health post level.
- Conditions
- Antenatal Care
- Being tested
- Group Antenatal Care
- Keywords
- Ethiopia, Health post, Group ANC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Antenatal CareBehavioural
Group ANC is an integrated approach that incorporates physical assessment, education and skill development, and peer support and takes a broader, more holistic, woman-centered approach to traditional antenatal care
| Study group | Role | What they receive |
|---|---|---|
| Group ANC | Experimental | Intervention period in stepped wedge design where women are receiving antenatal care in a group setting Receives: Behavioral: Group Antenatal Care |
| Individual ANC (routine) | No intervention | Pre-intervention time period (control period) where the intervention is not being implemented yet (women are receiving individual antenatal care as is currently offered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of G-ANC at the health post level
Satisfaction survey to understand satisfaction with G-ANC
Measured: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Feasibility of G-ANC at the health post level
Documentation of number of G-ANC sessions facilitated by by health extension workers to measure feasibility
Measured: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Effectiveness of G-ANC on continuation of ANC
Survey of self-reported number of ANC visits to document effectiveness of continuing ANC
Measured: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Secondary outcomes (1)
Effectiveness of G-ANC on quality of care
Survey of self-reported quality of care elements received during ANC to understand role of G-ANC on improving elements of quality of care during ANC
Measured: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start20 Sep 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: We are not able to continue the study as there is conflict in the study area that prevents women from gathering for group antenatal care. It is also not safe for data collectors to collect data in the study sites.
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 Antenatal CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge design
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Addis Continental Institute of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054491
- Sponsor's protocol ID
- 14448
- Acronym
- ARC004
- Status last verified
- Apr 2024
- First submitted
- 11 Aug 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with the Gates ARC partner, RTI
Publications
Yallew WW, Fasil R, Berhanu D, Wolde K, Teshite D, Sethi R, Yenokyan G, Woldemariam Y, Suhowatsky S, Hyre A, Noguchi L, Worku A. Evaluation of the feasibility, acceptability, and impact of Group Antenatal Care at the health post level on continuation in antenatal care and facility based delivery in Ethiopia using a cluster randomized stepped-wedge design: Study protocol. Gates Open Res. 2025 Jan 31;8:29. doi: 10.12688/gatesopenres.15190.3. eCollection 2024.
PubMed 39936142
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility, Acceptability and Impact of Group-based Antenatal Care at the Health Post Level on Continuation in Antenatal Care and Facility-based Delivery in Amhara, Ethiopia Using a Cluster Randomized Step-wedge Design
- ClinicalTrials.gov ID
- NCT05054491
- Acronym / sponsor ID
- ARC004 / 14448
- Conditions
- Antenatal Care
- Keywords
- Ethiopia, Health post, Group ANC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We are not able to continue the study as there is conflict in the study area that prevents women from gathering for group antenatal care. It is also not safe for data collectors to collect data in the study sites.
- Enrolment
- 540 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Addis Continental Institute of Public Health
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 23 Sep 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 purpose of this study is to determine the acceptability, feasibility, and effectiveness of a group antenatal care (G-ANC) model introduced at the health post level compared to usual antenatal care (ANC) among women who report intention to receive ANC at the health post level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Group ANC | Experimental | Behavioral: Group Antenatal CareIntervention period in stepped wedge design where women are receiving antenatal care in a group setting |
| Individual ANC (routine) | No intervention | –Pre-intervention time period (control period) where the intervention is not being implemented yet (women are receiving individual antenatal care as is currently offered) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Minimum age of 15 years at the time of enrollment; pregnant 15-17 year-olds will be treated as emancipated/mature as per local regulations
- Gestational age less than or equal to 20 weeks at the time of enrollment determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test
- Pregnant women able and willing to provide adequate locator information
- Planning to reside at their current location for at least 10 months
- Agree to participate in the study and continue ANC at health post
Key exclusion criteria (3 listed)
- Women who plan to travel away from the study site for more than four consecutive weeks during ANC or after 6 weeks post-delivery
- Women who are unable provide consent
- Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
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 |
|---|---|---|
| Group Antenatal CareGroup ANC is an integrated approach that incorporates physical assessment, education and skill development, and peer support and takes a broader, more holistic, woman-centered approach to traditional antenatal care | Behavioural | Group ANC |
Primary outcome
Acceptability of G-ANC at the health post level
Time frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Satisfaction survey to understand satisfaction with G-ANC
Feasibility of G-ANC at the health post level
Time frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Documentation of number of G-ANC sessions facilitated by by health extension workers to measure feasibility
Effectiveness of G-ANC on continuation of ANC
Time frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Survey of self-reported number of ANC visits to document effectiveness of continuing ANC
1 secondary outcome
Effectiveness of G-ANC on quality of care
Time frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Results and safety
The study was stopped early (reason given: We are not able to continue the study as there is conflict in the study area that prevents women from gathering for group antenatal care. It is also not safe for data collectors to collect data in the study sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 39936142Yallew WW, Fasil R, Berhanu D, Wolde K, Teshite D, Sethi R, Yenokyan G, Woldemariam Y, Suhowatsky S, Hyre A, Noguchi L, Worku A. Evaluation of the feasibility, acceptability, and impact of Group Antenatal Care at the health post level on continuation in antenatal care and facility based delivery in Ethiopia using a cluster randomized stepped-wedge design: Study protocol. Gates Open Res. 2025 Jan 31;8:29. doi: 10.12688/gatesopenres.15190.3. eCollection 2024.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with the Gates ARC partner, RTI
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Antenatal Care in people with Antenatal Care, run by Jhpiego 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Apr 2024. 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 was stopped early (reason given: We are not able to continue the study as there is conflict in the study area that prevents women from gathering for group antenatal care. It is also not safe for data collectors to collect data in the study sites.). 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?
Acceptability of G-ANC at the health post level (time frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery). The study lists 3 primary outcomes in all. 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 NCT05054491, 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 2 Apr 2024.