Prenatal CareNCT02330887
Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
A study testing Group Antenatal Care and Individual Antenatal Care in people with Prenatal Care, run by Possible at 1 site in Nepal.
Trial summary
In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning. Drawing from similar programs that have been shown to improve maternal and neonatal outcomes, we have designed a group antenatal care program that uses a participatory… 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
- Prenatal Care
- What is being tested?
- Group Antenatal Care and Individual Antenatal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,184 participants
- Where
- 1 siteNepal
- Study dates
- 1 Aug 2014to 10 Jul 2016
- 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
- Female
- Age 15-49 years old
- Resident of 14 village clusters in study site
- Intervention cohort: less than 24 weeks' gestation prior to first group antenatal care session.
Who cannot join
- Intervention cohort: more than 24 weeks' gestation prior to first group antenatal care session.
Trial locations and contacts
1 site in 1 country.
About this study
In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning. Drawing from similar programs that have been shown to improve maternal and neonatal outcomes, we have designed a group antenatal care program that uses a participatory learning and action process to engage women in identifying and solving problems accessing maternity care services and create a supportive social network. We plan to test a group antenatal care program that will change antenatal care in three major ways: 1) conduct care in a group setting with women matched by gestational age, 2) incorporate participatory learning and action, and 3) provide expert and facilitated peer counseling.
Read the detailed description
The group antenatal care intervention aims to improve rates of institutional birth and ANC care completion via improving acceptability of group care, maternal and neonatal health knowledge, self-efficacy, social support, and birth planning.
Objective 1: Assess the effect of group antenatal care on institutional birth rates through a prospective study using community household census data. Secondary outcomes will be completion of basic ANC package; neonatal mortality rate; percentage of preterm births; percentage of stillbirths; and percentage of small-for-gestational age (SGA) births.
- Hypothesis 1: Group ANC will increase institutional birth rates by 5% over one year.
- Hypothesis 2: Group ANC will increase completion of 4 ANC visits by 5% over one year.
- Hypothesis 3: Group ANC will reduce infant mortality rate by 5% over one year.
- Hypothesis 4: Group ANC will reduce the postpartum contraceptive prevalence rate by 5% over one year.
- Hypothesis 5: Group ANC will reduce the stillbirth rate by 5% over one year.
- Hypothesis 6: Group ANC will reduce the perinatal mortality rate 5% over one year.
- Hypothesis 7: Group ANC will reduce the combined infant mortality and stillbirth rate by 5% over one year.
Objective 2: Assess the mechanisms of implementation of group antenatal care through quantitative participant survey measures, qualitative focus group discussions and key informant interviews.
- Hypothesis 1: Group antenatal care will be acceptable to participants and providers, and preferred to individual care.
- Hypothesis 2: Group antenatal care will increase pregnant patients' access to and utilization of delivery services through improved knowledge, self-efficacy, social support and birth planning.
Objective 3: Report on key aspects of the implementation process: costs, human resources, logistics, and fidelity of the group antenatal program to model content and participatory processes.
- Conditions
- Prenatal Care
- Being tested
- Group Antenatal Care, Individual Antenatal Care
- Keywords
- Maternal Mortality, Institutional Birth Rate, Neonatal Mortality Rate, Preterm Birth, Stillbirth, Infant, Small for Gestational Age, Nepal, Implementation Research, Global Health
- Medical subject headings
- Maternal Death, Premature Birth, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Antenatal CareOther
The group antenatal care intervention will match pregnant women by gestational age in the intervention village clusters and assign them to peer group sessions facilitated by local healthcare clinic staff.
Individual Antenatal CareOther
Pregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cohort | Experimental | We will use a cohort of 60 women from intervention village clusters for the group antenatal care intervention. Receives: Other: Group Antenatal Care |
| Control Cohort | Active comparator | We will use a cohort of 60 women from control village clusters as an active comparison. Receives: Other: Individual Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Institutional Birth Rate
We expect the number of pregnant women from intervention village clusters who give birth at a healthcare facility to increase by 5% compared to control.
Measured: 1 year
Secondary outcomes (6)
Infant Mortality Rate
We expect the infant mortality rate to be 5% lower among the babies from the intervention cohort women compared to control.
Measured: 1 year
Postpartum contraceptive prevalence rates
We expect the postpartum contraceptive prevalence rate to be 5% higher among the intervention cohort women compared to control.
Measured: 1 year
Completion percentage of 4 antenatal care visits
We expect that 5% more women in the intervention cohort will complete all 4 antenatal care visits compared to the control.
Measured: 1 year
Stillbirth rate
We expect that the stillbirth rate will be 5% lower among the intervention cohort compared to control.
Measured: 1 year
Perinatal mortality rate
We expect that the perinatal mortality rate will be 5% lower among the intervention cohort compared to control.
Measured: 1 year
Combined infant mortality and stillbirth rate
We expect that the combined infant mortality and stillbirth rate will be 5% lower among the intervention cohort compared to control
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study start1 Aug 2014
- Primary completion10 Jul 2016
- Study completion10 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prenatal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Possible
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- David Citrin, PhD, MPH, Study director, PossibleDuncan Maru, MD, PhD, Principal investigator, PossibleBiraj Karmacharya, MBBS, Msc, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330887
- Sponsor's protocol ID
- GroupANCnyaya
- Status last verified
- Jun 2021
- First submitted
- 31 Dec 2014
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Harsha Bangura A, Nirola I, Thapa P, Citrin D, Belbase B, Bogati B, B K N, Khadka S, Kunwar L, Halliday S, Choudhury N, Schwarz R, Adhikari M, Kalaunee SP, Rising S, Maru D, Maru S. Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal. Reprod Health. 2020 Jan 17;17(1):5. doi: 10.1186/s12978-019-0840-4.
PubMed 31952543Thapa P, Bangura AH, Nirola I, Citrin D, Belbase B, Bogati B, Nirmala BK, Khadka S, Kunwar L, Halliday S, Choudhury N, Ozonoff A, Tenpa J, Schwarz R, Adhikari M, Kalaunee SP, Rising S, Maru D, Maru S. The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal. Reprod Health. 2019 Oct 22;16(1):150. doi: 10.1186/s12978-019-0820-8.
PubMed 31640770
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
- ClinicalTrials.gov ID
- NCT02330887
- Acronym / sponsor ID
- GroupANCnyaya
- Conditions
- Prenatal Care
- Keywords
- Maternal Mortality, Institutional Birth Rate, Neonatal Mortality Rate, Preterm Birth, Stillbirth, Infant, Small for Gestational Age, Nepal, Implementation Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,184 participants (actual)
- Lead sponsor
- PossibleUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 10 Jul 2016 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning. Drawing from similar programs that have been shown to improve maternal and neonatal outcomes, we have designed a group antenatal care program that uses a participatory learning and action process to engage women in identifying and solving problems accessing maternity care services and create a supportive social network. We plan to test a group antenatal care program that will change antenatal care in three major ways: 1) conduct care in a group setting with women matched by gestational age, 2) incorporate participatory learning and action, and 3) provide expert and facilitated peer counseling.
Detailed description
The group antenatal care intervention aims to improve rates of institutional birth and ANC care completion via improving acceptability of group care, maternal and neonatal health knowledge, self-efficacy, social support, and birth planning.
Objective 1: Assess the effect of group antenatal care on institutional birth rates through a prospective study using community household census data. Secondary outcomes will be completion of basic ANC package; neonatal mortality rate; percentage of preterm births; percentage of stillbirths; and percentage of small-for-gestational age (SGA) births.
- Hypothesis 1: Group ANC will increase institutional birth rates by 5% over one year.
- Hypothesis 2: Group ANC will increase completion of 4 ANC visits by 5% over one year.
- Hypothesis 3: Group ANC will reduce infant mortality rate by 5% over one year.
- Hypothesis 4: Group ANC will reduce the postpartum contraceptive prevalence rate by 5% over one year.
- Hypothesis 5: Group ANC will reduce the stillbirth rate by 5% over one year.
- Hypothesis 6: Group ANC will reduce the perinatal mortality rate 5% over one year.
- Hypothesis 7: Group ANC will reduce the combined infant mortality and stillbirth rate by 5% over one year.
Objective 2: Assess the mechanisms of implementation of group antenatal care through quantitative participant survey measures, qualitative focus group discussions and key informant interviews.
- Hypothesis 1: Group antenatal care will be acceptable to participants and providers, and preferred to individual care.
- Hypothesis 2: Group antenatal care will increase pregnant patients' access to and utilization of delivery services through improved knowledge, self-efficacy, social support and birth planning.
Objective 3: Report on key aspects of the implementation process: costs, human resources, logistics, and fidelity of the group antenatal program to model content and participatory processes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort | Experimental | Other: Group Antenatal CareWe will use a cohort of 60 women from intervention village clusters for the group antenatal care intervention. |
| Control Cohort | Active comparator | Other: Individual Antenatal CareWe will use a cohort of 60 women from control village clusters as an active comparison. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female
- Age 15-49 years old
- Resident of 14 village clusters in study site
- Intervention cohort: less than 24 weeks' gestation prior to first group antenatal care session.
Key exclusion criteria (1 listed)
- Intervention cohort: more than 24 weeks' gestation prior to first group antenatal care session.
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 CareThe group antenatal care intervention will match pregnant women by gestational age in the intervention village clusters and assign them to peer group sessions facilitated by local healthcare clinic staff. | Other | Intervention Cohort |
| Individual Antenatal CarePregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider. | Other | Control Cohort |
Primary outcome
Institutional Birth Rate
Time frame: 1 year
We expect the number of pregnant women from intervention village clusters who give birth at a healthcare facility to increase by 5% compared to control.
6 secondary outcomes
Infant Mortality Rate
Time frame: 1 year
Postpartum contraceptive prevalence rates
Time frame: 1 year
Completion percentage of 4 antenatal care visits
Time frame: 1 year
Stillbirth rate
Time frame: 1 year
Perinatal mortality rate
Time frame: 1 year
Combined infant mortality and stillbirth rate
Time frame: 1 year
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 25 Jun 2021.
- Derived from this study: PubMed 31952543Harsha Bangura A, Nirola I, Thapa P, Citrin D, Belbase B, Bogati B, B K N, Khadka S, Kunwar L, Halliday S, Choudhury N, Schwarz R, Adhikari M, Kalaunee SP, Rising S, Maru D, Maru S. Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal. Reprod Health. 2020 Jan 17;17(1):5. doi: 10.1186/s12978-019-0840-4.
- Derived from this study: PubMed 31640770Thapa P, Bangura AH, Nirola I, Citrin D, Belbase B, Bogati B, Nirmala BK, Khadka S, Kunwar L, Halliday S, Choudhury N, Ozonoff A, Tenpa J, Schwarz R, Adhikari M, Kalaunee SP, Rising S, Maru D, Maru S. The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal. Reprod Health. 2019 Oct 22;16(1):150. doi: 10.1186/s12978-019-0820-8.
- PossibleLink provided by the sponsor.
- Healthcare Systems Design GroupLink provided by the sponsor.
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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.
David Citrin, PhD, MPH study director
Possible
Duncan Maru, MD, PhD principal investigator
Possible
Biraj Karmacharya, MBBS, Msc study chair
University of Washington
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 and Individual Antenatal Care in people with Prenatal Care, run by Possible at 1 site in Nepal.
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 4 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 25 Jun 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 Nepal. 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?
Institutional Birth Rate (time frame: 1 year). 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 NCT02330887, which also lists 2 linked publications.
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 25 Jun 2021.