Health SystemsC-it-DU-itNCT05929586
Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.
A study testing The combined "C-it DU-it" intervention: community data use for ANC in people with Health Systems and Electronic Community Health Information Systems, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
Trial summary
The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Systems, Electronic Community Health Information Systems, Antenatal Clinic Uptake
- What is being tested?
- The combined "C-it DU-it" intervention: community data use for ANC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteKenya
- Study dates
- 29 Nov 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pregnant women of all ages willing to participate
- Written informed consent
- A resident of the study area (catchment area) for the duration of the pregnancy
- Delivered and still within the 6-week post-partum period.
Who cannot join
- Currently enrolled in another interventional study targeting pregnant women
- Outside the 6-week post-partum period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
KEMRI Centre for Global Health Research
Homa Bay
Gerald N Ong'ayo, MD, +254737491526, gerald.ongayo@lstmed.ac.uk
About this study
Official title: A Pragmatic Open-label, Community-based, Cluster Randomised Controlled Superiority Trial to Evaluate the Efficacy and Cost-effectiveness of Digital Data Linkage and Scheduling ('C-it') With or Without Community Data Use ('DU-it') to Increase Antenatal Clinic Uptake in Western Kenya.
The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).
Read the detailed description
Facility and community health data is being rapidly digitised using multiple parallel systems across the 47 devolved counties in Kenya, but data do not link. Setting up community-based antenatal care (ANC) to complement facility-based ANC and data systems that link these platforms is essential to support Kenya in adopting WHO's ambitious target of 8 ANC contacts. As of February 2023, national scale up of the national electronic community health information systems (eCHIS) for standard of care is ongoing, and there are increased efforts to scale-up use of the nationally approved Kenya Electronic Medical Records (KenyaEMR) Maternal and Child Health Module (MNH) to capture ANC, delivery and postnatal (PNC) data at health facilities. Data between eCHIS and Kenya EMR do not link. There are plans within the Community Health Division at national level to link eCHIS to facility EMRs, but this has yet to be developed. The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. The short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The overarching research question the investigators will seek to answer is "what is the effect of 'C-it DU it' on community health systems strengthening and what is required for effective transfer and scale-up?" The investigators will use mixed methods implementation research to evaluate this in 4 counties in Western Kenya (Homa Bay, Migori, Kisumu, Kakamega) over a period of four years. The proposed methods include: (a) Realist evaluation to generate, empirically test and refine a transferrable programme theory to understand the causal relationship between context, participant response and outcomes; (b) A 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm); (c) Health economic evaluation and equity analysis to compare costs and catastrophic health expenditure of women accessing and engaging with ANC care and determine costs and cost-effectiveness of C-it Du-it from a health systems perspective; and (d) Qualitative interviews will assess transferability and iterative scale-up of C-it DU-it across the three remaining counties using toolkits developed in Homa Bay. This protocol describes the pragmatic cluster randomised trial and health economic evaluation. The realist evaluation and scale up will be addressed in a separate sister protocol.
- Conditions
- Health Systems, Electronic Community Health Information Systems, Antenatal Clinic Uptake, Pregnancy
- Being tested
- The combined "C-it DU-it" intervention: community data use for ANC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The combined "C-it DU-it" intervention: community data use for ANCOther
Also called community data use (DU-it)
Combining data linkage ("C-it") with work improvement teams for community data use ("DU-it") to improve antenatal clinic uptake. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it)
| Study group | Role | What they receive |
|---|---|---|
| Digital data linkage and scheduling ('C-it'): The "C-it" enhanced standard of care | No intervention | Linking facility to community digital data via linkage-app: Data between electronic Community Health Information System (eCHIS) and facility-based Kenya Electronic Medical Record (Kenya EMR) do not link. We do not have an existing digital data linkage module or app to track successful pregnancy referrals or allow the facility staff to view community contacts and vice versa. We will engage with national and county teams and software developers to build a digital data linkage module, linking eCHIS and Kenya EMR Maternal and Child Health (MCH) module. |
| The combined "C-it DU-it" intervention: community data use for ANC | Experimental | Combining "C-it" and work improvement teams (WITs) for community data use: We will establish and train integrated WITs in intervention sites consisting of community health members, health facility staff and community members and train them on how they will use linkage-app. The resultant combined "C-it DU-it" intervention has three building blocks:
We make the following assumptions about the building blocks at the bottom of figure 1.
1. Building block 1: We assume that high-quality digital data that can trace the entire journey through pregnancy is accessible to CHVs
2. Building block 2: We also assume that integrated work improvement teams (WITs) will have the right people around the table with clearly defined roles and responsibilities will use the data.
3. Building block 3: Community ANC contacts will be implemented. Receives: Other: The combined "C-it DU-it" intervention: community data use for ANC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing antenatal clinic uptake
The proportion of women having at least eight ANC contacts during the antenatal period, defined as either a scheduled ANC visit in the facility or a scheduled ANC contact with a CHV in the community assessed at birth (or within the first 6-8 weeks for home births) using the ANC cards.
Measured: 14 months
Estimate socioeconomic impact and access to social protection
Defined as the proportion of women using financial coping strategies and their frequency and distribution
Measured: 14 months
Estimate the costs to pregnant women and their households
Absolute costs to the pregnant woman and their household and the costs as a proportion of the pregnant woman and their household's monthly income or expenditure/consumption will be calculated for the following variables:
- Out-of-pocket medical costs
- Out-of-pocket non-medical costs
- Lost income, time, and productivity
Measured: 14 months
Secondary outcomes (11)
The proportion of women having at least four scheduled ANC visits in the facility
assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
Measured: 14 months
The proportion of women having at least eight scheduled ANC visits in the facility
assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
Measured: 14 months
The frequency (count) of scheduled ANC visits
assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
Measured: 14 months
The frequency (count) of of ANC visits in the community
assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
Measured: 14 months
Early antenatal clinic attendance
The proportion of women with a first ANC contact before 16 weeks gestation.
Measured: 14 months
Quality of antenatal care
- The proportion of women with at least three courses of IPTp
- The proportion of women who received iron and folate for 90 days.
- The proportion of women receiving testing and management for HIV.
- The proportion of women receiving testing and management for malaria.
- The proportion of women receiving testing and management for syphilis.
- The proportion of women receiving testing and management for anaemia.
Measured: 14 months
Uptake of skilled birth attendance.
The proportion of women who had a skilled birth attendance.
Measured: 14 months
Reducing the risk of adverse pregnancy outcomes.
The proportion of women with adverse pregnancy outcomes- defined as a composite of foetal loss (stillbirth or spontaneous miscarriage), low birth weight or neonatal mortality)
Measured: 14 months
prevalence of catastrophic health expenditure (CHE) of accessing ANC care with "C-it" enhanced standard of care
CHE prevalence at two World Health Organization-defined thresholds: out-of-pocket medical costs of more than 10% of a patient household's total monthly expenditure/consumption (10%-threshold); and out-of-pocket medical costs of more than 40% of a patient household's monthly capacity to pay (non-food/housing/utilities expenditure/consumption)
- A sensitivity analysis of the proportion of women's households incurring CHE due to pregnancy and ANC visits using varying additional recognised calculations and thresholds including, as per WHO Tuberculosis Patient Cost Survey methodology, the addition of non-medical out-of-pocket costs and lost income in the numerator
Measured: 14 months
Cost-effectiveness of "C-it" and "C-it DU-it" intervention
Incremental cost-effectiveness ratios (ICERs) compared across trial arms
Measured: 14 months
Assess equity of access to ANC and "C-it" and "C-it DU-it" intervention.
Equity of access to ANC and the interventions will be evaluated by exploratory distributional (or "extended") cost-effectiveness analysis of the intervention across the following sub-groups: poverty quintiles, age groups including adolescents vs adults, study sites, HIV status, and by eligibility for health insurance including NHIF and Linda Mama.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start29 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 Health SystemsStudies 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
- Parallel groups
- Model description
- Allocation: cluster randomised; intervention model: parallel assignment; arms: 2; allocation ratio: 1:1; restricted or stratified randomisation. Masking: none
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, LVCT Health
- Responsible party
- Sponsor
- Investigators
- Miriam Taegtmeyer, PhD, Principal investigator, Liverpool School of Tropical MedicineTom Wingfield, PhD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929586
- Sponsor's protocol ID
- 22-073
- Acronym
- C-it-DU-it
- Status last verified
- Jun 2025
- First submitted
- 5 Apr 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via data transfer agreements with the collaborating institutions to minimise the risk of unauthorised analysis beyond the scope of the agreed parameters. The full protocol will be available on request to any interested professional and may be published in a peer-reviewed journal or deposited in an online repository. Individual, de-identified participant data will be made available for meta-analyses as soon as the data analysis is completed, with the understanding that the meta-analysis results will not be published before the individual trial results without the prior agreement of the investigators. The de-identified data set of the complete participant-level data will be available for sharing purposes. A Data Access Committee will consider all requests for data for secondary analysis to ensure that the use of data is within the terms of consent and ethics approval and in line with the Kenya Data Protection Act 2019.
Publications
Ong'ayo G, Barsosio HC, Otiso L, Kamau A, Dodd J, Okoth L, Oguche M, Doyle V, Ochodo E, Okomo G, Ter Kuile F, Taegtmeyer M. Evaluating community digital data linkage with or without community data use to increase antenatal care uptake in Western Kenya: protocol for a pragmatic open-label, cluster-randomised controlled superiority trial. Front Health Serv. 2026 Jan 27;5:1697161. doi: 10.3389/frhs.2025.1697161. eCollection 2025.
PubMed 41675597
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Open-label, Community-based, Cluster Randomised Controlled Superiority Trial to Evaluate the Efficacy and Cost-effectiveness of Digital Data Linkage and Scheduling ('C-it') With or Without Community Data Use ('DU-it') to Increase Antenatal Clinic Uptake in Western Kenya.
- ClinicalTrials.gov ID
- NCT05929586
- Acronym / sponsor ID
- C-it-DU-it / 22-073
- Conditions
- Health Systems, Electronic Community Health Information Systems, Antenatal Clinic Uptake, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, LVCT Health
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Jul 2023 (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 investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).
Detailed description
Facility and community health data is being rapidly digitised using multiple parallel systems across the 47 devolved counties in Kenya, but data do not link. Setting up community-based antenatal care (ANC) to complement facility-based ANC and data systems that link these platforms is essential to support Kenya in adopting WHO's ambitious target of 8 ANC contacts. As of February 2023, national scale up of the national electronic community health information systems (eCHIS) for standard of care is ongoing, and there are increased efforts to scale-up use of the nationally approved Kenya Electronic Medical Records (KenyaEMR) Maternal and Child Health Module (MNH) to capture ANC, delivery and postnatal (PNC) data at health facilities. Data between eCHIS and Kenya EMR do not link. There are plans within the Community Health Division at national level to link eCHIS to facility EMRs, but this has yet to be developed. The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. The short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The overarching research question the investigators will seek to answer is "what is the effect of 'C-it DU it' on community health systems strengthening and what is required for effective transfer and scale-up?" The investigators will use mixed methods implementation research to evaluate this in 4 counties in Western Kenya (Homa Bay, Migori, Kisumu, Kakamega) over a period of four years. The proposed methods include: (a) Realist evaluation to generate, empirically test and refine a transferrable programme theory to understand the causal relationship between context, participant response and outcomes; (b) A 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm); (c) Health economic evaluation and equity analysis to compare costs and catastrophic health expenditure of women accessing and engaging with ANC care and determine costs and cost-effectiveness of C-it Du-it from a health systems perspective; and (d) Qualitative interviews will assess transferability and iterative scale-up of C-it DU-it across the three remaining counties using toolkits developed in Homa Bay. This protocol describes the pragmatic cluster randomised trial and health economic evaluation. The realist evaluation and scale up will be addressed in a separate sister protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation: cluster randomised; intervention model: parallel assignment; arms: 2; allocation ratio: 1:1; restricted or stratified randomisation. Masking: none
| Arm | Type | Receives |
|---|---|---|
| Digital data linkage and scheduling ('C-it'): The "C-it" enhanced standard of care | No intervention | –Linking facility to community digital data via linkage-app: Data between electronic Community Health Information System (eCHIS) and facility-based Kenya Electronic Medical Record (Kenya EMR) do not link. We do not have an existing digital data linkage module or app to track successful pregnancy referrals or allow the facility staff to view community contacts and vice versa. We will engage with national and county teams and software developers to build a digital data linkage module, linking eCHIS and Kenya EMR Maternal and Child Health (MCH) module. |
| The combined "C-it DU-it" intervention: community data use for ANC | Experimental | Other: The combined "C-it DU-it" intervention: community data use for ANCCombining "C-it" and work improvement teams (WITs) for community data use: We will establish and train integrated WITs in intervention sites consisting of community health members, health facility staff and community members and train them on how they will use linkage-app. The resultant combined "C-it DU-it" intervention has three building blocks: We make the following assumptions about the building blocks at the bottom of figure 1. 1. Building block 1: We assume that high-quality digital data that can trace the entire journey through pregnancy is accessible to CHVs 2. Building block 2: We also assume that integrated work improvement teams (WITs) will have the right people around the table with clearly defined roles and responsibilities will use the data. 3. Building block 3: Community ANC contacts will be implemented. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women of all ages willing to participate
- Written informed consent
- A resident of the study area (catchment area) for the duration of the pregnancy
- Delivered and still within the 6-week post-partum period.
Key exclusion criteria (2 listed)
- Currently enrolled in another interventional study targeting pregnant women
- Outside the 6-week post-partum period.
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 |
|---|---|---|
| The combined "C-it DU-it" intervention: community data use for ANCAlso: community data use (DU-it)Combining data linkage ("C-it") with work improvement teams for community data use ("DU-it") to improve antenatal clinic uptake. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it) | Other | The combined "C-it DU-it" intervention: community data use for ANC |
Primary outcome
Increasing antenatal clinic uptake
Time frame: 14 months
The proportion of women having at least eight ANC contacts during the antenatal period, defined as either a scheduled ANC visit in the facility or a scheduled ANC contact with a CHV in the community assessed at birth (or within the first 6-8 weeks for home births) using the ANC cards.
Estimate socioeconomic impact and access to social protection
Time frame: 14 months
Defined as the proportion of women using financial coping strategies and their frequency and distribution
Estimate the costs to pregnant women and their households
Time frame: 14 months
Absolute costs to the pregnant woman and their household and the costs as a proportion of the pregnant woman and their household's monthly income or expenditure/consumption will be calculated for the following variables: * Out-of-pocket medical costs * Out-of-pocket non-medical costs * Lost income, time, and productivity
11 secondary outcomes
The proportion of women having at least four scheduled ANC visits in the facility
Time frame: 14 months
The proportion of women having at least eight scheduled ANC visits in the facility
Time frame: 14 months
The frequency (count) of scheduled ANC visits
Time frame: 14 months
The frequency (count) of of ANC visits in the community
Time frame: 14 months
Early antenatal clinic attendance
Time frame: 14 months
Quality of antenatal care
Time frame: 14 months
Uptake of skilled birth attendance.
Time frame: 14 months
Reducing the risk of adverse pregnancy outcomes.
Time frame: 14 months
prevalence of catastrophic health expenditure (CHE) of accessing ANC care with "C-it" enhanced standard of care
Time frame: 14 months
Cost-effectiveness of "C-it" and "C-it DU-it" intervention
Time frame: 14 months
Assess equity of access to ANC and "C-it" and "C-it DU-it" intervention.
Time frame: 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 41675597Ong'ayo G, Barsosio HC, Otiso L, Kamau A, Dodd J, Okoth L, Oguche M, Doyle V, Ochodo E, Okomo G, Ter Kuile F, Taegtmeyer M. Evaluating community digital data linkage with or without community data use to increase antenatal care uptake in Western Kenya: protocol for a pragmatic open-label, cluster-randomised controlled superiority trial. Front Health Serv. 2026 Jan 27;5:1697161. doi: 10.3389/frhs.2025.1697161. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data will be shared via data transfer agreements with the collaborating institutions to minimise the risk of unauthorised analysis beyond the scope of the agreed parameters. The full protocol will be available on request to any interested professional and may be published in a peer-reviewed journal or deposited in an online repository. Individual, de-identified participant data will be made available for meta-analyses as soon as the data analysis is completed, with the understanding that the meta-analysis results will not be published before the individual trial results without the prior agreement of the investigators. The de-identified data set of the complete participant-level data will be available for sharing purposes. A Data Access Committee will consider all requests for data for secondary analysis to ensure that the use of data is within the terms of consent and ethics approval and in line with the Kenya Data Protection Act 2019.
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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.
Miriam Taegtmeyer, PhD principal investigator
Liverpool School of Tropical Medicine
Tom Wingfield, PhD principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The combined "C-it DU-it" intervention: community data use for ANC in people with Health Systems and Electronic Community Health Information Systems, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
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 2 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. 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 Kenya. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hellen C Barsosio, MD (+254724464507, hbarsosio@kemri.go.ke), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing antenatal clinic uptake (time frame: 14 months). 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 NCT05929586, 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 27 Jun 2025.