Pregnant WomenNCT06654505
Can Village Health Volunteers/Workers Working As Male-Female Pairs Improve the Use of Postnatal Care Services in the Lao People's Democratic Republic
A study testing Paired Community Health Workers in people with Pregnant Women and Lactating Mother, run by University of the Ryukyus at 1 site in Laos.
Trial summary
The study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR. Methods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Pregnant Women, Lactating Mother
- What is being tested?
- Paired Community Health Workers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteLaos
- Study dates
- 10 Aug 2024to 31 Oct 2026
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women who gave birth within six weeks and twelve months before the study's baseline and end-line surveys.
Who cannot join
- Women whose births resulted in a loss,
- Women who do consent to participate in the surveys
- Women who face a language barrier with surveyors will not be enrolled.
Trial locations and contacts
1 site in 1 country.
Laos1 site, 1 recruiting
- Recruiting
Sepon and Vilabouly districts
Savannakhet
Tiengkham PONGVONGSA, +8562055640403, tiengkhampvs@gmail.com
About this study
Official title: Effectiveness of Village Health Volunteers/Workers Working As Male-Female Pairs on Women's Use of Postnatal Care Services in Sepone District in Lao People's Democratic Republic: a Protocol for a Quasi-experimental Cluster Study
The study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR.
Methods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. In 19 selected intervention villages in the Sepone district, female-male VHV/Ws pairs will promote postpartum services, whereas, in 18 similar control villages in the Vilabuly district, VHV/Ws will work as individuals.
- Conditions
- Pregnant Women, Lactating Mother
- Being tested
- Paired Community Health Workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired Community Health WorkersBehavioural
Community Health Workers will promote maternal and child health services as paired female and male
| Study group | Role | What they receive |
|---|---|---|
| Villages where Village Health Volunteers/Workers work as individuals | No intervention | Not described |
| Villages where Community Health Workers work in pairs | Experimental | Not described Receives: Behavioral: Paired Community Health Workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of second postnatal care visit
Second postnatal visit within 6 weeks after delivery in a health facility reported in maternal and child health handbook
Measured: 6 weeks after delivery
Secondary outcomes (1)
Lenght of facility-based postpartum stay
Number of hours of stay in health facility after delivery
Measured: cutoff is 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start10 Aug 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Ryukyus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Credo Adelphe Ahissou, University of the Ryukyus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654505
- Sponsor's protocol ID
- 24-2329-00-00-00
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Village Health Volunteers/Workers Working As Male-Female Pairs on Women's Use of Postnatal Care Services in Sepone District in Lao People's Democratic Republic: a Protocol for a Quasi-experimental Cluster Study
- ClinicalTrials.gov ID
- NCT06654505
- Acronym / sponsor ID
- 24-2329-00-00-00
- Conditions
- Pregnant Women, Lactating Mother
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- University of the RyukyusUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 23 Oct 2024 (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 study aims to assess the effectiveness of male-female VHV/Ws working in pairs on women's uptake of second PNC visits in rural Sepone, Lao PDR.
Methods A quasi-experimental cluster study will be conducted between July 2024 and October 2026 in 37 selected sites from two districts in southern Lao PDR. In 19 selected intervention villages in the Sepone district, female-male VHV/Ws pairs will promote postpartum services, whereas, in 18 similar control villages in the Vilabuly district, VHV/Ws will work as individuals.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Villages where Village Health Volunteers/Workers work as individuals | No intervention | – |
| Villages where Community Health Workers work in pairs | Experimental | Behavioral: Paired Community Health Workers |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women who gave birth within six weeks and twelve months before the study's baseline and end-line surveys.
Key exclusion criteria (3 listed)
- Women whose births resulted in a loss,
- Women who do consent to participate in the surveys
- Women who face a language barrier with surveyors will not be enrolled.
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 |
|---|---|---|
| Paired Community Health WorkersCommunity Health Workers will promote maternal and child health services as paired female and male | Behavioural | Villages where Community Health Workers work in pairs |
Primary outcome
Uptake of second postnatal care visit
Time frame: 6 weeks after delivery
Second postnatal visit within 6 weeks after delivery in a health facility reported in maternal and child health handbook
1 secondary outcome
Lenght of facility-based postpartum stay
Time frame: cutoff is 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paired Community Health Workers in people with Pregnant Women and Lactating Mother, run by University of the Ryukyus at 1 site in Laos.
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 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: status not confirmed, as of the sponsor's last update on 28 Oct 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 Laos. 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?
Contact Credo Ahissou, PhD (+818064827518, Adelphahiss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of second postnatal care visit (time frame: 6 weeks after delivery). 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 28 Oct 2024.