Stitch and hormone combo may stop preterm birth
NCT ID NCT06463652
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study compares two approaches to prevent preterm birth in pregnant women with a short cervix: a cervical stitch (cerclage) plus vaginal progesterone versus progesterone alone. About 328 women with a singleton pregnancy and a cervix shorter than 25 mm will be randomly assigned to one of the two groups. The main goal is to see which method delays delivery longer and improves newborn health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vaginal progesterone (Cyclogest 200 mg)
- What this could lead to
- If successful, this could establish a more effective way to prevent preterm birth in women with a short cervix, reducing risks for both mother and baby.
- What could go wrong
- This is a single-center trial, so results may not apply to all populations. The procedure (cerclage) carries risks like infection or membrane rupture, and the benefit over progesterone alone is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 328 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Maternal age ≥18 years * Singleton pregnancy * Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7 - 24 0/7 weeks of gestation) * Not participating in any other study which has intervention on maternity or fetus * Provision of written informed consent as shown by a signature on the participant consent form. Exclusion Criteria: * Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina * Major congenital abnormalities of the fetus * Intrauterine fetal demise * Presence of severe vaginal discharge\* * Presence of vaginitis or cervicitis\* * Presence of vaginal bleeding\* * Placenta previa or vasa previa * Preterm premature rupture of membranes * Preterm labor without ruptured membrane at the time of screening * Suspected chorioamnionitis * Unable to undergo cerclage * Cerclage in place * Allergy to progesterone (\*Women with acute cervicitis, vaginitis or severe vaginal discharge are eligible once they have been treated and if they have a CL ≤25 mm between 16 0/7 - 24 0/7 weeks of gestation.)
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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My Duc Hospital
RECRUITINGHo Chi Minh City, Ho Chi Minh City, 70000, Vietnam
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