Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Stitch and hormone combo may stop preterm birth

NCT ID NCT06463652

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 328 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Preterm birth are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Premature Birth

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • My Duc Hospital

    RECRUITING

    Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.