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Can a Two-Week progesterone course buy more time in the womb?

NCT ID NCT06975943

Disease control Sponsor: Dr. Soetomo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether giving pregnant women vaginal progesterone for two weeks after a preterm labor scare can help them carry their baby longer and keep the cervix from shortening. Researchers will enroll 48 women between 28 and 33 weeks of pregnancy who have just recovered from an episode of threatened preterm labor. Half will receive daily 200 mg progesterone capsules, while the other half gets standard care. The study measures how many extra days the pregnancy lasts and how cervical length changes, along with delivery method and 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 micronized progesterone (Microgest) 200 mg daily for two weeks after arrested preterm labor
What this could lead to
If it works, this could offer a simple, low-cost way to help women at risk of preterm birth carry their babies longer, improving outcomes for mothers and newborns.
What could go wrong
This is a small, early-stage trial with only 48 participants, so results may not apply broadly. Progesterone may not prolong pregnancy in all cases, and the study does not yet prove long-term benefits.

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

48 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

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: 1. Singleton pregnant women who have passed the acute phase of Threatened Preterm Labor that meets the following criteria: 1. Persistent contractions (2-3 contractions in 10 minutes) accompanied by cervical dilation assessed based on pelvic examination (Vaginal Touche) 2. Intact amniotic membrane 3. Cervical dilation ≤ 2 cm 4. No birth occurs within 2x24 hours since persistent contractions appear. 2. Age 18-40 years 3. The gestational age must be between 28 weeks and 33 weeks plus 6 days. 4. Able to participate, communicate well with researchers, and willing to provide written consent to participate in the study. Exclusion Criteria: 1. Patients with cervical cerclage in this pregnancy 2. Cervical length is less than 10 mm 3. Congenital abnormalities in the fetus 4. Anatomical abnormalities in the uterus 5. History of antepartum hemorrhage in this pregnancy 6. Known hypersensitivity to progesterone or contraindications to its use. 7. Suspected or proven premature rupture of membranes at enrollment 8. Subjects on drug therapy known to interact with progesterone (eg Bromocriptine, Rifampin, Ketoconazole, and Cyclosporine) 9. Subjects with comorbidities: cardiovascular disease, renal function, liver function, hematological disorders, and other uncontrolled comorbidities. 10. Subjects with stress conditions based on the DASS-42 questionnaire.

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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.

Pregnancies at increased risk of preterm birth Pregnant women

Contacts and locations

Locations

  • Dr. Soetomo General Hospital Surabaya

    Surabaya, East Java, 60286, Indonesia

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