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Vaginal gel or shot: which better prevents preterm birth?

NCT ID NCT02913495

Prevention Sponsor: Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two forms of progesterone—vaginal gel and a shot—to see which works better at preventing another preterm birth in women who had one before. About 210 pregnant women with a prior preterm birth took part. The goal was to find out if the vaginal option is more effective than the standard shot.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
progesterone (vaginal or intramuscular)
What this could lead to
If successful, this could show that vaginal progesterone is better at preventing recurrent preterm birth than the standard shot, offering a simpler option.
What could go wrong
This trial is completed but results are not yet widely confirmed. It only included women with a prior preterm birth, so findings may not apply to all pregnant women.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

210 people

The number who actually took part.

Started

Sep 2016

Finished

Sep 2021

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

Accepted

You do not need to have the condition being studied to take part.

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: * Pregnant women with singleton pregnancies * ≥18 years old * Estimated gestational age less than 24 0/7 weeks * Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks. * Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. Exclusion Criteria: * History of an adverse reaction to progesterone; * A contraindication to progesterone treatment; * Placenta previa or accreta; * Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder; * Multifetal gestation; * Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment

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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.

Premature birth

Contacts and locations

Locations

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • George Washington University

    Washington D.C., District of Columbia, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

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