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New study tests if a simple device can shorten a difficult procedure

NCT ID NCT03194230

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at whether placing a cervical dilator (a small rod that expands) before medication can shorten labor during a second-trimester termination of pregnancy. Researchers compared 355 women who either got the dilator plus standard medication or medication alone. The main goal was to see if more women delivered within 12 hours with the dilator.

What this could mean

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

Active substance
hygroscopic cervical dilator (Dilapan-S)
What this could lead to
If effective, using cervical dilators could make second-trimester termination of pregnancy faster and more comfortable for patients.
What could go wrong
This is a completed study, but the results are not yet widely confirmed. The approach may not work for everyone and carries risks like infection or failed induction.

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

355 people

The number who actually took part.

Started

Dec 2017

Finished

Nov 2020

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: * Termination of pregnancy requested by the patient and accepted by the weekly multidisciplinary counselling of fetal medicine * gestational age between 15 and 27 weeks and 6 days, * single pregnancy, * major patient, * French-speaking woman, * Patient with health insurance. Exclusion Criteria: * Termination of pregnancy by surgical technique * cicatricial uterus * premature rupture of membranes * chorioamnionitis * multiple pregnancy * placenta praevia * myoma praevia * uterine malformation * unstable maternal pathology * psychiatric pathology * contraindication to mifepristone: severe asthma, adrenal insufficiency, porphyria, corticotherapy. * contraindication to misoprostol: hypersensitivity to prostaglandins. * contraindication to epidural analgesia: hemostasis disorder, spinal or medullary anomaly. * Bishop score \> or = to 7 at arrival in birth room

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Termination of pregnancy (TOP)

Contacts and locations

Locations

  • Maternité Port Royal

    Paris, 75014, France