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Could a simple silicone ring prevent dangerous bleeding in pregnancy?

NCT ID NCT07667777

Disease control Sponsor: Asklepios proresearch Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests whether a silicone cervical pessary can reduce vaginal bleeding and help women with placenta previa carry their pregnancy longer. About 190 pregnant women with this condition will either receive the pessary or standard care. The goal is to see if this simple device can improve safety for both mother and baby.

What this could mean

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

Active substance
Cervical pessary (Arabin pessary) - a silicone device placed in the vagina to support the cervix
What this could lead to
If it works, this could give doctors a simple, non-surgical tool to reduce dangerous bleeding and help women with placenta previa carry their pregnancy longer.
What could go wrong
This is an early-stage study with only 190 participants, so results may not apply to everyone. The pessary could cause discomfort, infection, or fail to reduce bleeding.

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 190 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 45 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: * Age 18 to 45 years * Singleton pregnancy * Ultrasound-confirmed placenta previa (total or marginal) diagnosed between 20 and 30 weeks of gestation * Or low-lying placenta with placental edge less than 20 mm from the internal os * Written informed consent provided Exclusion Criteria: * Multiple pregnancy * Fetal malformations or chromosomal abnormalities detected by ultrasound * Uterine malformations * Silicone allergy * Cervical dilation * Cervical or vaginal infection * Cervical cancer * Cervical tears, cervical scarring, or ectopic cervical tissue * Preterm prelabor rupture of membranes * Regular uterine contractions * Cerclage in place * Pessary already in place * Active bleeding * Genital prolapse grade III or IV

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Conditions

The condition(s) this trial relates to.

low implantation of placenta placenta praevia

As listed by the trial registrant

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

Placenta previa

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

  • Asklepios Klinik Barmbek

    RECRUITING

    Hamburg-Nord, 22307, Germany

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