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Twin pregnancy breakthrough? stitch plus hormone may stop preterm birth

NCT ID NCT07319715

Disease control Sponsor: Benha University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a surgical stitch (cervical cerclage) plus a hormone gel (vaginal progesterone) works better than standard care to prevent preterm birth in women carrying twins with a short cervix. 59 women participated, and researchers also checked if the treatment reduced inflammation in cervical fluid. The goal is to help twins reach full term and improve health outcomes.

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
What this could lead to
If successful, this combined approach could offer a new way to reduce preterm births in twin pregnancies, improving outcomes for mothers and babies.
What could go wrong
This is a small Phase 2 trial with only 59 participants, so results may not apply to all twin pregnancies. The procedure and medication carry risks like infection or side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

59 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2025

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 to 50 years

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: * Type of Pregnancy: Women with confirmed twin pregnancy (TP). * Cervical Length: Short cervical length (CL) defined as ≤25 mm. * Timing of Diagnosis: Short cervix detected via transvaginal ultrasound (TVU) at 11-13 weeks + 6 days, or detected during bi-weekly follow-up exams until 23 weeks + 6 days. * Consent: Participants willing to undergo randomization and comply with the follow-up protocol. Exclusion Criteria: * Multiple Gestation (High Order): Triplet or higher-order pregnancies. * Fetal/Uterine Complications: Polyhydramnios, premature rupture of membranes (PPROM), or known uterine abnormalities. * Acute Symptoms: Vaginal bleeding, fever, or signs of fetal distress. * Maternal Comorbidities: Pre-existing or gestational hypertension, and diabetes mellitus.

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As listed by the trial registrant

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

Twin pregnancy with antenatal problem

Contacts and locations

Locations

  • Faculty of Medicine, Benha University

    Banhā, Qalyubia Governorate, 13511, Egypt

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