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Cervix checks after preterm labor scare may predict early delivery

NCT ID NCT05044143

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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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 303 pregnant women who had a threatened preterm labor episode but did not deliver right away. Researchers measured their cervix length with ultrasound at several time points to see if shortening over time could predict spontaneous preterm birth before 37 weeks. The goal is to improve prediction and possibly guide future care.

What this could mean

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

What this could lead to
If successful, this could lead to a better way to predict which women are at risk of delivering early after a preterm labor scare.
What could go wrong
This is an observational study, not a treatment trial. It may not find a clear link, and results 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.

Participants

303 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2024

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.

Who is studied

Women who remained undelivered after their first episode of threatened preterm labor, whose cervical length upon hospital discharge is \< 25 mm

Ages

18 to 45 years

Sex

Female participants only

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: * Singleton pregnancy at 23+0 - 33+6 weeks' gestation * Age \> 18 years old * Patients should be capable of providing consent to participate in the study Exclusion Criteria: * Previous spontaneous preterm (20+0 - 36+6 weeks' gestation) delivery (including history of pregnancy loss due to cervical incompetence, i.e painless cervical dilatation prior to 24 weeks' gestation) * Treatment with 17 hydroxyprogesterone caproate due to a previous spontaneous preterm delivery * Detection of a cervical length \< 25 mm during routine ultrasound \< 24 weeks' gestation in asymptomatic patients (i.e patients that do not complain of uterine contractions or patients with no uterine contractions documented on tocometry) * Treatment with vaginal progesterone or micronized progesterone due to a cervical length \< 25 mm * Cerclace placement in the current or in a previous pregnancy * Multiple pregnancy * Age \< 18 years old * Preterm premature rupture of membranes (pPROM) upon initial presentation * Müllerian malformations * Prior cervical surgery

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Department of Obstetrics and Gynecology, Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery

    Monza, Italy

  • Divisione di Ginecolgia ed stetricia, Azienda Ospedaliera Vimercate-Desio presidio di Carate Brianza Giussano, e Università di Milano Bicocca

    Milan, Italy

  • Divisione di Ginecologia ed Ostetricia, Dipartimento Materno infantile, Arcispedale Santa Maria Nuova, IRCCS

    Reggio Emilia, Italy

  • Facoltà di Medicina e Chirurgia, università politecnica delle Marche

    Ancona, Italy

  • Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Clinica Mangiagalli, Università di Milano

    Milan, Italy

  • Mariarosaria Di Tommaso, Divisione di Ginecologia ed Ostetricia, Dipartimento Assistenziale Integrato Materno Infantile, Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy

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