Progesterone or pessary: which prevents preterm birth better?
NCT ID NCT02511574
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether natural progesterone or a cervical pessary (a silicone ring placed in the vagina) is better at preventing early birth in pregnant women with a short cervix (25 mm or less). The trial included 203 women with a single baby. Researchers tracked how many gave birth before 34 weeks. The goal is to find the most effective way to reduce preterm births and improve newborn health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- natural progesterone (drug) and cervical pessary (device)
- What this could lead to
- If one option proves clearly better, it could become the standard way to prevent preterm birth in women with a short cervix, reducing health risks for babies.
- What could go wrong
- This is a single completed study with 203 participants, so results may not apply to all pregnant women. Neither treatment is a guarantee, and some women may still deliver early.
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
-
203 people
The number who actually took part.
- Started
-
Aug 2015
- Finished
-
Aug 2023
- 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
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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 Hide 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: * gestational age between 20 weeks and 23 weeks and 6 days * singleton pregnancies Exclusion Criteria: * fetal death at randomization * major structural or chromosomal abnormality * cervical cerclage in the current pregnancy * preterm rupture of membranes diagnosed before randomization
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Premature birth are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an asthma inhaler drug open narrowed airways in preterm kids?
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Why do some preterm babies need breathing machines longer?
- Can a Preemie's NICU breathing pattern predict asthma and sleep problems years later?
- Why do some preterm babies fail to grow? researchers track clues in the NICU
- Scientists test whether calmer mothers make better milk