Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

NCT00706264

Preterm Birth

COMPLETED NA

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

NCT01242410

Preterm Birth

COMPLETED PHASE4

Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix

NCT02849301

Preterm Birth

WITHDRAWN PHASE3

Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB

NCT03418012

Preterm Birth Premature Birth

UNKNOWN NA

Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor

NCT03543475

Preterm Birth

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Expectant Management

Group Type NO_INTERVENTION

No interventions assigned to this group

Placement of cervical pessary since 23 weeks until 37 weeks

Group Type EXPERIMENTAL

Device: Silicon ring (Arabin Pessary)

Intervention Type DEVICE

Placement of a silicon pessary in the vagina, around the cervix.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Device: Silicon ring (Arabin Pessary)

Placement of a silicon pessary in the vagina, around the cervix.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Minimal age of 18 years
* Episode of threatened preterm labour

Exclusion Criteria

* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Active vaginal bleeding
* Placenta previa

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No