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Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia

NCT07667777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-07-27

No results posted yet for this study

Summary

This study evaluates whether use of a cervical pessary can reduce vaginal bleeding and prolong pregnancy in women with placenta previa or a low-lying placenta. Placenta previa is a condition in which the placenta covers or lies close to the cervix and may cause serious bleeding, preterm birth, and complications for both the pregnant woman and the baby.

In this prospective, randomized, multicenter study, eligible women with singleton pregnancies and ultrasound-confirmed placenta previa or low-lying placenta between 20 and 30 weeks of gestation will be assigned either to treatment with an Arabin cervical pessary or to standard care without a pessary. The study will compare bleeding-related outcomes and pregnancy duration between the two groups.

The study is designed to determine whether a cervical pessary is a safe and effective intervention for reducing bleeding-related complications and prolonging gestation in this high-risk pregnancy population.

Conditions

  • Placenta Previa

Interventions

DEVICE

Cervical pessary

Placement of a cervical pessary (Arabin pessary) by an experienced gynecologist between 20 and 30 weeks of gestation in pregnant women with placenta previa or a low-lying placenta. Pessary position is monitored by ultrasound, preferably transvaginal ultrasound, at regular 4-week intervals until delivery. The pessary is removed at the onset of labor, before planned cesarean delivery, or earlier if clinically indicated because of complications such as infection or intolerance.

Sponsors & Collaborators

  • Asklepios proresearch

    lead INDUSTRY

Principal Investigators

  • Ioannis Kyvernitakis, Prof. Dr. · Asklepios Klinik Barmbek

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-05-31
Completion
2027-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07667777 on ClinicalTrials.gov