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NOT YET RECRUITING
NCT07667777
NA

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

Sponsor: Asklepios proresearch

View on ClinicalTrials.gov

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.

Official title: Prospective, Randomised, Multicentre Study to Investigate the Effect of a Cervical Pessary on the Rate of Bleeding in Patients With Placenta Praevia

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2026-06

Completion Date

2027-07

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

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.

Locations (1)

Asklepios Klinik Barmbek

Hamburg-Nord, Germany