Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07667777

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

Conditions: Placenta Previa

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 190
Sponsor: Asklepios proresearch

Location: Asklepios Klinik Barmbek Hamburg-Nord

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.

Eligibility Criteria

Inclusion Criteria: * Age 18 to 45 years * Singleton pregnancy * Ultrasound-confirmed placenta previa (total or marginal) diagnosed between 20 and 30 weeks of gestation * Or low-lying placenta with placental edge less than 20 mm from the internal os * Written informed consent provided Exclusion Criteria: * Multiple pregnancy * Fetal malformations or chromosomal abnormalities detected by ultrasound * Uterine malformations * Silicone allergy * Cervical dilation * Cervical or vaginal infection * Cervical cancer * Cervical tears, cervical scarring, or ectopic cervical tissue * Preterm prelabor rupture of membranes * Regular uterine contractions * Cerclage in place * Pessary already in place * Active bleeding * Genital prolapse grade III or IV

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07667777). StuddyBuddy aggregates publicly available trial information.