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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAsklepios proresearch

About this trial

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

Qualifiers

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

Disqualifiers

Multiple pregnancy

Fetal malformations or chromosomal abnormalities detected by ultrasound

Uterine malformations

Silicone allergy

Trial design

Treatments tested in this trial

  • Cervical pessary

Treatment groups

190 Participants
are divided into 2 treatment groups

Sponsors and collaborators