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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Number of Vaginal Bleeding Episodes From Randomization to Delivery — From randomization until delivery
  Number of vaginal bleeding episodes occurring between randomization and delivery. In the protocol, a bleeding episode is defined as blood loss of at least 50 mL per episode.
• Number of Participants Undergoing Cesarean Delivery Due to Bleeding — From randomization until delivery
  Number of participants who undergo cesarean delivery because of vaginal bleeding after randomization.
• Gestational Age at Cesarean Delivery — At cesarean delivery
  Gestational age at the time of cesarean delivery.

Trial sites (1)

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