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Sponsor: Asklepios proresearch
Conditions: Placenta Previa
Interventions: Cervical pessary
Countries: Germany
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.
Sex: FEMALE
Age: 18 Years to 45 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Hamburg-Nord, Germany