Placenta Previa Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Asklepios Klinik Barmbek
RECRUITING
Hamburg-nord
Contact Information
Primary
Ioannis Kyvernitakis, Prof. Dr.
i.kyvernitakis@asklepios.com
+49 40 18 18-828370
Backup
Antonia Schenzler
antonia.schenzler@outlook.com
+49 151 20 11 49 06
Time Frame
Start Date: 2026-06
Estimated Completion Date: 2027-07
Participants
Target number of participants: 190
Treatments
Experimental: Cervical pessary plus standard care
Participants receive placement of an Arabin cervical pessary between 20 and 30 weeks of gestation in addition to standard care. Pessary position is monitored by 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.
No_intervention: Standard care
Participants receive standard guideline-based management without placement of a cervical pessary. Clinical assessment and ultrasound follow-up are performed at the same regular 4-week intervals as in the intervention group until delivery.
Related Therapeutic Areas
Sponsors
Leads: Asklepios proresearch

This content was sourced from clinicaltrials.gov