Cervical pessary for bleeding reduction in placenta previa
Official title: Prospective, Randomised, Multicentre Study to Investigate the Effect of a Cervical Pessary on the Rate of Bleeding in Patients With Placenta Praevia
Run by Asklepios proresearch · NCT07667777 · Data updated 2026-11-12
This study tests whether placing a cervical pessary can reduce vaginal bleeding and help prolong pregnancy in women with placenta previa or a low-lying placenta.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 190 (estimated) |
| Sponsor | Asklepios proresearch Industry-sponsored |
| Locations | 1 site (Hamburg-Nord) |
| Status | Recruiting |
| Started | June 2026 |
| Main results expected | May 2027 |
| Study ends | July 2027 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07667777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–45 with singleton pregnancy and ultrasound-confirmed placenta previa or a low-lying placenta (<20 mm from the internal os) diagnosed between 20 and 30 weeks, without contraindications.
✕Probably not a fit
Women with contraindications (e.g., active infection, cervical dilation, cervical tears, silicone allergy) or those unlikely to benefit due to underlying conditions may not experience improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective, randomized, multicenter trial, pregnant women with singleton pregnancies and ultrasound-confirmed placenta previa or a low-lying placenta between 20 and 30 weeks will be assigned to receive a cervical pessary or standard care. The study will compare bleeding-related outcomes and the duration of pregnancy between the two groups to determine safety and potential benefits. Eligible participants are 18 to 45 years old, and key exclusion criteria include multiple gestations, fetal abnormalities, active infection, and prior pessary use. The intervention uses a silicone Arabin pessary placed around the cervix, aiming to reduce mechanical stress and bleeding. The trial seeks to provide randomized prospective evidence on the effectiveness of pessary treatment in this high-risk population.
Why it matters
Potential benefit: If successful, the pessary could reduce bleeding and extend gestation, potentially improving maternal and fetal outcomes.
How similar studies have gone: Previous smaller studies suggested potential benefit but evidence was limited and inconclusive; this trial adds randomized prospective data.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Asklepios Klinik Barmbek
Hamburg-Nord, Germany Recruiting
Study contacts
- Principal investigator: Ioannis Kyvernitakis, Prof. Dr. — Asklepios Klinik Barmbek
- Study coordinator: Ioannis Kyvernitakis, Prof. Dr.
- Email: i.kyvernitakis@asklepios.com
- Phone: +49 40 18 18-828370
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.