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

NCT07667777 | Recruiting

• 1 other identifier: 2025-101622-BO-ff
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (3)

• Number of Vaginal Bleeding Episodes From Randomization to 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.

  From randomization until delivery

• Number of Participants Undergoing Cesarean Delivery Due to Bleeding

  Number of participants who undergo cesarean delivery because of vaginal bleeding after randomization.

  From randomization until delivery

• Gestational Age at Cesarean Delivery

  Gestational age at the time of cesarean delivery.

  At cesarean delivery

Secondary Outcomes (14)

• Number of Hospital Admissions Due to Bleeding From Randomization to Delivery

  From randomization until delivery

• Total Number of Hospital Days From Randomization to Delivery

  From randomization until delivery

• Time to First Vaginal Bleeding Episode After Randomization

  From randomization until delivery

• Number of Bleeding-Free Days From Randomization to Delivery

  From randomization until delivery

• Change in Maternal Hemoglobin From Start of Pregnancy to Delivery.

  From start of pregnancy to delivery

Study Arms (2)

Cervical pessary plus standard care

EXPERIMENTAL

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.

Device: Cervical pessary

Standard care

NO INTERVENTION

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.

Interventions

Cervical pessary DEVICE

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.

Cervical pessary plus standard care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asklepios proresearch: lead

Study Sites (1)

Asklepios Klinik Barmbek

Hamburg-Nord, 22307, Germany

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Ioannis Kyvernitakis, Prof. Dr.

  Asklepios Klinik Barmbek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioannis Kyvernitakis, Prof. Dr.

CONTACT

+49 40 18 18-828370; i.kyvernitakis@asklepios.com

Antonia Schenzler

CONTACT

+49 151 20 11 49 06; antonia.schenzler@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Section, Specialist in Gynecology and Obstetrics, specializing in Special Obstetrics and Perinatal Medicine

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups: cervical pessary plus standard care or standard care alone. Randomization will be performed centrally using a web-based platform with stratified block randomization, with stratification by study center and maternal age. Participants in the intervention group will receive placement of an Arabin pessary between 20 and 30 weeks of gestation and will undergo regular ultrasound monitoring every 4 weeks until delivery. Participants in the control group will receive standard guideline-based management without pessary placement and the same schedule of clinical and ultrasound follow-up. Outcomes will be compared between groups from randomization until delivery and through the 6-week postpartum follow-up period.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

DE (1)