Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia
ConditionPlacenta Previa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAsklepios proresearch
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Multiple pregnancy
Fetal malformations or chromosomal abnormalities detected by ultrasound
Uterine malformations
Silicone allergy
Trial design
Design model
Parallel
Treatments tested in this trial
Cervical pessary
DevicePlacement 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.
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: Cervical pessary plus standard careExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From randomization until delivery2
Number of Participants Undergoing Cesarean Delivery Due to Bleeding
Number of participants who undergo cesarean delivery because of vaginal bleeding after randomization.
Time frame
From randomization until delivery3
Gestational Age at Cesarean Delivery
Gestational age at the time of cesarean delivery.
Time frame
At cesarean deliverySecondary outcomes
1
Number of Hospital Admissions Due to Bleeding From Randomization to Delivery
Number of hospital admissions related to vaginal bleeding after randomization.
Time frame
From randomization until delivery2
Total Number of Hospital Days From Randomization to Delivery
Total number of inpatient hospital days from randomization until delivery.
Time frame
From randomization until delivery3
Time to First Vaginal Bleeding Episode After Randomization
Time from randomization to the first vaginal bleeding episode.
Time frame
From randomization until delivery4
Number of Bleeding-Free Days From Randomization to Delivery
Total number of days without vaginal bleeding between randomization and delivery.
Time frame
From randomization until deliverySponsors and contacts
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Source ClinicalTrials.gov