Prevention of Preterm Birth With a Pessary in Triplet

Phase 2

Withdrawn

• Conditions: Preterm Birth
• Interventions: Device: Cervical Pessary

• Registration Number: NCT02601443
• Lead Sponsor: Federico II University

Brief Summary

The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality.

A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL \<25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls.

The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations.

We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL \<30 mm)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 18-50 years of age
• Triplet pregnancy (limits the participants to female gender)
• Gestational age at randomization between 20(0) and 22(6)

Exclusion Criteria

• Singleton, twin or higher order than triplets multiple gestation
• Twin twin transfusion syndrome
• Ruptured membranes
• Lethal fetal structural anomaly
• Fetal chromosomal abnormality
• Cerclage in place (or planned placement)
• Vaginal bleeding
• Suspicion of chorioamnionitis
• Ballooning of membranes outside the cervix into the vagina
• Painful regular uterine contractions
• Labor
• Placenta previa

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Pessary	Cervical Pessary	Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.

Primary Outcome Measures

Name	Time	Method
Preterm delivery	Less than 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Birth weight	Time of delivery
Neonatal death	Between birth and 28 days of age
Chorioamnionitis	Time of delivery
pontaneous preterm birth rates	Less than 24, 28, 34 and 37 weeks gestation
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery	Time of delivery
Significant adverse maternal effects	Time of delivery	Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture
Preterm delivery	Less than 24, 28 and 37 weeks
Admission to neonatal intensive care unit	Between birth and 28 days of age
Gestational age at delivery	Time of delivery
Spontaneous rupture of membranes	Less than 34 weeks gestation
Composite adverse neonatal outcome	Between birth and 28 days of age	Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Intolerance to pessary	Prior to delivery	Defined as request for removal secondary to discomfort and/or discharge

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Naples, Italy