Clinical trial NCT02601443: Prevention of Preterm Birth With a Pessary in Triplet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)


Eligibility criteria: 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

Primary outcomes:
measure: Preterm delivery
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: Time of delivery
measure: Birth weight
timeFrame: Time of delivery
measure: pontaneous preterm birth rates
timeFrame: Less than 24, 28, 34 and 37 weeks gestation
measure: Spontaneous rupture of membranes
timeFrame: Less than 34 weeks gestation
measure: Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
timeFrame: Time of delivery
measure: Neonatal death
timeFrame: Between birth and 28 days of age
measure: Composite adverse neonatal outcome
timeFrame: Between birth and 28 days of age
measure: Admission to neonatal intensive care unit
timeFrame: Between birth and 28 days of age
measure: Chorioamnionitis
timeFrame: Time of delivery
measure: Significant adverse maternal effects
timeFrame: Time of delivery
measure: Intolerance to pessary
timeFrame: Prior to delivery
measure: Preterm delivery
timeFrame: Less than 24, 28 and 37 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Gabriele Saccone
Study officials:
References: