Prevention of Preterm Birth With a Pessary in Triplet

Preterm Birth Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02601443
• Other study ID #: 213/15
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Cervical Pessary

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

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