Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

NCT02708264 | Unknown DMC

• 1 other identifier: 214/2015
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Spontaneous Preterm delivery <34 weeks

  Less than 34 weeks gestation

Secondary Outcomes (8)

• Gestational age

  Time of delivery

• Birth weight

  Time of delivery

• Spontaneous preterm birth rates <37, <28 and <24 weeks

  Less than 24, 28, 34 and 37 weeks gestation

• Spontaneous rupture of membranes

  Less than 34 weeks gestation

• Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)

  Time of delivery

Study Arms (2)

Cervical Pessary

EXPERIMENTAL

The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)

Device: Cervical pessary

No intervention

NO INTERVENTION

No pessary No pessary will be used. Subjects will receive standard obstetrical management

Interventions

Cervical pessary DEVICE

The cervical pessary is a silicone device that has been used to prevent SPTB

Cervical Pessary

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Twin pregnancy (limits the participants to female gender)
• Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation

You may not qualify if:

• Singleton or higher order than twins multiple gestation
• Monoamniotic twins
• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessor and data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 15, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)