Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

NCT02716922 | Unknown Phase 3

• 1 other identifier: 33/2016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Spontaneous preterm birth rates <34weeks

  Less than 34 weeks gestation

Secondary Outcomes (13)

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

  Less than 24, 28, and 37 weeks gestation

• Type of delivery

  Time of delivery

• Spontaneous rupture of membranes

  Less than 34 weeks gestation

• Neonatal death

  Between birth and 28 days of age

• birth weight

  Time of delivery

Study Arms (2)

Cervical cerclage

EXPERIMENTAL

Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix

Procedure: Cervical cerclage

No intervention

NO INTERVENTION

No cerclage Women randomized to not receive cerclage represent the control arm

Interventions

Cervical cerclage PROCEDURE

Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)

Cervical cerclage

Eligibility Criteria

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

You may qualify if:

• Singleton pregnancy (limits the participants to female gender)
• Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
• years of age

You may not qualify if:

• Multiple gestation
• Prior spontaneous preterm birth 16-36 6/7 weeks
• Ruptured membranes
• Lethal fetal structural anomaly
• Fetal chromosomal abnormality
• Pessary in place (or planned placement)
• Vaginal bleeding
• Suspicion of chorioamnionitis
• Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
• Painful regular uterine contractions
• Placenta previa

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• 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 23, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)