Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length

NCT02746900 | Unknown Phase 4 DMC

• 1 other identifier: 100/16
• Study Type: interventional
• Target: 587
• 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. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. Different strategies have been adopted for prevention of SPTB. Growing interest has focused on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use, does not require anesthesia, can be used in an outpatient clinic setting, and it is easily removed when necessary. However, a recent systematic review and meta-analysis of randomized clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7 However, even if the statistical significance were not reached, they found a reduction in SPTB \<35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%; relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15). Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without prior SPTB.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Spontaneous preterm birth (SPTB)

  Less than 35 weeks gestation

Secondary Outcomes (10)

• Spontaneous preterm birth (SPTB)

  Less than 37,34,32,28 and 24 weeks gestation

• Gestational age at delivery

  Delivery (at birth)

• Latency

  Delivery (at birth)

• chorioamnionitis

  Delivery (at birth)

• Birth weight

  Delivery (at birth)

Study Arms (2)

Cervical cerclage

EXPERIMENTAL

After the woman is placed in the dorsal lithotomy position and the bladder is emptied with a urinary catheter to reduce the chance of bladder injury, surgical preparation with Betadine will be performed. Breisky retractors and Sims retractors will be used to exposure the entire cervix. Sponge ring forceps will be used to optimized visualization of the cervix and provide the necessary countertraction at the suture entry and exit sites. McDonald technique will be performed placing 4-6 bites circumferentially around the cervix. Only one stitch will be used. The suture will be places as high as feasible

Procedure: Cervical cerclage

No intervention

NO INTERVENTION

Bed rest will be not recommended.

Interventions

Cervical cerclage PROCEDURE

McDonald cervical cerclage

Cervical cerclage

Eligibility Criteria

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

You may qualify if:

• ages
• Singleton pregnancy
• Cervical length \<=25mm between 18(0) and 23(6) weeks

You may not qualify if:

• Multiple pregnancy
• Prior spontaneous preterm birth or second trimester losses between 16(0) and 36(6) weeks
• Cerclage in situ
• Painful regular uterine contraction and/or preterm labor
• Ruptured membranes
• Major fetal defects
• Active vaginal bleeding
• Placenda previa and/or accreta
• Cervical dilation \>1.5 cm and/or visible membranes by pelvic exam
• Suspicion of chorioamnionitis

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 4
• 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: April 8, 2016
• First Posted: April 21, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

IT (1)