Prophylactic Cervical Cerclage in Twin Pregnancies With Non-shortened Cervix

The Value of Prophylactic Cervical Cerclage Against Preterm Birth in Twin Pregnancies With History of Preterm Birth and Non-shortened Cervix: A Randomized Controlled Trial

This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Twin Pregnancy, Antepartum Condition or Complication; Cervical Cerclage
• Intervention / Treatment: Procedure: Cervical cerclage

Detailed Description

Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant deaths.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births5, Fuchs and Senat6 concluded that cervical cerclage in asymptomatic twins did not reduce the risk of PTB. This conclusion came depending on small sample sized randomized trail done on less than 50 patients.7 Available meta-analytic data remained of limited value in view of the few and small clinical studies that were included.

Although the current meta-analyses indicate the lack of efficacy of cerclage in twin pregnancies, data from the US Standard Certificate of Live Birth indicated that roughly 10% of triplets and 1.3% of twins are still receiving cerclage.8 Some authors compared the efficacy of cerclage in twin pregnancies and singleton pregnancies and showed that women with twin pregnancies who received cerclage might show beneficial obstetric outcomes similar to those of women with singleton gestations.9,10 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hytham Atia; Phone Number: +966538308500; Email: hythamatia@gmail.com

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44519
      • Recruiting
      • Faculty of Medicine, Zagazig University
      • Contact: Hytham Atia, M.D.; Email: hythamatia@gmail.com
      • Principal Investigator: Amro El Nemr, M.D.
      • Principal Investigator: Mohamed Lashin, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18-50 years.
• Dichorionic twins.
• History of ≥1 preterm birth.
• Transvaginal sonographic cervical length is ≥25 mm at 14-20 weeks gestational age.
• Asymptomatic.

Exclusion Criteria:

• Triplets and quadruplets.
• Monochorionic twins.
• Threatened/ inevitable miscarriage
• Bulging membranes through the external os.
• Extremes of age.
• Major fetal anomalies.
• Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis… etc.
• Fetal demise.
• Fetal reduction in the current pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; cervical cerclage between 14 and 20 weeks will be done by one of the three authors. McDonald cervical cerclage.	Procedure: Cervical cerclage; McDonald cervical cerclage will be applied using Mersaline braided tape with double needle. Single stitch (4 bites) will be applied as close as possible to the level of internal os. The Knot will be put either anterior or posterior according to the surgeon desire.
No Intervention: Group B; Routine antenatal care without cerclage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of preterm birth at ≤35+6, ≤33+6, and ≤31+6 weeks.	Number of preterm deliveries stratified according to gestational age groups mentioned	immediately after delivery for study cases through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of miscarriage.	Number of missed, inevitable and complete miscarriage less than 20 weeks	immediately after occurrence of miscarriage through study completion, an average of 1 year
Incidence of cervico-vaginal infection	Number of infections diagnosed by patient complaint, clinical examination and confirmed by culture and sensitivity	once reported or confirmed during pregnancy through study completion, an average of 1 year
Incidences of bad Neonatal outcomes in both groups	Number of of neonates with respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission	during early neonatal follow up through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Amro El Nemr, Zagazig University; Principal Investigator: Mohamed Lashin, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Estimated): September 28, 2023
• Study Completion (Estimated): October 15, 2023

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: April 16, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: ZU-IRB #8084/17-10-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No