Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix

NCT05338164 | Completed DMC

• 1 other identifier: ZU-IRB #8090/17-10-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.

Conditions

Preterm Birth; Twin Pregnancy With Antenatal Problem; Cervical Shortening

Outcome Measures

Primary Outcomes (1)

• The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm

  Rate of preterm births stratified by gestational age inside the included women

  Immediate reporting of cases at time of delivery through study completion, an average of 1 year

Secondary Outcomes (4)

• Subgroup analysis for the risk of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤15 mm

  Immediate reporting of cases at time of delivery through study completion, an average of 1 year

• The incidence of miscarriage.

  Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year

• Incidence of cervico-vaginal infection

  after confirmation of infection through study completion, an average of 1 year

• Neonatal outcomes in both groups

  early neonatal through study completion, an average of 1 year

Study Arms (2)

Cerclage group

EXPERIMENTAL

cervical cerclage between 14 and 20 weeks will be done by one of the three authors.

Procedure: cervical cerclage

No Cerclage group

NO INTERVENTION

Routine follow up without cerclage

Interventions

cervical cerclage PROCEDURE

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.

Cerclage group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant ladies
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-45 years.
• Dichorionic twins.
• Transvaginal sonographic cervical length is \<25 mm with or without internal os dilatation ≥10 mm at 14-20 weeks gestational age.
• Asymptomatic.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

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 Officials

• Mohamed Lashiin, M.D.

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Amro El Nemr, M.D.

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: April 21, 2022
• Study Start: December 20, 2021
• Primary Completion: August 27, 2024
• Study Completion: October 31, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)