Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix

NCT ID: NCT05338164

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2024-10-31

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.

Detailed Description

Introduction 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 mortality.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 births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.

Rationale:

Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.

Conditions

Preterm Birth; Twin Pregnancy With Antenatal Problem; Cervical Shortening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cerclage group

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

Group Type: EXPERIMENTAL

cervical cerclage

Intervention Type: 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.

No Cerclage group

Routine follow up without cerclage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hytham Atia

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Lashiin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Amro El Nemr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Faculty of medicine, Zagazig University

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB #8090/17-10-2021

Identifier Type: -

Identifier Source: org_study_id