Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix

Preterm Birth Clinical Trial

Official title:

Protective Value of Cervical Cerclage Against Preterm Birth in Twin Pregnancy With Short Cervix. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338164
• Other study ID #: ZU-IRB #8090/17-10-2021
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: July 2023
• Source: Zagazig University
• Contact: Hytham Atia, M.D
• Phone: +966538308500
• Email: hythamatia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 15, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Shortening
• Premature Birth
• Preterm Birth
• Twin Pregnancy With Antenatal Problem

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subgroup analysis for the risk of preterm birth at =33+6, and =31+6 weeks with cervical length =15 mm	subgroup analysis for rate of preterm births for very short cervix	Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Secondary	The incidence of miscarriage.	rate of missed, inevitable and complete miscarriages	Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year
Secondary	Incidence of cervico-vaginal infection	Rate of infections diagnosed during pregnancy by patient complaint, clinical examination and confirmed by culture and sensitivity).	after confirmation of infection through study completion, an average of 1 year
Secondary	Neonatal outcomes in both groups	Rate of untoward early neonatal outcomes respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission	early neonatal through study completion, an average of 1 year