Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cervical Shortening
Premature Birth
Preterm Birth
Twin Pregnancy With Antenatal Problem

Clinical Trial Details

NCT number	NCT05338164
Study type	Interventional
Source	Zagazig University
Contact	Hytham Atia, M.D
Phone	+966538308500
Email	hythamatia@gmail.com
Status	Recruiting
Phase	N/A
Start date	December 20, 2021
Completion date	November 15, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.