Faculty of medicine, Zagazig University
Zagazig, Sharqia Province, 44519, Egypt
NCT Number: NCT05338164
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Zagazig, Sharqia Province, 44519, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Rate of preterm births stratified by gestational age inside the included women
Time frame: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
subgroup analysis for rate of preterm births for very short cervix
Time frame: Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year
rate of missed, inevitable and complete miscarriages
Time frame: after confirmation of infection through study completion, an average of 1 year
Rate of infections diagnosed during pregnancy by patient complaint, clinical examination and confirmed by culture and sensitivity).
Time frame: early neonatal through study completion, an average of 1 year
Rate of untoward early neonatal outcomes respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission
Zagazig University
Other Gov
Protective Value of Cervical Cerclage Against Preterm Birth in Twin Pregnancy With Short Cervix. A Randomized Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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