NCT05220839

Relation of the Area of Cerclage With Preterm Birth

Is the Cerclage Area Associated With the Incidence of Preterm Birth in Pregnant Women Undergoing Mc Donald Cerclage?

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Cerclage treatment will be performed with the McDonald technique (the type of cerclage suture will be mersilene) between the 16-23 weeks of gestation in pregnant women with a diagnosis of cervical insufficiency based on the history , physical examination or ultrasound findings according to ACOG. The investigators will measure cerclage area after cerclage treatment (within 0-4 weeks) and different parameters besides it by transvaginal ultrasound. It will be whether the collected data is related to the incidence of preterm birth.

Detailed description

The parameters that will be measured with transvaginal ultrasound are: * Cerclage area in the axial plane of the cervix * Angle between anterior uterine wall and internal os * Angle between anterior uterine wall and external os * Anterior and posterior cervical widht at level of stitch * Anterior and posterior stitch depth (stitch to canal ) * Cervical length above and below cerclage stitch Before the data collection phase ,the required sample number for the research was determined using the G\*power (Faul, Erdfelder, Buchner, \& Lang, 2009) 3.1 program. When the alpha level is .05 and the power is %95 , the total number of samples was found o be 22.

Conditions

• Cervical Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Type of cerclage procedure Mc Donald	Patients who underwent Mc Donald cervical cerclage will be calculated the area of cervical cerclage area

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-01-21
• Completion: 2023-02-23
• First posted: 2022-02-02
• Last updated: 2022-03-04

Locations

1 site across 1 country: Turkey (Türkiye)