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?

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Insufficiency
• Intervention / Treatment: Procedure: Type of cerclage procedure Mc Donald

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.

• Study Type: Observational
• Enrollment (Anticipated): 22

Contacts and Locations

• Study Contact: Name: Neval Çayönü Kahraman, MD; Phone Number: +905336212174; Email: nevalcayonu@gmail.com
• Study Contact Backup: Name: Mehmet Obut, MD; Phone Number: +905056710339; Email: drmehmetobut@hotmail.com

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06010
      • Recruiting
      • Etlik Zubeyde Hanım Women's Health Training and Research hospital
      • Contact: Neval Çayönü Kahraman, MD; Phone Number: +905336212174; Email: nevalcayonu@gmail.com
      • Contact: Mehmet Obut, MD; Phone Number: +905056710339; Email: drmehmetobut@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 18-45 years old, have not any maternal chronic ilnesses, have not amnion fluid abnormalities, underwent cervical cerclage according to ACOC criteria between 16-23 gestational weeks.

Description

Inclusion Criteria:

• Singleton pregnancy between 16-23 weeks of gestation and between the ages of 18-45
• According to ACOG based on history (Having one or more painless abortions between 16-22 weeks of gestation , a history of cerclage
• According to ACOG based on physical examination ( fetal membranes prolapsed from endocervical canal or not, cervical dilation present )
• Accoding to ACOG based on ultrasound examination ( if there is no previous history of preterm birth , if the cervical length is 10mm or less, if the cervical length is less than 25mm with a history of preterm birth )

Exclusion Criteria:

• Multiple pregnancies
• Pregnant women with premature rupture of membranes
• Pregnant women with uterine anomalies
• Pregnant women with fetal anomalies
• Pregnant women with Gestational diabetes mellitus, Chronic or gestational hypertension , fetal growth restriction , oligohydroamnios or polihydroamnios

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical cerclage area	cervical cerclage will be measured in the axial plane of the cervix by transvaginal ultrasonography	Between 16-23 weeks of pregnancy
Preterm birth	The incidence of patients delivered before 37. gestational weeks	From date of cervical cerclage to delivery

Collaborators and Investigators

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• Investigators: Study Director: Can Tekin Iskender, MD, Helath Sciences University, Etlik Zubeyde Hanım Women's Health Training and Research Hospital

Publications and helpful links

General Publications

• Kahraman N, Obut M. Area of cervical cerclage

Helpful Links

• my e-mail

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Anticipated): January 21, 2023
• Study Completion (Anticipated): February 23, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cerclage area; incidence of preterm birth; Mc Donald
• Additional Relevant MeSH Terms: Uterine Cervical Diseases; Uterine Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Abortion, Habitual; Abortion, Spontaneous; Premature Birth; Uterine Cervical Incompetence
• Other Study ID Numbers: 2021/132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No