Relation of the Area of Cerclage With Preterm Birth

NCT05220839 | Unknown DMC

• 1 other identifier: 2021/132
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Insufficiency

Keywords

cerclage area; incidence of preterm birth; Mc Donald

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Type of cerclage procedure Mc Donald PROCEDURE

Patients who underwent Mc Donald cervical cerclage will be calculated the area of cervical cerclage area

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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 )

You may not qualify if:

• 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

Sponsors & Collaborators

• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital: lead

Study Sites (1)

Etlik Zubeyde Hanım Women's Health Training and Research hospital

Ankara, Keçiören, 06010, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Kahraman N, Obut M. Area of cervical cerclage

  BACKGROUND

Related Links

• my e-mail

MeSH Terms

Conditions

Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases

Study Officials

• Can Tekin Iskender, MD

  Helath Sciences University, Etlik Zubeyde Hanım Women's Health Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Neval Çayönü Kahraman, MD

CONTACT

+905336212174; nevalcayonu@gmail.com

Mehmet Obut, MD

CONTACT

+905056710339; drmehmetobut@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow in perinatology

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 21, 2022
• Primary Completion: January 21, 2023
• Study Completion: February 23, 2023
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)