Relation of the Area of Cerclage With Preterm Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-21

Study Completion Date

2023-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

NCT02479932

Labor Pain

COMPLETED NA

The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section

NCT05948436

Postpartum Hemorrhage Cesarean Section Complications

COMPLETED NA

Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial

NCT01954719

Failure of Cervical Dilatation Complications; Cesarean Section Wound Infection, +1 more

UNKNOWN NA

A Two-Layered Simple Interrupted Myometrial Suturing Reduces Uterine Niche Formation After Primary Cesarean Section

NCT07229222

Cesarean Section Complications Scar Niche Myometrial Remodeling +1 more

ACTIVE_NOT_RECRUITING NA

Femoral Vein Collapsibility Index and Post-Spinal Hypotension in Pregnant Women: Impact of Position

NCT06885593

Spinal Induced Hypotension in Cesarean Delivery

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Type of cerclage procedure Mc Donald

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes