The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination

December 1, 2023 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital

The Role of Cervical Consistency Index and Uterocervical Angles in Predicting Second Trimester Medical Termination

The main aim of the investigator study is the success of predictivity cervical consistency index (CCI), anterior uterocervical angle (aUCA) and posterior uterocervical angle (pUCA) in second trimester terminations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective clinical study includes 136 pregnant women with a diagnosis of in utero ex fetus who were hospitalized for medical termination in the gynecology service of Health Sciences University Bursa High Specialization Training and Research Hospital Gynecology and Obstetrics Clinic as a single center. The participants were divided into 2 groups as those whose treatment was completed in the first 24 hours (who were completely aborted and removed the fetal material and its attachments ) and those who aborted within 24-48 hours when additional cycles were needed. Furthermore who applied to additional treatment methods were recorded (cervical balloon, hysterotomy ) during these periods. In all pregnant women; characteristic features, abortion times, doses of misoprostol used, anterior- posterior uterocervical angle, cervical length, cervical consistency indexes and gestational weeks were saved.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16110
        • Nefise nazlı Yenigül

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

white people same demographics no socio- cultural difference

Description

Inclusion Criteria:

  • women who had a termination indication in the second trimester and had abortion or abortion in our hospital
  • women who have had a miscarriage or abortion with a normal vaginal route or hysterotomy

Exclusion Criteria:

  • multiple pregnancies
  • pregnant women with misoprostol-related allergies
  • scar pregnancies or heterotopic pregnancies
  • patients with a history of previous conization or cervical surgery,
  • patients with placental invasion anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women who abort within 24 hours
Group 1 treatment was completed in the first 24 hours ( who were completely aborted and removed the fetal material and its attachments )
Other: abortus within 24 hours or 24-48 hours
second trimester medical termination
Other Names:
  • misoprostol
Pregnant women who abort within 24- 48 hours
Group 2 consisted of patients who needed additional cycles and aborted within 24-48 hours.
Other: abortus within 24 hours or 24-48 hours
second trimester medical termination
Other Names:
  • misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of predictivity cervical consistency index, anterior uterocervical angle and posterior uterocervical angle
Time Frame: 6 months
cervical consistency index (CCI), an ultrasound measurement that aims to estimate cervical softness by measuring the anteroposterior diameter of the uterine cervix before (AP) (millimeter) and at maximal compression (AP') with the vaginal ultrasound probe and calculating the ratio between the two measurements (AP'/AP × 100). Uterocervical angle (UCA) (degree):Transvaginal sonographic images showing technique of measurement of uterocervical angle. UCA was calculated as angle between two lines. The first line was drawn between internal (I) and external ostium (os) (E). The second line was drawn 3 cm parallel to the lower aspect of anterior inner uterine wall passing through the end of the first line at internal os. (in degrees)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the measured ultrasonographic values
Time Frame: 6 months
compare the measured ultrasonographic values with the success of predictivity cervical length.( millimeter)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2022/04-52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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