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

Second Trimester Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164067
• Other study ID #: 2011-KAEK-25 2022/04-52
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: December 2023
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Second Trimester Abortion

Intervention

Other:
• abortus within 24 hours or 24-48 hours
second trimester medical termination

Locations

Country	Name	City	State
Turkey	Nefise Nazli YENIGUL	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of predictivity cervical consistency index, anterior uterocervical angle and posterior uterocervical angle	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	compare the measured ultrasonographic values	compare the measured ultrasonographic values with the success of predictivity cervical length.( millimeter)	6 months