NCT06164067

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

April 4, 2023

Last Update Submit

December 1, 2023

Conditions

Keywords

medical terminationuterocervical angleabortionsecond trimester

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • compare the measured ultrasonographic values

    6 months

Study Arms (2)

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

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

Interventions

second trimester medical termination

Also known as: misoprostol
Pregnant women who abort within 24 hoursPregnant women who abort within 24- 48 hours

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

white people same demographics no socio- cultural difference

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 4, 2023

First Posted

December 11, 2023

Study Start

February 15, 2022

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations