Second Trimester AbortionNCT06164067
The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination
An observational study of Second Trimester Abortion and Uterocervical Angle, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Trimester Abortion, Uterocervical Angle, Cervical Consistency Index
- What is being tested?
- abortus within 24 hours or 24-48 hours
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Aug 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: white people same demographics no socio- cultural difference
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- abortus within 24 hours or 24-48 hours
- Keywords
- medical termination, uterocervical angle, abortion, second trimester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abortus within 24 hours or 24-48 hoursOther
Also called misoprostol
second trimester medical termination
| Study group | Role | What they receive |
|---|---|---|
| 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 ) Receives: 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. Receives: Other: abortus within 24 hours or 24-48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
compare the measured ultrasonographic values
compare the measured ultrasonographic values with the success of predictivity cervical length.( millimeter)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start15 Feb 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Trimester AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164067
- Sponsor's protocol ID
- 2011-KAEK-25 2022/04-52
- Status last verified
- Dec 2023
- First submitted
- 4 Apr 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cervical Consistency Index and Uterocervical Angles in Predicting Second Trimester Medical Termination
- ClinicalTrials.gov ID
- NCT06164067
- Acronym / sponsor ID
- 2011-KAEK-25 2022/04-52
- Keywords
- medical termination, uterocervical angle, abortion, second trimester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women who abort within 24 hours | – | Other: abortus within 24 hours or 24-48 hoursGroup 1 treatment was completed in the first 24 hours ( who were completely aborted and removed the fetal material and its attachments ) |
| Pregnant women who abort within 24- 48 hours | – | Other: abortus within 24 hours or 24-48 hoursGroup 2 consisted of patients who needed additional cycles and aborted within 24-48 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- white people same demographics no socio- cultural difference
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abortus within 24 hours or 24-48 hoursAlso: misoprostolsecond trimester medical termination | Other | Pregnant women who abort within 24 hours, Pregnant women who abort within 24- 48 hours |
Primary outcome
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)
1 secondary outcome
compare the measured ultrasonographic values
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Second Trimester Abortion and Uterocervical Angle, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of predictivity cervical consistency index, anterior uterocervical angle and posterior uterocervical angle (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.