Medical; Abortion, FetusNCT03400358
Uterocervical Angle in the Pregnancy Termination of Multiparous Women
An observational study of Medical; Abortion, Fetus and Second Trimester Abortion, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical; Abortion, Fetus, Second Trimester Abortion
- What is being tested?
- uterocervical angle
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 1 Feb 2018
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Multiparous pregnant women undergoing medical abortion in the second trimester
Who may be able to join
- multiparous singleton pregnancy
- no previous systemic illnesses
Who cannot join
- abnormal Pap smear
- history of dilatation and curettage (D\&C)
- history of LEEP and cervical conization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterocervical Angle in the Termination of Second Trimester Pregnancy in Multiparous Women
To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women.
Read the detailed description
Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.
The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on multiparous women who are taking Foley baloon for the cervical preparation and aim to measure their UCA.
- Being tested
- uterocervical angle
- Keywords
- uterocervical angle, multiparous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterocervical angleOther
the angle between cervical canal and anterior uterine wall is measured sonographically.
| Study group | Role | What they receive |
|---|---|---|
| Medical abortion | 150 singleton multiparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were multiparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor. Receives: Other: uterocervical angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterocervical angle
the angle between the cervical canal and anterior uterine wall
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Oct 2017
- Primary completion31 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical; Abortion, FetusStudies 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400358
- Sponsor's protocol ID
- 2016/12.5
- Status last verified
- Mar 2018
- First submitted
- 6 Jan 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterocervical Angle in the Termination of Second Trimester Pregnancy in Multiparous Women
- ClinicalTrials.gov ID
- NCT03400358
- Acronym / sponsor ID
- 2016/12.5
- Keywords
- uterocervical angle, multiparous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 17 Jan 2018 (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.
To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women.
Detailed description
Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.
The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on multiparous women who are taking Foley baloon for the cervical preparation and aim to measure their UCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical abortion | – | Other: uterocervical angle150 singleton multiparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were multiparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Multiparous pregnant women undergoing medical abortion in the second trimester
Key inclusion criteria (2 listed)
- multiparous singleton pregnancy
- no previous systemic illnesses
Key exclusion criteria (3 listed)
- abnormal Pap smear
- history of dilatation and curettage (D\&C)
- history of LEEP and cervical conization
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 |
|---|---|---|
| uterocervical anglethe angle between cervical canal and anterior uterine wall is measured sonographically. | Other | Medical abortion |
Primary outcome
uterocervical angle
Time frame: 1 week
the angle between the cervical canal and anterior uterine wall
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 6 Mar 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 Medical; Abortion, Fetus and Second Trimester Abortion, run by Kanuni Sultan Suleyman Training 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 3 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 6 Mar 2018. 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?
uterocervical angle (time frame: 1 week). 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 6 Mar 2018.