Abortion, Second TrimesterNCT03220607
Uterocervical Angle in the Termination of Second Trimester Pregnancy
An observational study of Abortion, Second Trimester, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the performance of uterocervical angle (UCA) in the prediction of second trimester terminations. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Second Trimester
- What is being tested?
- uterocervical angle
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2016to 1 Sep 2017
- How long will I take part?
- 4 Days
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant population undergoing medical induced second trimester abortion.
Who may be able to join
- Nulliparous singleton pregnancy
- no previous systemic illnesses
Who cannot join
- abnormal Pap smear
- previous cesarean section
- 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: The Predictive Performance of Uterocervical Angle in the Termination of Second Trimester Pregnancy
To evaluate the performance of uterocervical angle (UCA) in the prediction of second trimester terminations.
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 nulliparous women who are taking misoprostol for the cervical preparation and aim to measure their UCA.
- Conditions
- Abortion, Second Trimester
- Being tested
- uterocervical angle
- Keywords
- uterocervical angle, second trimester abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterocervical angleOther
uterocervical angle is the angle between lower segment of uterus and cervix
| Study group | Role | What they receive |
|---|---|---|
| Medical induced abortion | 120 singleton nulliparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were nulliparous 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 lower segment of uterus and cervix
Measured: once at the beginning of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start15 Oct 2016
- Primary completion30 Aug 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, Second TrimesterStudies 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
- 120 participants (actual)
- Target duration
- 4 Days
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
- Investigators
- Alev Atis, MD,ObGyn, Study director, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220607
- Sponsor's protocol ID
- 2016/5
- Status last verified
- Sep 2017
- First submitted
- 14 Jul 2017
- Last updated
- 6 Sep 2017
- 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 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Performance of Uterocervical Angle in the Termination of Second Trimester Pregnancy
- ClinicalTrials.gov ID
- NCT03220607
- Acronym / sponsor ID
- 2016/5
- Conditions
- Abortion, Second Trimester
- Keywords
- uterocervical angle, second trimester abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 18 Jul 2017 (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 performance of uterocervical angle (UCA) in the prediction of second trimester terminations.
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 nulliparous women who are taking misoprostol for the cervical preparation and aim to measure their UCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical induced abortion | – | Other: uterocervical angle120 singleton nulliparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were nulliparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant population undergoing medical induced second trimester abortion.
Key inclusion criteria (2 listed)
- Nulliparous singleton pregnancy
- no previous systemic illnesses
Key exclusion criteria (4 listed)
- abnormal Pap smear
- previous cesarean section
- 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 angleuterocervical angle is the angle between lower segment of uterus and cervix | Other | Medical induced abortion |
Primary outcome
uterocervical angle
Time frame: once at the beginning of enrollment
the angle between the lower segment of uterus and cervix
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 Sep 2017.
- Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Abortion, Second Trimester
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 4
Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Abortion, Dilation and Evacuation
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
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.
Alev Atis, MD,ObGyn study director
Kanuni Sultan Suleyman Training and Research Hospital
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 Abortion, Second Trimester, 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 4 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 Sep 2017. 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: once at the beginning of enrollment). 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 Sep 2017.