Preterm LaborNCT04095507
Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes
A study testing uterocervical angle in people with Preterm Labor, run by Nefise Nazlı YENIGUL at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes 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
- Preterm Labor
- What is being tested?
- uterocervical angle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Jul 2019
- Phase
- Interventional
- 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
Who may be able to join
- no previous systemic illnesses
- Preterm Premature Rupture of the Membranes
Who cannot join
- abnormal Pap smear
- previous cesarean section
- history of dilatation and curettage (D\&C)
- history of loop electrosurgical excision procedure (LEEP) and cervical conization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Traning and Research Hospital
Sanliurfa
About this study
Official title: Efficacy and Efficiency of Uterocervical Angle for Prediction of Labor Timing in Patients With Preterm Premature Rupture of the Membranes: a Prospective Cohort Study
To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes
- Conditions
- Preterm Labor
- Being tested
- uterocervical angle
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterocervical angleDiagnostic test
uterocervical angle is the angle between lower segment of uterus and cervix
| Study group | Role | What they receive |
|---|---|---|
| uterocervical angle | Other | uterocervical angle is the angle between lower segment of uterus and cervix Receives: Diagnostic Test: uterocervical angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes
During the study period, women were enrolled and uterocervical angle were measured in the first evaluations of polyhydramnios patients in policlinics. Routine pregnancy follow-up was done by our team and weeks of delivery and maternal-fetal outcomes were noted.
Measured: 7 month]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Jan 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nefise Nazlı YENIGUL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095507
- Sponsor's protocol ID
- 10987
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Efficiency of Uterocervical Angle for Prediction of Labor Timing in Patients With Preterm Premature Rupture of the Membranes: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04095507
- Acronym / sponsor ID
- 10987
- Conditions
- Preterm Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nefise Nazlı YENIGULUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 19 Sep 2019 (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 labor timing in patients with preterm premature rupture of the membranes
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| uterocervical angle | Other | Diagnostic Test: uterocervical angleuterocervical angle is the angle between lower segment of uterus and cervix |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- no previous systemic illnesses
- Preterm Premature Rupture of the Membranes
Key exclusion criteria (4 listed)
- abnormal Pap smear
- previous cesarean section
- history of dilatation and curettage (D\&C)
- history of loop electrosurgical excision procedure (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 | Diagnostic test | uterocervical angle |
Primary outcome
prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes
Time frame: 7 month]
During the study period, women were enrolled and uterocervical angle were measured in the first evaluations of polyhydramnios patients in policlinics. Routine pregnancy follow-up was done by our team and weeks of delivery and maternal-fetal outcomes were noted.
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 20 Sep 2019.
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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?
A study testing uterocervical angle in people with Preterm Labor, run by Nefise Nazlı YENIGUL 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 20 Sep 2019. 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?
prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes (time frame: 7 month]). 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 20 Sep 2019.