Post Term PregnancyNCT04848701
Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies
A study testing latent phase duration and uterocervical angle (UCA) in people with Post Term Pregnancy, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase duration in post term pregnancies 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
- Post Term Pregnancy
- What is being tested?
- latent phase duration and uterocervical angle (UCA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 30 Oct 2020
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with singleton pregnancies
- Post term pregnancies
- Patients with vertex presentation,
- Patients with intact membranes
- Patients with no uterine contractions
Who cannot join
- women with BMI >30,
- multiparity and multiple pregnancies,
- patients with macrosomia (>4500 gr),
- patients with major fetal congenital abnormality or fetal death and any contraindications to vaginal birth (e.g. active genital herpes),
- patients with abnormal Pap smears,
- patients with a history of previous cesarean section, myomectomy, hysteroscopic surgeries, dilatation and curettages, loop electrosurgical excision procedures, and cervical conization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Uterocervical Angle for Latent Phase Duration in Post Term Pregnancies
To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase duration in post term pregnancies
- Conditions
- Post Term Pregnancy
- Being tested
- latent phase duration, uterocervical angle (UCA)
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latent phase durationOther
latent phase duration in post term pregnancies
uterocervical angle (UCA)Other
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: Other: latent phase duration; Other: uterocervical angle (UCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of latent phase duration by uterocervical angle in post term pregnancies
In patients diagnosed with late term pregnancy, the uterocervical angle and cervical length were measured by transvaginal ultrasound (TVUS) at the time of admission to the delivery room before labor induction.
Measured: 5 months
Secondary outcomes (1)
the relative success of UCA in active phase and duration of labor prediction in post term pregnancies
5 months
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jun 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Term PregnancyStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
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
- NCT04848701
- Sponsor's protocol ID
- 20.11.31
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Uterocervical Angle for Latent Phase Duration in Post Term Pregnancies
- ClinicalTrials.gov ID
- NCT04848701
- Acronym / sponsor ID
- 20.11.31
- Conditions
- Post Term Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 19 Apr 2021 (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 latent phase duration in post term pregnancies
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uterocervical angle | Other | Other: latent phase duration, Other: uterocervical angle (UCA)uterocervical angle is the angle between lower segment of uterus and cervix |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with singleton pregnancies
- Post term pregnancies
- Patients with vertex presentation,
- Patients with intact membranes
- Patients with no uterine contractions
Key exclusion criteria (6 listed)
- women with BMI >30,
- multiparity and multiple pregnancies,
- patients with macrosomia (>4500 gr),
- patients with major fetal congenital abnormality or fetal death and any contraindications to vaginal birth (e.g. active genital herpes),
- patients with abnormal Pap smears,
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 |
|---|---|---|
| latent phase durationlatent phase duration in post term pregnancies | Other | uterocervical angle |
| uterocervical angle (UCA)uterocervical angle is the angle between lower segment of uterus and cervix | Other | uterocervical angle |
Primary outcome
prediction of latent phase duration by uterocervical angle in post term pregnancies
Time frame: 5 months
In patients diagnosed with late term pregnancy, the uterocervical angle and cervical length were measured by transvaginal ultrasound (TVUS) at the time of admission to the delivery room before labor induction.
1 secondary outcome
the relative success of UCA in active phase and duration of labor prediction in post term pregnancies
Time frame: 5 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 19 Apr 2021.
- Individual participant dataSharing planned: No
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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 latent phase duration and uterocervical angle (UCA) in people with Post Term Pregnancy, 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 5 inclusion and 6 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 19 Apr 2021. 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 latent phase duration by uterocervical angle in post term pregnancies (time frame: 5 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 19 Apr 2021.