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Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies

Primary Purpose

Post Term Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
latent phase duration
uterocervical angle (UCA)
Sponsored by
Sanliurfa Mehmet Akif Inan Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Post Term Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with singleton pregnancies
  • Post term pregnancies
  • Patients with vertex presentation,
  • Patients with intact membranes
  • Patients with no uterine contractions

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nefise Nazlı Yenigül

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

uterocervical angle

Arm Description

uterocervical angle is the angle between lower segment of uterus and cervix

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the relative success of UCA in active phase and duration of labor prediction in post term pregnancies
5 months

Full Information

First Posted
April 9, 2021
Last Updated
April 13, 2021
Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04848701
Brief Title
Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies
Official Title
Anterior Uterocervical Angle for Latent Phase Duration in Post Term Pregnancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase duration in post term pregnancies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Term Pregnancy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
uterocervical angle
Arm Type
Other
Arm Description
uterocervical angle is the angle between lower segment of uterus and cervix
Intervention Type
Other
Intervention Name(s)
latent phase duration
Intervention Description
latent phase duration in post term pregnancies
Intervention Type
Other
Intervention Name(s)
uterocervical angle (UCA)
Intervention Description
uterocervical angle is the angle between lower segment of uterus and cervix
Primary Outcome Measure Information:
Title
prediction of latent phase duration by uterocervical angle in post term pregnancies
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
the relative success of UCA in active phase and duration of labor prediction in post term pregnancies
Description
5 months
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with singleton pregnancies Post term pregnancies Patients with vertex presentation, Patients with intact membranes Patients with no uterine contractions Exclusion Criteria: 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.
Facility Information:
Facility Name
Nefise Nazlı Yenigül
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies

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