NCT04848701

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 9, 2021

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months

Secondary Outcomes (1)

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

    5 months

Study Arms (1)

uterocervical angle

OTHER

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

Other: latent phase durationOther: uterocervical angle (UCA)

Interventions

latent phase duration in post term pregnancies

uterocervical angle

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

uterocervical angle

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise Nazlı Yenigül

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Assistant Professor Department of Obstetrics and Gynecolog

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 19, 2021

Study Start

June 1, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations