Uterocervical Angle: a Screening Tool That Estimates the... | NCT04848701

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

NCT04848701

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status

Completed

Last Update Posted

Apr 19, 2021Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Post Term Pregnancy

Interventions

latent phase duration
uterocervical angle (UCA)

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Oct 30, 2020Actual

First Submitted Date

Apr 9, 2021

First Submission Date that Met QC Criteria

Apr 13, 2021

First Posted Date

Apr 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecolog, Sanliurfa Mehmet Akif Inan Education and Research HospitalPrincipal Investigator

Lead Sponsor

Sanliurfa Mehmet Akif Inan Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
uterocervical angle	Other	uterocervical angle is the angle between lower segment of uterus and cervix	Other: latent phase duration Other: uterocervical angle (UCA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
latent phase duration	Other	latent phase duration in post term pregnancies	uterocervical angle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nefise Nazlı Yenigül		Bursa		16110	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011273	Pregnancy, Prolonged

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided