Uterocervical Angle in Idiopathic Polyhydramnios | NCT03828695

Studies
Uterocervical Angle in Idiopathic Polyhydramnios

NCT03828695

Sponsor

Nefise Nazlı YENIGUL

Status

Completed

Last Update Posted

Jul 23, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Preterm Labor

Interventions

uterocervical angle

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

Jul 2019

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

Jan 1, 2019Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Jan 31, 2019

First Posted Date

Feb 4, 2019Actual

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

Jul 21, 2019

Last Update Posted Date

Jul 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Nefise Nazlı YENIGULOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 preterm labor in isolated polyhydramnios

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

60Actual

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: uterocervical angle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uterocervical angle	Other	uterocervical angle is the angle between lower segment of uterus and cervix	uterocervical angle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios.	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.	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

isolated polyhydramnios pregnancies
no previous systemic illnesses

Exclusion Criteria:

abnormal Pap smear
previous cesarean section
history of dilatation and curettage (D&C)
history of loop electrosurgical excision procedure (LEEP) 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

45 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 N YENIGUL		Sanliurfa			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided