NCT03828695

Brief Summary

To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor in isolated polyhydramnios

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

January 30, 2019

Last Update Submit

July 21, 2019

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

uterocervical angle

OTHER

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

Other: uterocervical angle

Interventions

uterocervical angleOTHER

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

uterocervical angle

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • isolated polyhydramnios pregnancies
  • no previous systemic illnesses

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise N YENIGUL

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy 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
SPONSOR INVESTIGATOR
PI Title
Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 4, 2019

Study Start

January 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

TU(1)