NCT04095507

Brief Summary

To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 17, 2019

Last Update Submit

September 18, 2019

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes

    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.

    7 month]

Study Arms (1)

uterocervical angle

OTHER

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

Diagnostic Test: uterocervical angle

Interventions

uterocervical angleDIAGNOSTIC_TEST

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

uterocervical angle

Eligibility Criteria

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

You may qualify if:

  • no previous systemic illnesses
  • Preterm Premature Rupture of the Membranes

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)

Sanliurfa Traning and Research Hospital

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
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

January 1, 2019

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Locations

TU(1)