Back to resultsUterocervical Angle in Idiopathic Polyhydramnios
Primary Purpose
Preterm Labor
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
uterocervical angle
Sponsored by
About this trial
This is an interventional screening trial for Preterm Labor
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
Sites / Locations
- Nefise N YENIGUL
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
uterocervical angle
Arm Description
uterocervical angle is the angle between lower segment of uterus and cervix
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03828695
Brief Title
Uterocervical Angle in Idiopathic Polyhydramnios
Official Title
Efficacy and Efficiency of Uterocervical Angle for Prediction of Preterm Labor in Patients With Idiopathic Polyhydramnios: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nefise Nazlı YENIGUL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the performance of uterocervical angle (UCA) in the prediction of preterm labor in isolated polyhydramnios
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uterocervical angle
Arm Type
Other
Arm Description
uterocervical angle is the angle between lower segment of uterus and cervix
Intervention Type
Other
Intervention Name(s)
uterocervical angle
Intervention Description
uterocervical angle is the angle between lower segment of uterus and cervix
Primary Outcome Measure Information:
Title
prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios.
Description
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.
Time Frame
6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Nefise N YENIGUL
City
Sanlıurfa
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Uterocervical Angle in Idiopathic Polyhydramnios
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