Uterocervical Angle in Idiopathic Polyhydramnios

• Sponsor: Nefise Nazlı YENIGUL (Other)
• Overall Status: Completed
• CT.gov ID: NCT03828695
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor	Other: uterocervical angle	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Efficacy and Efficiency of Uterocervical Angle for Prediction of Preterm Labor in Patients With Idiopathic Polyhydramnios: a Prospective Cohort Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: uterocervical angle uterocervical angle is the angle between lower segment of uterus and cervix	Other: uterocervical angle; uterocervical angle is the angle between lower segment of uterus and cervix

Outcome Measures

Primary Outcome Measures

1. prediction of preterm birth by uterocervical angle in patients with idiopathic polyhydramnios. [6 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nefise N YENIGUL	Sanlıurfa		Turkey

Sponsors and Collaborators

• Nefise Nazlı YENIGUL

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT03828695
• Other Study ID Numbers: 10988
• First Posted: Feb 4, 2019
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature; Polyhydramnios

Study Results

No Results Posted as of Jul 23, 2019