Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes

• Sponsor: Nefise Nazlı YENIGUL (Other)
• Overall Status: Completed
• CT.gov ID: NCT04095507
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 11.6

Study Details

Study Description

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Efficacy and Efficiency of Uterocervical Angle for Prediction of Labor Timing in Patients With Preterm Premature Rupture of the Membranes: a Prospective Cohort Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jul 30, 2019
• Actual Study Completion Date: Jul 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. prediction of birth timing by uterocervical angle in patients with Preterm Premature Rupture of the Membranes [7 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:

• no previous systemic illnesses

• Preterm Premature Rupture of the Membranes

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	Sanliurfa Traning and Research Hospital	Şanlıurfa		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, Principal Investigator, Sanliurfa Mehmet Akif Inan Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT04095507
• Other Study ID Numbers: 10987
• First Posted: Sep 19, 2019
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 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; Rupture

Study Results

No Results Posted as of Sep 20, 2019