Uterocervical Angle in the Pregnancy Termination of Multiparous Women

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03400358
• Collaborator: (none)
• Enrollment: 148
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 36.6

Study Details

Study Description

Brief Summary

To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women.

Condition or Disease	Intervention/Treatment	Phase
Medical; Abortion, Fetus; Second Trimester Abortion	Other: uterocervical angle

Detailed Description

Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on multiparous women who are taking Foley baloon for the cervical preparation and aim to measure their UCA.

Study Design

• Study Type: Observational
• Actual Enrollment: 148 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Uterocervical Angle in the Termination of Second Trimester Pregnancy in Multiparous Women
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Jan 31, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Medical abortion 150 singleton multiparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were multiparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor.	Other: uterocervical angle; the angle between cervical canal and anterior uterine wall is measured sonographically.

Outcome Measures

Primary Outcome Measures

1. uterocervical angle [1 week]

   the angle between the cervical canal and anterior uterine wall

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• multiparous singleton pregnancy

• no previous systemic illnesses

Exclusion Criteria:

• abnormal Pap smear

• history of dilatation and curettage (D&C)

• history of LEEP and cervical conization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni SSTRH	Istanbul		Turkey

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Berna Aslan Cetin, Md, ObGYN, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03400358
• Other Study ID Numbers: 2016/12.5
• First Posted: Jan 17, 2018
• Last Update Posted: Mar 6, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Berna Aslan Cetin, Md, ObGYN, Kanuni Sultan Suleyman Training and Research Hospital: uterocervical angle; multiparous

Study Results

No Results Posted as of Mar 6, 2018