Uterocervical Angle in the Termination of Second Trimeste... | NCT03220607

Studies
Uterocervical Angle in the Termination of Second Trimester Pregnancy

NCT03220607

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Sep 6, 2017Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Abortion, Second Trimester

Interventions

uterocervical angle

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2016Actual

Primary Completion Date

Aug 30, 2017Actual

Completion Date

Sep 1, 2017Actual

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Jul 14, 2017

First Posted Date

Jul 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2017

Last Update Posted Date

Sep 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Berna Aslan Cetin, MD,ObGYN, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the performance of uterocervical angle (UCA) in the prediction of second trimester terminations.

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 nulliparous women who are taking misoprostol for the cervical preparation and aim to measure their UCA.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical induced abortion		120 singleton nulliparous patients are planning to complete the study period. Study group constitute of second trimester pregnancies between 14-24 weeks of gestation. All participants were nulliparous and had no systemic illnesses. The uterocervical angle will be measured in all participants before the induction of labor.	Other: uterocervical angle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uterocervical angle	Other	uterocervical angle is the angle between lower segment of uterus and cervix	Medical induced abortion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
uterocervical angle	the angle between the lower segment of uterus and cervix	once at the beginning of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nulliparous singleton pregnancy
no previous systemic illnesses

Exclusion Criteria:

abnormal Pap smear
previous cesarean section
history of dilatation and curettage (D&C)
history of LEEP and cervical conization

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant population undergoing second trimester abortion

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Pregnant population undergoing medical induced second trimester abortion.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alev Atis, MD,ObGyn	Kanuni Sultan Suleyman Training and Research Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni SSTRH		Istanbul		34303	Turkey (Türkiye)

References Module

Citations

Not provided