Cervical Length on Pregnancy Termination | NCT04013035

Studies
Cervical Length on Pregnancy Termination

NCT04013035

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Jul 10, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Pregnancy Loss

Interventions

cervical length measurement

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

Jul 2019

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

Jan 1, 2016Actual

Primary Completion Date

Jun 1, 2017Actual

Completion Date

Jun 1, 2017Actual

First Submitted Date

Jul 7, 2019

First Submission Date that Met QC Criteria

Jul 7, 2019

First Posted Date

Jul 9, 2019Actual

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

Jul 8, 2019

Last Update Posted Date

Jul 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pınar Kadirogulları, principal investigator, M.D, Department of Obstetrics and Gynecology, 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

Cervical length is used as a parameter to predict cervical insufficiency and onset of labor. However, its role in predicting abortion induction is unclear.To investigate the impact of cervical length measurement and fetal viability on second trimester pregnancy termination duration in nulliparous pregnant women.

Detailed Description

Cervical length and fetal viability were evaluated prior to second trimester pregnancy termination due to various indications. nulliparous pregnant women through 13 and 26 gestational weeks in whom pregnancy termination was conducted within 72 hours after admission were included in the study. The subjects were grouped into two groups according to fetal viability.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cervical length measurement	Procedure	cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cervical length measurement	cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women. The measurements will be saved as a number in cm.	2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Nulliparous pregnant women at 13-26 weeks of gestation

Exclusion Criteria:

Patients with multiple gestations,
multiparous patients or
patients that had uterine gynecologic surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Nulliparous pregnant women at 13-26 weeks of gestation will be included in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni Sultan Süleyman Training and Research Hospital		Istanbul		33404	Turkey (Türkiye)