Cervical Length Pre-induction as a Tool to Predict Vagina... | NCT02916082

Studies
Cervical Length Pre-induction as a Tool to Predict Vaginal Birth

NCT02916082

Sponsor

Saint Thomas Hospital, Panama

Status

Completed

Last Update Posted

Sep 27, 2016Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Cervical Length Measurement
Pregnancy, Prolonged

Interventions

Cervical length measurement

Countries

Panama

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 2016

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

Nov 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Sep 25, 2016

First Submission Date that Met QC Criteria

Sep 25, 2016

First Posted Date

Sep 27, 2016Estimated

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 25, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, PanamaPrincipal Investigator

Lead Sponsor

Saint Thomas Hospital, PanamaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 value of measuring cervical length as a predictor of vaginal birth after induction of labor with prostaglandins in pregnancies with 41 weeks of gestation.

Detailed Description

Not provided

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prolonged pregnancy		Pregnancies with 41 weeks or more of gestation determined by a reliable last menstrual period or early fetal ultrasound.	Procedure: Cervical length measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cervical length measurement	Procedure	Vaginal ultrasound to measure cervical length previous to use of prostaglandins.	Prolonged pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal Birth	Number of vaginal births obtained after a measure of cervical length below 2,5 cms.	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Induction to delivery time	Time (hours) between the application of a prostaglandin and termination of pregnancy (vaginal or cesarean).	72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

41 weeks or more of gestational age
Cervical length measured by a FMF certified physician

Exclusion Criteria:

Any condition that could interfere with a possible vaginal birth (previous cesarean section, hypertensive disorders of pregnancies).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnancies with a gestational age of 41 weeks or more.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Thomas H		Panama City	Provincia de Panamá		Panama

Condition Browse Module

MeSH Terms

ID	Term
D011273	Pregnancy, Prolonged

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided