Effect Mobility During Induction of Labor on Time to Deli... | NCT03784092

Studies
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial

NCT03784092

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Dec 21, 2018Actual

Enrollment

224Estimated

Phase

Not Applicable

Conditions

Labor Onset and Length Abnormalities

Interventions

feedback

Countries

Not provided

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2019Estimated

Primary Completion Date

Jan 2021Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 20, 2018

First Posted Date

Dec 21, 2018Actual

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

Dec 20, 2018

Last Update Posted Date

Dec 21, 2018Actual

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

this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

224Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	No Intervention
feedback	Experimental		Other: feedback

Interventions

Name	Type	Description	Arm Group Labels	Other Names
feedback	Other	feedback by electronic pedometers regarding patient mobility while undergoing labor induction	feedback

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to delivery	time from extra amniotic catheter placement till delivery	labor ( catheter placement till delivery completion)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women
low risk pregnancies
singlelton
vertex position
undergoing labor induction with extra amniotic catheter
no contraindication for enhanced mobility

Exclusion Criteria:

medical recommendation for limited mobility
status post cesarean delivery
twin pregnancy
premature rupture of membranes
severe preeclampsia
maternal comorbidity

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided