NCT03784092

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

December 19, 2018

Last Update Submit

December 20, 2018

Conditions

Labor Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

  • time to delivery

    time from extra amniotic catheter placement till delivery

    labor ( catheter placement till delivery completion)

Study Arms (2)

control

NO INTERVENTION

feedback

EXPERIMENTAL
Other: feedback

Interventions

feedbackOTHER

feedback by electronic pedometers regarding patient mobility while undergoing labor induction

feedback

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share