NCT00133016

Brief Summary

The purpose of this clinical trial is to investigate the efficacy of early amniotomy on reducing both the duration of labor and the frequency of dystocia in nulliparous women undergoing an induction of labor. This research project is a prospective, parallel clinical trial, in which subjects are randomized into one of two treatment groups: those who undergo early amniotomy and those who do not undergo early artificial rupture of the amniotic membranes.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

August 19, 2005

Last Update Submit

December 1, 2015

Conditions

Labor, Induced

Keywords

Induction of labor

Interventions

AmniotomyPROCEDURE

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age \> 37 weeks (using established National Institute of Child Health and Human Development \[NICHD\] dating criteria)
  • Nulliparous (i.e., first term pregnancy)
  • Admitted to the hospital for induction of labor
  • Singleton pregnancy
  • Fetal head applied to the cervix
  • The ability to understand the requirements of the study, as determined by the study nurse

You may not qualify if:

  • Premature rupture of amniotic membranes
  • Cervical dilation \> 4 cm
  • Vaginal bleeding
  • Major fetal abnormalities that are known at time of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Amniotomy

Intervention Hierarchy (Ancestors)

Labor, InducedDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • George A. Macones, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

August 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)