The Efficacy of Early Amniotomy for Induction of Labor

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00133016

Enrollment

Registered

2005-08-22

Start date

2006-08-31

Completion date

2006-08-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Induced

Keywords

Induction of labor

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.

Interventions

PROCEDUREAmniotomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Inclusion criteria

* 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

Exclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026