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NCT00133016 Clinical Trial

The Efficacy of Early Amniotomy for Induction of Labor

Labor, Induced Clinical Trial

Official title:
The Efficacy of Early Amniotomy for Induction of Labor

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00133016
Other study ID # 701340
Secondary ID
Status Withdrawn
Phase N/A
First received August 19, 2005
Last updated December 1, 2015
Start date August 2006
Est. completion date August 2006

Study information
Verified date December 2015
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Procedure:
• Amniotomy

Locations
Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

See also
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Completed NCT05100264 - Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction N/A
Completed NCT01962831 - Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter N/A
Recruiting NCT05857059 - Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration N/A
Completed NCT03665688 - Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® N/A
Completed NCT00992524 - Oral Titrated Misoprostol for Induction of Labour N/A
Completed NCT00259103 - Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor Phase 2
Completed NCT04755218 - Labor Induction With Oral Versus Vaginal Misoprostol
Completed NCT04746248 - Outpatient Labor Induction Using Oral Misoprostol in Norway N/A
Completed NCT05838313 - Should I Have an Elective Induction? N/A
Completed NCT03140488 - Oxytocin Dosage to Decrease Induction Duration Phase 4
Recruiting NCT02486679 - A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction Phase 4
Terminated NCT01641601 - Prehospital Cervical Ripening Before Induction and the Maternal Experience N/A
Completed NCT00465998 - Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor N/A
Completed NCT00393731 - A Randomized, Control Trial for Preinduction Cervical Ripening Phase 2
Completed NCT00545194 - Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess Phase 3
Completed NCT05874024 - Induction of Labour With a Double Balloon Catheter
Completed NCT03407625 - Foley Bulb With Oral Misoprostol for Induction of Labor N/A
Completed NCT04731896 - Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 N/A
Terminated NCT02373800 - Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation