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NCT00393731 Clinical Trial

A Randomized, Control Trial for Preinduction Cervical Ripening

Labor, Induced Clinical Trial

Official title:
A Randomized, Control Trial for Preinduction Cervical Ripening

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00393731
Other study ID # HSC-MS-04-008
Secondary ID
Status Completed
Phase Phase 2
First received October 26, 2006
Last updated January 11, 2008
Start date January 2004
Est. completion date August 2007

Study information
Verified date January 2008
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Recruitment information / eligibility
Status Completed
Enrollment 540
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women that are hospitalized for induction of labor that have a Bishop's score <5

- singleton gestation

- cephalic presentation

- 24 weeks gestational age

Exclusion Criteria:

- Prior uterine surgery

- malpresentation

- placenta previa or abruption

- clinically suspected or diagnosed intra amniotic infection

- genital HSV infection

- multiple gestation

- premature rupture of the membranes

- active labor

- maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol

• oxytocin

Locations
Country Name City State
United States Lyndon B. Johnson Hospital Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vaginal Delivery rates
Secondary Time interval to delivery
See also
  Status Clinical Trial Phase
Recruiting NCT02902653 - Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction Phase 4
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 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
Completed NCT05885087 - 'Extended Balloon Catheter' Labour Induction; a Single Arm Pilot Trial' N/A