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NCT00383032 Clinical Trial

Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

Abortion, Induced Clinical Trial

Official title:
Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00383032
Other study ID # CPHS # 16429
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2004
Est. completion date June 2006

Study information
Verified date December 2007
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility Inclusion Criteria: - pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation - age greater than 16 - able to speak English Exclusion Criteria: - prior uterine scar or - allergy or history of bad reaction to any of the study drugs or - history of chronic adrenal failure or - porphyria or - concurrent long-term corticosteroid treatment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• mifepristone

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary induction to delivery time
Secondary pain
Secondary delivery within 24 hours
Secondary need for post-partum D&C
Secondary adverse events
See also
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Completed NCT02485444 - Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion Phase 4
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Recruiting NCT02480543 - Different Routes of Misoprostol Prior to First Trimester Surgical Abortion Phase 4
Completed NCT00870272 - Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP) N/A
Completed NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3