NCT00383032

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
Last Updated

October 24, 2023

Status Verified

December 1, 2007

First QC Date

September 28, 2006

Last Update Submit

October 23, 2023

Conditions

Abortion, Induced

Outcome Measures

Primary Outcomes (1)

  • induction to delivery time

Secondary Outcomes (4)

  • pain

  • delivery within 24 hours

  • need for post-partum D&C

  • adverse events

Interventions

mifepristoneDRUG

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation
  • age greater than 16
  • able to speak English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4.

    PMID: 17963864DERIVED

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Karen George, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 28, 2006

First Posted

October 2, 2006

Study Start

January 1, 2004

Study Completion

June 1, 2006

Last Updated

October 24, 2023

Record last verified: 2007-12

Locations

US(1)