Mifepristone Versus Laminaria for Cervical Ripening in Mi... | NCT00383032

Studies
Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

NCT00383032

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Completed

Last Update Posted

Oct 24, 2023Actual

Enrollment

Phase

Not Applicable

Conditions

Abortion, Induced

Interventions

mifepristone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Jun 2006

First Submitted Date

Sep 28, 2006

First Submission Date that Met QC Criteria

Sep 29, 2006

First Posted Date

Oct 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2023

Last Update Posted Date

Oct 24, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
mifepristone	Drug

Measure	Description	Time Frame
induction to delivery time

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen George, MD	Dartmouth-Hitchcock Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth-Hitchcock Medical Center		Lebanon	New Hampshire	03756	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17963864	Derived	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.

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Measure	Description	Time Frame
pain
delivery within 24 hours
need for post-partum D&C