Termination of Pregnancy With Mifepristone and Misoprosto... | NCT00206193

Studies
Termination of Pregnancy With Mifepristone and Misoprostol Versus Sulprostone

NCT00206193

Sponsor

Atrium Medical Center

Status

Unknown status

Last Update Posted

Oct 30, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Abortion, Induced

Interventions

mifepristone
misoprostol
sulprostone

Countries

Netherlands

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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 29, 2007

Last Update Posted Date

Oct 30, 2007Estimated

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women by whom a termination of pregnancy is desired.

Exclusion Criteria:

Women with liver/kidney disease
Women on long-term use of corticosteroids (> 6 months)
Cardiovascular problems
Therapy-resistant diabetic women
Therapy-resistant asthma/bronchitis
Thalassemia
Ulcerative colitis
Peptic ulcer disease
Glaucoma
Porphyria
Allergic reaction to prostaglandin or mifepristone
Women with a prior caesarian section or women with contractions at the start of the study

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suzanne HW Vonken, Dr.	Contact	003145-5766666	466825	svonken@gmail.com
F Roumen, Dr.	Contact	003145-5766666	466509

Overall Officials

Name	Affiliation	Role
F Roumen, Dr.	Atrium Medisch Centrum, Heerlen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atrium Medisch Centrum	Recruiting	Heerlen	Limburg		Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
D015735	Mifepristone
D016595	Misoprostol
C016767	sulprostone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
mifepristone	Drug
misoprostol	Drug
sulprostone	Drug