Expectant Versus Immediate Medical Management for the Eva... | NCT00190294

Studies
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW

NCT00190294

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

May 2, 2011Estimated

Enrollment

200Actual

Phase

Phase 4

Conditions

Pregnancy Complications

Interventions

MIFEPRISTONE 200 mg and misoprostol 400 µg

Countries

France

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

Mar 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

Apr 2003

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 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

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.

Detailed Description

Randomized control trial comparing one week expectancy vs immediate medical treatment (mifepristone 200mg and misoprostol 400ug) in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	MIFEPRISTONE 200 mg and misoprostol 400 µg	Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MIFEPRISTONE 200 mg and misoprostol 400 µg	Drug	MIFEPRISTONE 200 mg and misoprostol 400 µg	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of surgical evacuation in each group	Number of surgical evacuation in each group	during de study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Agreed women aged over 18 yrs old

Non evolutive pregnancy before 13GW :

Non evolutive pregnancy with no fetal cardiac activity
Non evolutive pregnancy with embryonic structures
Trophoblastic material in uterine cavity P bhCG < 10UI/L

Exclusion criteria:

Age < 18 years
pregnancy evolutionary
not evolutionary pregnancy after 13 weeks of amenorrhoea characterized by the presence of an scan image intra-uterine ANECHOGENE furthermore of 50mm of diameter
amenorrhoea of more than 13 weeks
pregnancy twin
pregnancy molar
pregnancy extra-uterine
Extra-uterine pregnancy
one or many contraindications in the mifepristone:
Allergy known about the MIFEPRISTONE
Incapacity suprarenal
corticosteroid therapy in the long price
confusions of the haemostasis (thrombopenia < in 100000 / mm3)
anaemia (rate Hg < in 9 g / dl)
contraindication in the misoprostol
allergy known about PROSTAGLANDINES
BEANCE cervical

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Patrick Rosenberg	Poissy Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Poissy Hospital		Poissy		78303	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34061352	Derived	Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
22381604	Derived

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D015735	Mifepristone
D016595	Misoprostol

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