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

NCT ID: NCT00190294

Last Updated: 2011-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Pregnancy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MIFEPRISTONE 200 mg and misoprostol 400 µg

Group Type EXPERIMENTAL

MIFEPRISTONE 200 mg and misoprostol 400 µg

Intervention Type DRUG

MIFEPRISTONE 200 mg and misoprostol 400 µg

Interventions

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MIFEPRISTONE 200 mg and misoprostol 400 µg

MIFEPRISTONE 200 mg and misoprostol 400 µg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of developpement

Principal Investigators

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Patrick Rosenberg

Role: STUDY_CHAIR

Poissy Hospital

Locations

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Poissy Hospital

Poissy, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 34061352 (View on PubMed)

Torre A, Huchon C, Bussieres L, Machevin E, Camus E, Fauconnier A. Immediate versus delayed medical treatment for first-trimester miscarriage: a randomized trial. Am J Obstet Gynecol. 2012 Mar;206(3):215.e1-6. doi: 10.1016/j.ajog.2011.12.009. Epub 2011 Dec 16.

Reference Type DERIVED
PMID: 22381604 (View on PubMed)

Other Identifiers

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P011017

Identifier Type: -

Identifier Source: org_study_id

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