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
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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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2003-04-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
MIFEPRISTONE 200 mg and misoprostol 400 µg
MIFEPRISTONE 200 mg and misoprostol 400 µg
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
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
48 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
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
Countries
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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.
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.
Other Identifiers
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P011017
Identifier Type: -
Identifier Source: org_study_id
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