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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190294
First received: September 13, 2005
Last updated: April 29, 2011
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Pregnancy Complications
 Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of surgical evacuation in each group [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    Number of surgical evacuation in each group


Enrollment: 200
Study Start Date: April 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MIFEPRISTONE 200 mg and misoprostol 400 µg
 Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg
MIFEPRISTONE 200 mg and misoprostol 400 µg
Other Name: MIFEPRISTONE 200 mg and misoprostol 400 µg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190294

Locations
France
Poissy Hospital
Poissy, France, 78303
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Patrick Rosenberg Poissy Hospital
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Isabelle Brindel, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00190294     History of Changes
Other Study ID Numbers: P011017
Study First Received: September 13, 2005
Last Updated: April 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pregnancy Complications

Additional relevant MeSH terms:
Pregnancy Complications
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
 Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on May 22, 2013