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

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ClinicalTrials.gov Identifier: NCT00190294
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Pregnancy Complications Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Study Start Date : April 2003
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
MIFEPRISTONE 200 mg and misoprostol 400 µg
Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg
MIFEPRISTONE 200 mg and misoprostol 400 µg




Primary Outcome Measures :
  1. Number of surgical evacuation in each group [ Time Frame: during de study ]
    Number of surgical evacuation in each group



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190294


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

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
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: March 2007

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

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