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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:
ClinicalTrials.gov Identifier:
NCT00190294
First Posted: September 19, 2005
Last Update Posted: May 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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
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

Resource links provided by NLM:


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 ]
    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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: September 13, 2005
First Posted: September 19, 2005
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