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Completed

NCT Number: NCT00190294

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

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.

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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Poissy Hospital

Poissy, 78303, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIFEPRISTONE 200 mg and misoprostol 400 µg

Drug

MIFEPRISTONE 200 mg and misoprostol 400 µg

Primary outcomes

  1. Number of surgical evacuation in each group

    Time frame: during de study

    Number of surgical evacuation in each group

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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