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

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 4

Conditions

Pregnancy Complications

Treatments

Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg

Study type

Interventional

Funder types

Other

Identifiers

NCT00190294
P011017

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 1 patient group

1
Experimental group
Description:
MIFEPRISTONE 200 mg and misoprostol 400 µg
Treatment:
Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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