Status:
COMPLETED
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pregnancy Complications
Eligibility:
FEMALE
18-48 years
Phase:
PHASE4
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.
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00190294
Start Date
April 1 2003
End Date
September 1 2006
Last Update
May 2 2011
Active Locations (1)
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1
Poissy Hospital
Poissy, France, 78303