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

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190294
• Other study ID #: P011017
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 29, 2011
• Start date: April 2003
• Est. completion date: September 2006

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Drug:
• MIFEPRISTONE 200 mg and misoprostol 400 µg
MIFEPRISTONE 200 mg and misoprostol 400 µg

Locations

Country	Name	City	State
France	Poissy Hospital	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of surgical evacuation in each group	Number of surgical evacuation in each group	during de study	Yes