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

Phase 4

Completed

• Conditions: Pregnancy Complications
• Interventions: Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg

• Registration Number: NCT00190294
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 before 13 GW.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2007-03
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MIFEPRISTONE 200 mg and misoprostol 400 µg	MIFEPRISTONE 200 mg and misoprostol 400 µg

Primary Outcome Measures

Name	Time	Method
Number of surgical evacuation in each group	during de study	Number of surgical evacuation in each group

Trial Locations

Locations (1)

Poissy Hospital; 🇫🇷 Poissy, France