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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190294

Enrollment

200

Registered

2005-09-19

Start date

2003-04-30

Completion date

2006-09-30

Last updated

2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Complications

Keywords

Pregnancy Complications

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.

Interventions

DRUGMIFEPRISTONE 200 mg and misoprostol 400 µg

MIFEPRISTONE 200 mg and misoprostol 400 µg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Number of surgical evacuation in each group	during de study	Number of surgical evacuation in each group

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026