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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00190294 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
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Scientific title:
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Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00190294 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Patrick Rosenberg |
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Address:
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Telephone:
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Email:
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Affiliation:
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Poissy Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
48 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy Complications
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Intervention(s)
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Drug: MIFEPRISTONE 200 mg and misoprostol 400 µg
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Primary Outcome(s)
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Number of surgical evacuation in each group
[Time Frame: during de study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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