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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2003
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMay 2, 2011
March 1, 2007
3.4 years
September 13, 2005
April 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of surgical evacuation in each group
Number of surgical evacuation in each group
during de study
Study Arms (1)
1
EXPERIMENTALMIFEPRISTONE 200 mg and misoprostol 400 µg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poissy Hospital
Poissy, 78303, France
Related Publications (2)
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PMID: 34061352DERIVEDTorre A, Huchon C, Bussieres L, Machevin E, Camus E, Fauconnier A. Immediate versus delayed medical treatment for first-trimester miscarriage: a randomized trial. Am J Obstet Gynecol. 2012 Mar;206(3):215.e1-6. doi: 10.1016/j.ajog.2011.12.009. Epub 2011 Dec 16.
PMID: 22381604DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patrick Rosenberg
Poissy Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
April 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
May 2, 2011
Record last verified: 2007-03