Back to resultsExpectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Primary Purpose
Pregnancy Complications
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MIFEPRISTONE 200 mg and misoprostol 400 µg
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Complications focused on measuring Pregnancy Complications
Eligibility Criteria
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
Sites / Locations
- Poissy Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
MIFEPRISTONE 200 mg and misoprostol 400 µg
Outcomes
Primary Outcome Measures
Number of surgical evacuation in each group
Number of surgical evacuation in each group
Secondary Outcome Measures
Full Information
NCT ID
NCT00190294
First Posted
September 13, 2005
Last Updated
April 29, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00190294
Brief Title
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Official Title
Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications
Keywords
Pregnancy Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MIFEPRISTONE 200 mg and misoprostol 400 µg
Intervention Type
Drug
Intervention Name(s)
MIFEPRISTONE 200 mg and misoprostol 400 µg
Intervention Description
MIFEPRISTONE 200 mg and misoprostol 400 µg
Primary Outcome Measure Information:
Title
Number of surgical evacuation in each group
Description
Number of surgical evacuation in each group
Time Frame
during de study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Rosenberg
Organizational Affiliation
Poissy Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Poissy Hospital
City
Poissy
ZIP/Postal Code
78303
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34061352
Citation
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.
Results Reference
derived
PubMed Identifier
22381604
Citation
Torre 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.
Results Reference
derived
Learn more about this trial
Expectant Versus Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
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