Back to resultsIntrarectal Misoprostol in Postpartum Haemorrhage (HEMOSTOP)
Primary Purpose
Postpartum Haemorrhage
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Misoprostol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Haemorrhage
Eligibility Criteria
Inclusion Criteria:
- Older than 18 yrs old
- Giving birth after 32 Weeks of amenorrhea
- Post-partum haemorrhage due to atony
- Inefficiency off the first line treatment
- Written signed consent form
Exclusion Criteria:
- known allergy to prostaglandin
- haemostasis anomalies before labour
- anticoagulant treatment
- fetal death
- accreta or percreta placenta
- under 18 years
- delivery before 32 weeks of amenorrhea
- post-partum bleeding not suspected to be due to atonic uterus
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
MISOPROSTOL
Arm Description
Outcomes
Primary Outcome Measures
quantification of blood loss
quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer
Secondary Outcome Measures
Sulprostone Requirement
distribution of blood loss over time, blood loss higher than 500mL after treatment, blood transfusion, changes in haemoglobin concentration and haematocrit levels, recourse to sulprostone, uterine arteries embolizations and hysterectomy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01116050
Brief Title
Intrarectal Misoprostol in Postpartum Haemorrhage
Acronym
HEMOSTOP
Official Title
Second-line Treatment of Post-partum Haemorrhage With Intrarectal Misoprostol: a Multicentre, Double Blind, Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The most efficient treatment of severe PPH is sulprostone which is associated with cardiac complications. The objective of this study was to assess the efficacy and the safety of intrarectal misoprostol for curative postpartum haemorrhage treatment.
We conducted a multicenter double blind randomized placebo control trial between June 2004 and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin treatment.
Our main criteria of judgement was quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
MISOPROSTOL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
5 tablets of 200 microgram geach intra rectal by opaque introducer
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 tablets in opque introducer
Primary Outcome Measure Information:
Title
quantification of blood loss
Description
quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer
Time Frame
15 minutes after treatment administration
Secondary Outcome Measure Information:
Title
Sulprostone Requirement
Description
distribution of blood loss over time, blood loss higher than 500mL after treatment, blood transfusion, changes in haemoglobin concentration and haematocrit levels, recourse to sulprostone, uterine arteries embolizations and hysterectomy
Time Frame
30 minutes after the diagnostic of post-partum hemorrhage
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 18 yrs old
Giving birth after 32 Weeks of amenorrhea
Post-partum haemorrhage due to atony
Inefficiency off the first line treatment
Written signed consent form
Exclusion Criteria:
known allergy to prostaglandin
haemostasis anomalies before labour
anticoagulant treatment
fetal death
accreta or percreta placenta
under 18 years
delivery before 32 weeks of amenorrhea
post-partum bleeding not suspected to be due to atonic uterus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel DREYFUS, MD, PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33232518
Citation
Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
Results Reference
derived
Learn more about this trial
Intrarectal Misoprostol in Postpartum Haemorrhage
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