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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01116050
Other study ID # 03-104
Secondary ID 03-104
Status Completed
Phase Phase 3
First received May 3, 2010
Last updated May 19, 2011
Start date January 2004

Study information

Verified date May 2011
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol
5 tablets of 200 microgram geach intra rectal by opaque introducer
Placebo
5 tablets in opque introducer

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Outcome

Type Measure Description Time frame Safety issue
Primary 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 15 minutes after treatment administration No
Secondary 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 30 minutes after the diagnostic of post-partum hemorrhage No
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