Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080846
• Other study ID #: 2.4.6
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: November 9, 2010
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.

Description:

The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Able and willing to give informed consent

• Vaginal delivery

• Postpartum hemorrhage due to suspected uterine atony

• Oxytocin given during 3rd stage of labor

Exclusion Criteria:

• Known allergy to prostaglandins or misoprostol

• Underwent cesarean section

• Postpartum hemorrhage NOT due to suspected uterine atony

• Oxytocin NOT given during 3rd stage of labor

• Severe ill health

• Unable to give informed consent

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
600 mcg of sublingual misoprostol

Locations

Country	Name	City	State
Ecuador	Hospital Gineco Obstetrico Isidro Ayora	Quito	Pichincha

Sponsors (3)

Lead Sponsor	Collaborator
Gynuity Health Projects	Bill and Melinda Gates Foundation, University of Liverpool

Country where clinical trial is conducted

Ecuador, 

References & Publications (2)

Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6. — View Citation

Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, León W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of fever above 40.0 degrees centigrade	% of women with body temperature measures =40°C	Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH	Yes
Secondary	Side effect profile of misoprostol for PPH treatment	% of women experiencing any shivering and any fever or any other side effect	Side effects observed for 3 hours post-treatment with misoprostol for PPH	Yes
Secondary	Acceptability of side effect profile among women	% of women who rate side effects as acceptable, neutral, unacceptable, don't know	Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)	No

External Links

•   Gynuity Health Projects