Clinical trial NCT01080846: Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage
Official title: Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Primary postpartum hemorrhage
PPH
uterine atony
high fever
hyperpyrexia
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: University of Liverpool
First posted: 2010-03-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of fever above 40.0 degrees centigrade
timeFrame: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH
Secondary outcomes:
measure: Side effect profile of misoprostol for PPH treatment
timeFrame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
measure: Acceptability of side effect profile among women
timeFrame: Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Hospital Gineco Obstetrico Isidro Ayora
state: Pichincha
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Liverpool
name: Andrew Weeks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
name: Wilfrido Leon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
name: Gustavo Barrera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon 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.
citation: 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.
citation: Leon W, Durocher J, Barrera G, Pinto E, Winikoff B. Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make? BMC Pregnancy Childbirth. 2012 Jul 7;12:65. doi: 10.1186/1471-2393-12-65.