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Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

NCT ID: NCT01080846

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Postpartum Hemorrhage

Keywords

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Primary postpartum hemorrhage PPH uterine atony high fever hyperpyrexia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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600 mcg of sublingual misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

600 mcg of sublingual misoprostol

Interventions

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Misoprostol

600 mcg of sublingual misoprostol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Gynuity Health Projects

Principal Investigators

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Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Andrew Weeks, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Liverpool

Wilfrido Leon, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

Gustavo Barrera, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

Jill Durocher

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Hospital Gineco Obstetrico Isidro Ayora

Quito, Pichincha, Ecuador

Site Status

Countries

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Ecuador

References

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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.

Reference Type BACKGROUND
PMID: 20060161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20060162 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22769055 (View on PubMed)

Related Links

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http://www.gynuity.org

Gynuity Health Projects

Other Identifiers

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2.4.6

Identifier Type: -

Identifier Source: org_study_id