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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02163616
Date of registration:	06/06/2014
Prospective Registration:	Yes
Primary sponsor:	Gynuity Health Projects
Public title:	Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
Scientific title:	Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
Date of first enrolment:	September 2015
Target sample size:	635
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02163616
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Argentina	Colombia	Ecuador

Contacts

Name:	Jill Durocher
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Name:	Guillermo Carroli, MD
Address:
Telephone:
Email:
Affiliation:	Centro Rosarino de Estudios Perinatales

Name:	Beverly Winikoff, MD, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Name:	Ilana Dzuba, MPH
Address:
Telephone:
Email:
Affiliation:	Gynuity Health Projects

Key inclusion & exclusion criteria

Inclusion Criteria:

- Able and willing to give informed consent

- Vaginal delivery

- Postpartum hemorrhage due to suspected uterine atony

- Able and willing to give informed consent

Exclusion Criteria:

- Known allergy to misoprostol or other prostaglandins

- Underwent a c-section during the current delivery

- Unable to provide informed consent due to mental impairment, distress during labor or
other reason

- Unwilling and/or unable to respond to brief questionnaires or have her blood drawn

Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Postpartum Hemorrhage

Intervention(s)

Drug: Misoprostol

Primary Outcome(s)

Rates of high fever (=40.0°C) [Time Frame: First 2 hours postpartum]

Secondary Outcome(s)

Acceptability of regimen and side effects to women [Time Frame: Interviewed prior to hospital discharge (about 24 hours postpartum)]

Shock index values [Time Frame: First hour of the puerperium]

Side effect profile of misoprostol for PPH treatment [Time Frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH]

Genetic factors responsible for elevated body temperature [Time Frame: sample taken 24-48 hours postpartum]

Secondary ID(s)

3003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Liverpool

Centro Rosarino de Estudios Perinatales

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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