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Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage

Primary Purpose

Postpartum Hemorrhage

Status

Completed

Phase

Not Applicable

Locations

Ecuador

Study Type

Interventional

Intervention

Misoprostol

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hospital Gineco Obstetrico Isidro Ayora

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

600 mcg of sublingual misoprostol

Arm Description

Outcomes

Primary Outcome Measures

Rate of fever above 40.0 degrees centigrade

% of women with body temperature measures ≥40°C

Secondary Outcome Measures

Side effect profile of misoprostol for PPH treatment

% of women experiencing any shivering and any fever or any other side effect

Acceptability of side effect profile among women

% of women who rate side effects as acceptable, neutral, unacceptable, don't know

Full Information

NCT ID

NCT01080846

First Posted

March 2, 2010

Last Updated

November 9, 2010

Sponsor

Gynuity Health Projects

Collaborators

Bill and Melinda Gates Foundation, University of Liverpool

1. Study Identification

Unique Protocol Identification Number

NCT01080846

Brief Title

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

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Gynuity Health Projects

Collaborators

Bill and Melinda Gates Foundation, University of Liverpool

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Hemorrhage

Keywords

Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

600 mcg of sublingual misoprostol

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Intervention Description

600 mcg of sublingual misoprostol

Primary Outcome Measure Information:

Title

Rate of fever above 40.0 degrees centigrade

Description

% of women with body temperature measures ≥40°C

Time Frame

Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH

Secondary Outcome Measure Information:

Title

Side effect profile of misoprostol for PPH treatment

Description

% of women experiencing any shivering and any fever or any other side effect

Time Frame

Side effects observed for 3 hours post-treatment with misoprostol for PPH

Title

Acceptability of side effect profile among women

Description

% of women who rate side effects as acceptable, neutral, unacceptable, don't know

Time Frame

Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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

Overall Study Officials: