NCT01080846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

March 2, 2010

Last Update Submit

November 9, 2010

Conditions

Postpartum Hemorrhage

Keywords

Primary postpartum hemorrhagePPHuterine atonyhigh feverhyperpyrexia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Side effect profile of misoprostol for PPH treatment

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

  • Acceptability of side effect profile among women

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

Study Arms (1)

600 mcg of sublingual misoprostol

EXPERIMENTAL
Drug: Misoprostol

Interventions

MisoprostolDRUG

600 mcg of sublingual misoprostol

600 mcg of sublingual misoprostol

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to give informed consent
  • Vaginal delivery
  • Postpartum hemorrhage due to suspected uterine atony
  • Oxytocin given during 3rd stage of labor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Gineco Obstetrico Isidro Ayora

Quito, Pichincha, Ecuador

Location

Related Publications (3)

  • 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.

    PMID: 20060161BACKGROUND

  • 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.

    PMID: 20060162BACKGROUND

  • 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.

    PMID: 22769055DERIVED

Related Links

MeSH Terms

Conditions

Postpartum HemorrhageUterine InertiaHyperthermia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDystociaBody Temperature ChangesSigns and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Andrew Weeks, MD

    The University of Liverpool

    PRINCIPAL INVESTIGATOR

  • Wilfrido Leon, MD

    HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

    PRINCIPAL INVESTIGATOR

  • Gustavo Barrera, MD

    HOSPITAL GINECO OBSTETRICO ISIDRO AYORA

    PRINCIPAL INVESTIGATOR

  • Jill Durocher

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 4, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations

EC(1)