NCT00107874

Brief Summary

Postpartum hemorrhage (PPH) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. With this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of PPH undergoing non-scheduled Cesarean section. We therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 1999

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2005

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

3.1 years

First QC Date

April 11, 2005

Last Update Submit

April 2, 2019

Conditions

Postpartum Hemorrhage

Keywords

Maternalmorbiditymortalitypregnancypostpartum hemorrhageCesarean Section

Outcome Measures

Primary Outcomes (1)

  • Reduction of postpartum hemorrhage

Secondary Outcomes (3)

  • Blood loss

  • medicamentous side effects

  • efficacy of medicaments

Interventions

misoprostolDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-scheduled primary or secondary Cesarean section (CS) after the 37th week of gestation

You may not qualify if:

  • Emergency CS
  • Fetal distress
  • Fetal malformations
  • Preeclampsia and HELLP (Hemolysis-Elevated Liver enzymes-Low Platelet count syndrome)
  • Hypersensitivity to prostaglandins
  • Coagulopathy
  • Severe systemic disorders
  • An American Society of Anesthesiologists (ASA) physical status \>/= 3
  • Severe asthma
  • Prior myomectomy
  • Maternal fever (\> 38.5 °C)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's University Hospital, Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Irène Hösli, Prof. Dr. MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2005

First Posted

April 12, 2005

Study Start

January 1, 1999

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

CH(1)