NCT03148574

Brief Summary

Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

May 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

May 9, 2017

Last Update Submit

April 22, 2021

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • amount of intraoperative blood loss

    30 minutes

Study Arms (2)

misoprostol

EXPERIMENTAL

intrauterine 400 microgram

Drug: Misoprostol

oxytocin

ACTIVE COMPARATOR

intravenous infusion 10 units

Drug: Oxytocin

Interventions

MisoprostolDRUG

intrauterine tablets

misoprostol
OxytocinDRUG

intravenous

oxytocin

Eligibility Criteria

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

You may qualify if:

  • Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.
  • Had no history of coagulopathy. 4-Accepting to participate in the study.

You may not qualify if:

  • \\1-women with anemia (Haemoglobin \<8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

MisoprostolOxytocin

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 FactorsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 11, 2017

Study Start

July 2, 2017

Primary Completion

September 15, 2019

Study Completion

December 15, 2019

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)