NCT03591913

Brief Summary

Cesarean section is one of the most common major surgical operations among women. In 2015, the incidence of cesarean section in Woman Health Hospital in Assiut University accounts for 51.3 % of all deliveries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_4

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, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

July 8, 2018

Last Update Submit

September 17, 2018

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • mean intraoperative blood loss

    Blood loss estimation will commence immediately following the skin incision

    24 hours

Study Arms (2)

study group

EXPERIMENTAL

will receive sublingual misoprostol immediately after urinary catheterization and before skin incision

Drug: Misoprostol

control group

ACTIVE COMPARATOR

will receive sublingual misoprostol immediately after skin closure

Drug: Misoprostol

Interventions

MisoprostolDRUG

Oral tablets

control groupstudy group

Eligibility Criteria

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

You may qualify if:

  • All pregnant women who will undergo elective lower segment cesarean section
  • term ( ≥ 37 weeks)
  • normal fetal heart tracing.

You may not qualify if:

  • Placenta previa-Rupture uterus
  • Classical cesarean section
  • Preterm delivery
  • Hypertensive disorders of pregnancy
  • Bleeding tendency
  • Previous history of postpartum hemorrhage
  • Concurrent anticoagulant therapy
  • Concurrent long-term use of steroids
  • Fetal distress
  • Antepartum haemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

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 Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 19, 2018

Study Start

February 1, 2018

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

EG(1)