NCT03463070

Brief Summary

comparison of the effect of misoprostol before and after cesarean on the blood loss

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

March 4, 2018

Last Update Submit

March 12, 2018

Conditions

Post Partum Hemorrhage

Keywords

misoprostolpostpartum haemorrhage

Outcome Measures

Primary Outcomes (2)

  • intraoperative blood loss

    Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)

    the operation time

  • postoperative blood loss

    weighing the soaked napkins after collection of soaked towel

    every 6 hours during first 24 hours.

Study Arms (2)

preoperative misoprostol group

ACTIVE COMPARATOR

70 women who received 600 mg misoprostol rectally preoperatively before cesarean section

Drug: rectal misoprostol 600mg

postoperative misoprostol group

ACTIVE COMPARATOR

70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section

Drug: rectal misoprostol 600mg

Interventions

rectal misoprostol 600mgDRUG

70 women who received 600 mg misoprostol postoperatively at operating theatre

postoperative misoprostol grouppreoperative misoprostol group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women not in active labor have reactive non-stress test.
  • No contraindications to prostaglandins.
  • Have no history of coagulopathy.

You may not qualify if:

  • Placenta previa.
  • Maternal hypertension.
  • Diabetes mellitus.
  • Previous CS and those with active labor.
  • Multiple Fibroid uterus.
  • Multiple pregnancies or polyhydramnios.
  • Previous myomectomy, previous history of PPH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

March 4, 2018

First Posted

March 13, 2018

Study Start

March 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)