NCT03366259

Brief Summary

The aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of 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
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2

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

December 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

December 4, 2017

Last Update Submit

December 7, 2017

Conditions

Intrapartum Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • amount of intraoperative blood loss

    number of soaked towels

    during cesarean section

  • postpartum hemorrhage

    blood loss after cesarean section

    24 hour after cesarean section

Secondary Outcomes (1)

  • fetal condition

    5 minutes after cesarean section

Study Arms (2)

Group A (Misoprostol group)

ACTIVE COMPARATOR

200 mcg rectal Misoprostol administration before cesarean section

Drug: Misoprostol 200Mcg TabProcedure: elective cesarean section

Group B (control group)

PLACEBO COMPARATOR

No prostaglandins administration before cesarean section

Procedure: elective cesarean section

Interventions

Misoprostol 200Mcg TabDRUG

administration of 200 Mcg of misoprotol rectal

Group A (Misoprostol group)
elective cesarean sectionPROCEDURE

elective cesarean section for full term patients

Group A (Misoprostol group)Group B (control group)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • medical disorder with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

December 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

December 11, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)