NCT02983591

Brief Summary

The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use in the third stage of labor ineffective in reducing post partum blood loss as compared to other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in reducing post partum hemorrhage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

November 30, 2016

Last Update Submit

January 12, 2018

Conditions

Prevention of Post Partum Hemorrhage After Labor Induction

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level

    10% or more drop in hemoglobin

    12 to 24 hours post partum

Secondary Outcomes (4)

  • mean hemoglobin drop

    12 to 24 hours post partum

  • mean estimated blood loss

    during the first hour post partum

  • drop in hemoglobin

    12 to 24 hours post partum

  • side effect of medication

    upto 48 hours after delivery

Study Arms (2)

Misoprostol

EXPERIMENTAL

Rectal misoprostol

Drug: Misoprostol after deliveryDrug: Oxytocin before delivery

Oxytocin

EXPERIMENTAL

intravenous oxytocin

Drug: Oxytocin after deliveryDrug: Oxytocin before delivery

Interventions

Misoprostol after deliveryDRUG

Patients will receive 1000 mcg Misoprostol per rectum

Misoprostol
Oxytocin after deliveryDRUG

Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h

Oxytocin
Oxytocin before deliveryDRUG

All patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor

MisoprostolOxytocin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with single viable pregnancy,
  • cephalic presentation,
  • at full term
  • whom labor was induced by Oxytocin were eligible

You may not qualify if:

  • delivery by cesarean section
  • received other prophylactic uterotonics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OBGYN attending physician

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 6, 2016

Study Start

November 1, 2016

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

LE(1)