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Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin

Primary Purpose

Prevention of Post Partum Hemorrhage After Labor Induction

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Misoprostol after delivery
Oxytocin after delivery
Oxytocin before delivery
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Post Partum Hemorrhage After Labor Induction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • delivery by cesarean section
  • received other prophylactic uterotonics

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Misoprostol

Oxytocin

Arm Description

Rectal misoprostol

intravenous oxytocin

Outcomes

Primary Outcome Measures

Hemoglobin level
10% or more drop in hemoglobin

Secondary Outcome Measures

mean hemoglobin drop
difference between pre and post partum hemoglobin levels
mean estimated blood loss
visual estimation of blood loss
drop in hemoglobin
2g/dl drop in hemoglobin
side effect of medication
fever > 38°C, diarrhea, and shivering

Full Information

First Posted
November 30, 2016
Last Updated
January 12, 2018
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02983591
Brief Title
Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin
Official Title
Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

5. Study Description

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.
Detailed Description
Our study will be carried out at Makassed General Hospital, a tertiary-level maternity unit performing about 1000 deliveries annually. After approval by the hospital Ethics and Research Committee, women with single viable pregnancy, in cephalic presentation, at full term and whom labor was induced by Oxytocin will be eligible for inclusion. After informed consents is obtained, the parturients will be assigned randomly according to a computer generated sequence in block lists of 25each time to receive either 1000mcg of Misoprostol rectally or 20 units of Oxytocin intravenously to run at a rate of 150ml/hr. The medications will be given just after cord clamping and before delivery of the placenta. Active management of the third stage of labor will be carried out simultaneously with early cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine massage in addition to the uterotonic according to assignment of the patient. Assessment of the uterine condition will be done by the obstetrician or his assistant, together with visually estimating the amount of blood loss. Once uterine atony or estimated blood loss (EBL) of more than 500 ml is noticed, another uterotonics will be administered according to the condition and at the discretion of the obstetrician. Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH) by the routine uterine massage will urge the use of either different uterotonics or surgical intervention if necessary. Blood transfusion will be ordered for the cases whose visual estimation of blood loss is more than 1000ml or when the patient was hemodynamically unstable. In order to compare the effect of each medication alone on the amount of blood loss, we will then exclude those patients who received blood transfusion or additional uterotonics. A base line hemoglobin and hematocrit levels will be withdrawn on admission and another reading 12 hours postpartum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Post Partum Hemorrhage After Labor Induction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Experimental
Arm Description
Rectal misoprostol
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
intravenous oxytocin
Intervention Type
Drug
Intervention Name(s)
Misoprostol after delivery
Intervention Description
Patients will receive 1000 mcg Misoprostol per rectum
Intervention Type
Drug
Intervention Name(s)
Oxytocin after delivery
Intervention Description
Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
Intervention Type
Drug
Intervention Name(s)
Oxytocin before delivery
Intervention Description
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
Primary Outcome Measure Information:
Title
Hemoglobin level
Description
10% or more drop in hemoglobin
Time Frame
12 to 24 hours post partum
Secondary Outcome Measure Information:
Title
mean hemoglobin drop
Description
difference between pre and post partum hemoglobin levels
Time Frame
12 to 24 hours post partum
Title
mean estimated blood loss
Description
visual estimation of blood loss
Time Frame
during the first hour post partum
Title
drop in hemoglobin
Description
2g/dl drop in hemoglobin
Time Frame
12 to 24 hours post partum
Title
side effect of medication
Description
fever > 38°C, diarrhea, and shivering
Time Frame
upto 48 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with single viable pregnancy, cephalic presentation, at full term whom labor was induced by Oxytocin were eligible Exclusion Criteria: delivery by cesarean section received other prophylactic uterotonics
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

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Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin

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