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

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ClinicalTrials.gov Identifier: NCT02983591
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Manal Hubeish, Makassed General Hospital

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.

Condition or disease Intervention/treatment Phase
Prevention of Post Partum Hemorrhage After Labor Induction Drug: Misoprostol after delivery Drug: Oxytocin after delivery Drug: Oxytocin before delivery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial
Study Start Date : November 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Misoprostol
Rectal misoprostol
Drug: Misoprostol after delivery
Patients will receive 1000 mcg Misoprostol per rectum

Drug: Oxytocin before delivery
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

Experimental: Oxytocin
intravenous oxytocin
Drug: Oxytocin after delivery
Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h

Drug: Oxytocin before delivery
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 Measures :
  1. Hemoglobin level [ Time Frame: 12 to 24 hours post partum ]
    10% or more drop in hemoglobin


Secondary Outcome Measures :
  1. mean hemoglobin drop [ Time Frame: 12 to 24 hours post partum ]
    difference between pre and post partum hemoglobin levels

  2. mean estimated blood loss [ Time Frame: during the first hour post partum ]
    visual estimation of blood loss

  3. drop in hemoglobin [ Time Frame: 12 to 24 hours post partum ]
    2g/dl drop in hemoglobin

  4. side effect of medication [ Time Frame: upto 48 hours after delivery ]
    fever > 38°C, diarrhea, and shivering



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983591


Locations
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Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital

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Responsible Party: Manal Hubeish, OBGYN attending physician, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT02983591     History of Changes
Other Study ID Numbers: 16082016
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents