Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin
NCT ID: NCT02983591
Last Updated: 2018-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2016-11-30
2017-12-30
Brief Summary
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Detailed Description
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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 A base line hemoglobin and hematocrit levels will be withdrawn on admission and another reading 12 hours postpartum.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Misoprostol
Rectal misoprostol
Misoprostol after delivery
Patients will receive 1000 mcg Misoprostol per rectum
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
Oxytocin
intravenous oxytocin
Oxytocin after delivery
Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
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
Interventions
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Misoprostol after delivery
Patients will receive 1000 mcg Misoprostol per rectum
Oxytocin after delivery
Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
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
Eligibility Criteria
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Inclusion Criteria
* cephalic presentation,
* at full term
* whom labor was induced by Oxytocin were eligible
Exclusion Criteria
* received other prophylactic uterotonics
18 Years
45 Years
FEMALE
No
Sponsors
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Makassed General Hospital
OTHER
Responsible Party
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Manal Hubeish
OBGYN attending physician
Locations
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Makassed General Hospital
Beirut, , Lebanon
Countries
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Other Identifiers
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16082016
Identifier Type: -
Identifier Source: org_study_id
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