A Phase 3 interventional study of Misoprostol and Oxytocin in Postpartum Hemorrhage, sponsored by Jawaharlal Nehru Medical College. Completed at 1 site in India. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2011-06-14.
Sponsored by Jawaharlal Nehru Medical College · Phase 3, Interventional, and Prevention
Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.
Exclusion Criteria:
400 µg powdered misoprostol administered sublingually; IM placebo
Drug: Misoprostol
10 IU IM oxytocin; placebo powder
Drug: Oxytocin
400 µg sublingual misoprostol
10 IU IM
mean blood loss
Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml).
Time frame: 2 hours after delivery
postpartum hemorrhage (Blood loss >500 mls)
Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml).
Time frame: 2 hours after delivery
The percent of women experiencing a ≥10% postpartum decline in haemoglobin
Hemoglobin was obtained at presentation for delivery and again between 12 and 48 hours after delivery.
Time frame: At presentation for delivery and 12-48 hours after delivery
Medication side effects
Self reported side effects including nausea, vomiting, diarrhoea, abdominal pain, shivering and elevated temperature
Time frame: 2 hours after delivery
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Jawaharlal Nehru Medical College