Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

• mean blood loss [ Time Frame: 2 hours after delivery ] [ Designated as safety issue: No ]
  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).
• postpartum hemorrhage (Blood loss >500 mls) [ Time Frame: 2 hours after delivery ] [ Designated as safety issue: No ]
  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).

• The percent of women experiencing a ≥10% postpartum decline in haemoglobin [ Time Frame: At presentation for delivery and 12-48 hours after delivery ] [ Designated as safety issue: No ]
  Hemoglobin was obtained at presentation for delivery and again between 12 and 48 hours after delivery.
• Medication side effects [ Time Frame: 2 hours after delivery ] [ Designated as safety issue: Yes ]
  Self reported side effects including nausea, vomiting, diarrhoea, abdominal pain, shivering and elevated temperature

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.

• Drug: Misoprostol
  400 µg sublingual misoprostol
• Drug: Oxytocin
  10 IU IM

• Experimental: Sublingual misoprostol
  400 µg powdered misoprostol administered sublingually; IM placebo
  Intervention: Drug: Misoprostol
• Active Comparator: Oxytocin
  10 IU IM oxytocin; placebo powder
  Intervention: Drug: Oxytocin

Inclusion Criteria:

• Women with a gestational age >28weeks
• singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)
• a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum

Exclusion Criteria:

• Women with pregnancy induced hypertension
• antepartum haemorrhage
• previous caesarean section or presence of uterine scar
• diagnosed chorioamnionitis
• oxytocin induction or augmentation of labour
• intrauterine death
• diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as >4 cm dilatation)

• Cipla Ltd.
• AstraZeneca