Sublingual Misoprostol in Reduction of Caesarean Blood Loss (SUMIROCBLOL)
Post Partum Hemorrhage
About this trial
This is an interventional prevention trial for Post Partum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Pregnant women at term (37+0 weeks to 41+6 weeks gestational age) for elective or non-elective caesarean sections
- Pregnant women who have risk factor for primary postpartum haemorrhage
- Pregnant women who consent to participate in the study
Exclusion Criteria:
- Pregnant women who withhold consent to participate in the study
- Caesarean sections for dire emergencies (umbilical cord prolapse, suspected fetal distress and active antepartum haemorrhage)
- Previous caesarean sections or other uterine surgeries
- Pregnant women with no risk factor for primary postpartum haemorrhage
- Allergy to misoprostol use
- Known history of hepatic, renal and haematological disorders
- Caesarean section to be done under general anaesthesia
- Fever (temperature ≥ 37.5 degrees centigrade)
- Pre-operative anaemia (pre-operative haematocrit level < 30 %)
- Pregnant women who are unconscious or have eclampsia
Sites / Locations
- Federal Medical Centre YenagoaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Misoprostol
Placebo
400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets at the point of starting the uterine incision at caesarean section, then bolus administration of 10 IU of intravenous oxytocin followed by an infusion of 20 IU of oxytocin in 500 ml of normal saline at a rate of twenty drops per minute to run over eight hours.
Two sublingual placebo tablets similar to the misoprostol tablets at the point of starting the uterine incision at caesarean section, then bolus administration of 10 IU of intravenous oxytocin followed by an infusion of 20 IU of oxytocin in 500 ml of normal saline at a rate of twenty drops per minute to run over eight hours.