Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

Study Overview
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Brief Summary
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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.

Official Title
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A One Year Double Blind Randomized Controlled Trial of Sublingual Misoprostol (400 µg) Versus Intramuscular Oxytocin (10 IU) in the Prevention of Postpartum Bloodloss at KLE Hospital, Belgaum

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual misoprostol<br>400 µg powdered misoprostol administered sublingually; IM placebo | Drug: Misoprostol<br>* 400 µg sublingual misoprostol<br>|
| Active Comparator: Oxytocin<br>10 IU IM oxytocin; placebo powder | Drug: Oxytocin<br>* 10 IU IM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 2 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 2 hours after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Misoprostol, oxytocin, postpartum blood loss, hemoglobin