Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Misoprostol; Drug: Oxytocin

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Belgaum, Karnataka, India, 590010
      • Jawaharlal Nehru Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jawaharlal Nehru Medical College
• Collaborators: AstraZeneca; Cipla Ltd.
• Investigators: Principal Investigator: M B Bellad, M.D., Jawaharlal Nehru Medical College

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Keywords: Misoprostol, oxytocin, postpartum blood loss, hemoglobin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: MDC/DOME/3707