Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373359
• Other study ID #: MDC/DOME/3707
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2011
• Last updated: June 13, 2011
• Start date: March 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Jawaharlal Nehru Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College	Belgaum	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Jawaharlal Nehru Medical College	AstraZeneca, Cipla Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Medication side effects	Self reported side effects including nausea, vomiting, diarrhoea, abdominal pain, shivering and elevated temperature	2 hours after delivery	Yes