Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

This study has been completed.
Sponsor:
Collaborators:
Cipla Ltd.
AstraZeneca
Information provided by:
Jawaharlal Nehru Medical College
ClinicalTrials.gov Identifier:
NCT01373359
First received: June 9, 2011
Last updated: June 13, 2011
Last verified: January 2008

June 9, 2011
June 13, 2011
March 2007
January 2008   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01373359 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Postpartum Hemorrhage
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
652
January 2008
January 2008   (final data collection date for primary outcome measure)

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)
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01373359
MDC/DOME/3707
No
Dr. M. B. Bellad, Professor, Department. of Obstetetrics. & Gynaecology, KLE University Jawaharlal Nehru Medical College
Jawaharlal Nehru Medical College
  • Cipla Ltd.
  • AstraZeneca
Principal Investigator: M B Bellad, M.D. Jawaharlal Nehru Medical College
Jawaharlal Nehru Medical College
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP