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
  Purpose

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.


Condition Intervention Phase
Postpartum Hemorrhage
Drug: Misoprostol
Drug: Oxytocin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Jawaharlal Nehru Medical College:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 652
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373359

Locations
India
Jawaharlal Nehru Medical College
Belgaum, Karnataka, India, 590010
Sponsors and Collaborators
Jawaharlal Nehru Medical College
Cipla Ltd.
AstraZeneca
Investigators
Principal Investigator: M B Bellad, M.D. Jawaharlal Nehru Medical College
  More Information

No publications provided

Responsible Party: Dr. M. B. Bellad, Professor, Department. of Obstetetrics. & Gynaecology, KLE University Jawaharlal Nehru Medical College
ClinicalTrials.gov Identifier: NCT01373359     History of Changes
Other Study ID Numbers: MDC/DOME/3707
Study First Received: June 9, 2011
Last Updated: June 13, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Jawaharlal Nehru Medical College:
Misoprostol, oxytocin, postpartum blood loss, hemoglobin

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 23, 2014