Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

NCT01373359 | Completed Phase 3

• 1 other identifier: MDC/DOME/3707
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

Misoprostol, oxytocin, postpartum blood loss, hemoglobin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The percent of women experiencing a ≥10% postpartum decline in haemoglobin

  At presentation for delivery and 12-48 hours after delivery

• Medication side effects

  2 hours after delivery

Study Arms (2)

Sublingual misoprostol

EXPERIMENTAL

400 µg powdered misoprostol administered sublingually; IM placebo

Drug: Misoprostol

Oxytocin

ACTIVE COMPARATOR

10 IU IM oxytocin; placebo powder

Drug: Oxytocin

Interventions

Misoprostol DRUG

400 µg sublingual misoprostol

Sublingual misoprostol

Oxytocin DRUG

10 IU IM

Oxytocin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jawaharlal Nehru Medical College: lead
• Cipla Ltd.: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590010, India

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• M B Bellad, M.D.

  Jawaharlal Nehru Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 14, 2011
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 14, 2011

Record last verified: 2008-01

Locations

IN (1)