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Completed

NCT Number: NCT01373359

Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590010, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Misoprostol

Drug

400 µg sublingual misoprostol

Oxytocin

Drug

10 IU IM

Primary outcomes

  1. mean blood loss

    Time frame: 2 hours after delivery

    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. postpartum hemorrhage (Blood loss >500 mls)

    Time frame: 2 hours after delivery

    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 outcomes

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

    Time frame: At presentation for delivery and 12-48 hours after delivery

    Hemoglobin was obtained at presentation for delivery and again between 12 and 48 hours after delivery.

  2. Medication side effects

    Time frame: 2 hours after delivery

    Self reported side effects including nausea, vomiting, diarrhoea, abdominal pain, shivering and elevated temperature

Sponsors and collaborators

Lead sponsor

Jawaharlal Nehru Medical College

Other

Collaborators

  • AstraZeneca
  • Cipla Ltd.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 14, 2011
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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