Clinical trial NCT01373359: Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Keywords: Misoprostol, oxytocin, postpartum blood loss, hemoglobin
Lead sponsor: Jawaharlal Nehru Medical College
Sponsor class: OTHER
Collaborators: name: Cipla Ltd.
name: AstraZeneca
First posted: 2011-06-14
Enrollment: 652
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: mean blood loss
timeFrame: 2 hours after delivery
measure: postpartum hemorrhage (Blood loss >500 mls)
timeFrame: 2 hours after delivery
Secondary outcomes:
measure: The percent of women experiencing a ≥10% postpartum decline in haemoglobin
timeFrame: At presentation for delivery and 12-48 hours after delivery
measure: Medication side effects
timeFrame: 2 hours after delivery
Other outcomes:
Locations:
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
state: Karnataka
Study officials:
affiliation: Jawaharlal Nehru Medical College
name: M B Bellad, M.D.
role: PRINCIPAL_INVESTIGATOR
References: