Induction of Labour Clinical Trial
Official title:
A Randomized Controlled Trial of Oral Misoprostol, Low Dose Vaginal Misoprostol and Vaginal Dinoprostone for Induction of Labour
Labour induction is a frequent obstetric intervention (~20%). Prostaglandins (PGs) are effective agents, but gastrointestinal (GI) intolerance has limited use to non-oral routes. The traditional oxytocin "drip" requires intravenous (IV) use and discourages mobility. Misoprostol, a PG analogue, is marketed for oral treatment of GI disorders, but initiates uterine contraction, an undesirable GI side effect. Recently, there has been a research "boom" on vaginal misoprostol use in pregnancy to induce term labour drawing on this "side effect:". The principal investigator has led one of three groups worldwide which has published on oral misoprostol to study effectiveness, GI tolerance, and safety for mother/baby in term labour induction. Cost per patient has been less then one percent that of other PGs, even less than IV oxytocin.
Labour induction is a frequent obstetric intervention (20-30%). Prostaglandins (PGs) are
effective agents, but gastrointestinal (GI) intolerance has limited use to intracervical and
vaginal administration of PGE2 gels. Misoprostol, a prostaglandin E2 (PGE1) analogue, is
marketed for oral treatment of upper GI disorders. The past five years has seen mushrooming
literature on its use to initiate uterine contractions for pregnancy termination in the first
and second trimesters, and labour induction in the third. Vaginal administration has been
used almost exclusively, has been cost effective (less than one percent the cost of PGE2) and
without demonstrated harm to mother or newborn. The investigators have published a randomized
control trial (RCT) on vaginal use, and have also published a 275 subject RCT of oral
misoprostol versus a traditional induction regime of (physician chosen combinations of
intracervical or vaginal dinoprostone, intravenous (IV) oxytocin and artificial membrane
rupture). Oral misoprostol was effective, well tolerated and without harm to mother or
newborn. The investigators have in press a double blind RCT or oral versus vaginal
misoprostol in 206 subjects. Oral misoprostol was effective, though time to vaginal birth was
226 min longer, due to more time before labour was initiated. Oral misoprostol was associated
with less uterine hyperstimulation (P<0.04). The investigators have also completed an RCT of
oral misoprostol versus IV oxytocin with term pre-labour membrane rupture. Again,
effectiveness was shown. There is no larger published collective experience with oral
misoprostol labour induction. Before embarking on a costly RCT to evaluate more substantive
outcomes (Caesareans or neonatal asphyxia) with sample size greater than 10,000, funding has
been received for this three-group RCT of labour induction at term: oral misoprostol, vaginal
misoprostol, and our centre's established approach.
PRIMARY RESEARCH QUESTION When induction of labour at term is indicated, is there more than a
four-hour difference in time to vaginal birth between vaginal misoprostol (25µg initial dose,
followed by 25-50µg every six hours as needed), oral misoprostol (50µg every four hours as
needed) and the Izaak Walton Killam (IWK) Health Centre established protocol? Secondary
outcomes address harm to the newborn (including cord blood acid base analysis, and defined
birth asphyxia criteria) and mother (Caesareans, peripartum interventions, maternal GI
intolerance and excessive uterine activity).
RESEARCH PLAN Eligible subjects will be at gestations greater than 37 completed weeks, with a
cephalic presenting live single fetus, who have an indication for induction, and no
contraindication to induction, vaginal birth, or PG use. Random allocation will be blocked
and stratified (on membrane status). Sample size calculations were based on: ∆=240 minutes,
α(2 tailed) = 0.05, β=0.05, with a σ=588 minutes from the investigators' prior publications.
Adjustments for anticipated Caesareans (<20%) were made. Sample size is 510. Recruitment
within a year is supported by the group's prior research [more than 1000 inductions per year
at IWK Grace ( the centre's name officially changed in November, 2000, to IWK Health
Centre)].
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