Sublingual Misoprostol for Induction of Labor
Condition: Labor; Induced
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol
      12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term
      fetus.
    

Detailed description: 
      Several methods for induction of labour are available. However, the most effective and with
      less frequency of adverse effects is still unknown. Vaginal misoprostol has been used
      frequently to induce labour but other routes of administrations have been proposed, such as
      oral and sublingual. The purpose of this study is to compare effectiveness and safety of
      sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg administration for induction
      of labour with an alive and term fetus. A randomized controlled double-blind trial will be
      carried in two hospitals: Instituto de Medicina Integral Prof. Fernando Figueira and
      Universidade Federal do Ceará and Instituto de Saúde Elpídio de Almeida, from July 2014 to
      November 2016. A total of 150 patients must be enrolled. Inclusion criteria are: a)
      indication for labour induction; b) term pregnancy with alive fetus; Bishop score less than
      six. Exclusion criteria are: a) previous uterine scar; b) nonvertex presentation; c)
      non-reassuring fetal status; d) fetal anomalies; e) fetal growth restriction; f) genital
      bleeding; g) tumors, malformations and/or ulcers of vulva, perineum or vagina. They will be
      randomized to receive a sublingual misoprostol 12,5 mcg with vaginal placebo tablet or
      sublingual placebo with vaginal misoprostol 25 mcg tablet. Vaginal tablets will have 25mcg of
      misoprostol or placebo. Sublingual tablet will have 12,5mcg or placebo. Vaginal misoprostol
      or placebo tablets will be administered for each six hours until the maximum dose of 200mcg
      or eight tablets. Primary outcome will be the frequency of tachysystole. Secondary outcomes
      will be vaginal delivery within 24 hours, hyperstimulation syndrome, cesarean section, severe
      neonatal morbidity or perinatal death, serious maternal morbidity or maternal death, need of
      oxytocin for augmentation of labour, number of misoprostol doses needed to bring on labour,
      interval from first dose to labour and first dose to delivery, failed induction, uterine
      rupture, need of labour analgesia, instrumental delivery, side effects, maternal death,
      meconium, non-reassuring fetal heart rate, Apgar scores less than seven at 1st and 5th
      minutes, admission at neonatal intensive care unit, neonatal encephalopaty, perinatal death
      and women not satisfied.
    

Intervention name(s): Misoprostol 25mcg; Sublingual Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.; Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets
Other intervention name(s): Prostokos Cytotec; Prostokos; Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Misoprostol; Sublingual; Induced; Labor