Labor, Induced
Conditions
Keywords
Misoprostol, Sublingual, Induced, Labor
Brief 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.
Interventions
DRUGMisoprostol 25mcg
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
Sponsors
Maternidade Escola Assis Chateaubriand
Professor Fernando Figueira Integral Medicine Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Indication for labour induction * Term pregnancy with alive fetus * Bishop score less than six
Exclusion criteria
* Previous uterine scar * Nonvertex presentation * Non-reassuring fetal status * Fetal anomalies * Fetal growth restriction * Genital bleeding * Tumors, malformations and/or ulcers of vulva, perineum or vagina
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of taquissistoly | 48 hours | during 48 hours the presence of taquissistoly will be observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| failure to achieve vaginal delivery within 12 and 24 hours | 12 and 24 hours | failure to achieve vaginal delivery |
| Hyperstimulation Syndrome | 48 hours | during 48 hours the presence of hyperstimulation syndrome will be observed |
| changes in the cervix at 12 and 24 hours | 12 and 24 hours | changes in the cervix |
| time between the first dose and the onset of labour and delivery | after 48 hours | to avaluete the time between the first dose and the onset of labour and delivery |
| duration of labour | after 48 hours | to avaluete the time of duration of labour |
| need for oxytocin | after 48 hours | to avaluete the use of oxytocin during the labour |
| failed induction of labour | after 48 hours | to avaluete the faliled induction of labor |
| Caesarean section and the indications for this procedure | after 48 hours | to avaluete the number of Caesarean section and the indications for this procedure |
| the mother's preferred route of administration | after 48 hours | Ask to mother what route of administratios was the best for her |
| maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever); | after 48 hours | to avaluete if occurred any case of maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever); |
| severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death | 48 hours | to avaluete severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death |
| meconium in the amniotic fluid | 48 hours | to avaluete meconium in the amniotic fluid |
| non-reassuring foetal heart rate | 48 hours | non-reassuring foetal heart rate |
| one- and five-minute Apgar scores <7 | after 48 hours | to avaluete one- and five-minute Apgar scores \<7 |
| admission of the newborn to a neonatal intensive care unit | after 48 hours | to avaluete admission of the newborn to a neonatal intensive care unit |
| need for neonatal resuscitation | after 48 hours | to avaluete the need for neonatal resuscitation |
| severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death. | after 48 hours | to avaluete severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death. |
| need for epidural anaesthesia | after 48 hours | to avaluete the need for epidural anaesthesia |
Countries
Brazil
Outcome results
None listed