Clinical trial NCT01406392: Sublingual Misoprostol for Induction of Labor
Official title: Sublingual Misoprostol 12,5 mcg Versus Vaginal Misoprostol 25 mcg for Induction of Labour of Alive and Term Fetus : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor
Induced
Keywords: Misoprostol
Sublingual
Induced
Labor
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Maternidade Escola Assis Chateaubriand
First posted: 2011-08-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of taquissistoly
timeFrame: 48 hours
Secondary outcomes:
measure: Hyperstimulation Syndrome
timeFrame: 48 hours
measure: changes in the cervix at 12 and 24 hours
timeFrame: 12 and 24 hours
measure: failure to achieve vaginal delivery within 12 and 24 hours
timeFrame: 12 and 24 hours
measure: the mother's preferred route of administration
timeFrame: after 48 hours
measure: time between the first dose and the onset of labour and delivery
timeFrame: after 48 hours
measure: duration of labour
timeFrame: after 48 hours
measure: need for oxytocin
timeFrame: after 48 hours
measure: failed induction of labour
timeFrame: after 48 hours
measure: Caesarean section and the indications for this procedure
timeFrame: after 48 hours
measure: need for epidural anaesthesia
timeFrame: after 48 hours
measure: maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);
timeFrame: after 48 hours
measure: severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death
timeFrame: 48 hours
measure: meconium in the amniotic fluid
timeFrame: 48 hours
measure: non-reassuring foetal heart rate
timeFrame: 48 hours
measure: one- and five-minute Apgar scores <7
timeFrame: after 48 hours
measure: admission of the newborn to a neonatal intensive care unit
timeFrame: after 48 hours
measure: need for neonatal resuscitation
timeFrame: after 48 hours
measure: severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.
timeFrame: after 48 hours
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira (IMIP)
state: Pernambuco
Study officials:
References:
citation: Gattas DSMB, de Amorim MMR, Feitosa FEL, da Silva-Junior JR, Ribeiro LCG, Souza GFA, Souza ASR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial. Reprod Health. 2020 Apr 10;17(1):47. doi: 10.1186/s12978-020-0901-8.
citation: Gattas DSMB, da Silva Junior JR, Souza ASR, Feitosa FE, de Amorim MMR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial protocol. Reprod Health. 2018 Apr 18;15(1):65. doi: 10.1186/s12978-018-0508-5.