Sublingual Misoprostol for Induction of Labor

Phase 4

Completed

• Conditions: Labor; Induced
• Interventions: Drug: Misoprostol 25mcg; Drug: Sublingual Misoprostol

• Registration Number: NCT01406392
• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute

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.

Study Timeline

• Study First Submitted: 2011-07-29
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Study Start: 2014-07-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-15
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Misoprostol 25 mcg	Misoprostol 25mcg	Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Each pacient will receve at the same time a sublingual placebo tablet and vaginal misoprostol or sublingual misoprostol and vaginal placebo tablet. It will depend of the randomization.
Sublingual Misoprostol 12,5mcg	Sublingual Misoprostol	Sublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets.

Primary Outcome Measures

Name	Time	Method
Frequency of taquissistoly	48 hours	during 48 hours the presence of taquissistoly will be observed

Secondary Outcome Measures

Name	Time	Method
Hyperstimulation Syndrome	48 hours	during 48 hours the presence of hyperstimulation syndrome will be observed
the mother's preferred route of administration	after 48 hours	Ask to mother what route of administratios was the best for her
need for oxytocin	after 48 hours	to avaluete the use of oxytocin during the labour
changes in the cervix at 12 and 24 hours	12 and 24 hours	changes in the cervix
duration of labour	after 48 hours	to avaluete the time of duration of labour
failure to achieve vaginal delivery within 12 and 24 hours	12 and 24 hours	failure to achieve vaginal delivery
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.
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
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
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
need for epidural anaesthesia	after 48 hours	to avaluete the need for epidural anaesthesia
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);

Trial Locations

Locations (1)

Instituto de Medicina Integral Professor Fernando Figueira (IMIP); 🇧🇷 Recife, Pernambuco, Brazil