Sublingual Misoprostol for Induction of Labor

Labor Clinical Trial

— SUBMISO  

Official title:

Sublingual Misoprostol 12,5 mcg Versus Vaginal Misoprostol 25 mcg for Induction of Labour of Alive and Term Fetus : Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406392
• Other study ID #: SUBMISO
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2014
• Est. completion date: November 30, 2016

Study information

• Verified date: September 2019
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induced
• Labor

Intervention

Drug:
• Misoprostol 25mcg
Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.
• Sublingual Misoprostol
Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira (IMIP)	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute	Maternidade Escola Assis Chateaubriand

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of taquissistoly	during 48 hours the presence of taquissistoly will be observed	48 hours
Secondary	Hyperstimulation Syndrome	during 48 hours the presence of hyperstimulation syndrome will be observed	48 hours
Secondary	changes in the cervix at 12 and 24 hours	changes in the cervix	12 and 24 hours
Secondary	failure to achieve vaginal delivery within 12 and 24 hours	failure to achieve vaginal delivery	12 and 24 hours
Secondary	the mother's preferred route of administration	Ask to mother what route of administratios was the best for her	after 48 hours
Secondary	time between the first dose and the onset of labour and delivery	to avaluete the time between the first dose and the onset of labour and delivery	after 48 hours
Secondary	duration of labour	to avaluete the time of duration of labour	after 48 hours
Secondary	need for oxytocin	to avaluete the use of oxytocin during the labour	after 48 hours
Secondary	failed induction of labour	to avaluete the faliled induction of labor	after 48 hours
Secondary	Caesarean section and the indications for this procedure	to avaluete the number of Caesarean section and the indications for this procedure	after 48 hours
Secondary	need for epidural anaesthesia	to avaluete the need for epidural anaesthesia	after 48 hours
Secondary	maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);	to avaluete if occurred any case of maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);	after 48 hours
Secondary	severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death	to avaluete severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death	48 hours
Secondary	meconium in the amniotic fluid	to avaluete meconium in the amniotic fluid	48 hours
Secondary	non-reassuring foetal heart rate	non-reassuring foetal heart rate	48 hours
Secondary	one- and five-minute Apgar scores <7	to avaluete one- and five-minute Apgar scores <7	after 48 hours
Secondary	admission of the newborn to a neonatal intensive care unit	to avaluete admission of the newborn to a neonatal intensive care unit	after 48 hours
Secondary	need for neonatal resuscitation	to avaluete the need for neonatal resuscitation	after 48 hours
Secondary	severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.	to avaluete severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.	after 48 hours