Oral Titrated Misoprostol for Induction of Labour

Labor, Induced Clinical Trial

— OTISMISO  

Official title:

Oral Misoprostol Titrated Solution Versus Vaginal Misoprostol for Induction of Labour: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992524
• Other study ID #: ORALTIMI
• Status: Completed
• Phase: N/A
• First received: October 8, 2009
• Last updated: June 22, 2011
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2009
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive 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, sublingual and, more recently, oral titrated solution. The purpose of this study is to compare effectiveness and safety of this oral misoprostol titrated solution with vaginal misoprostol administration for induction of labour with an alive fetus. A randomized controlled double-blind trial will be carried in three hospitals: Instituto de Medicina Integral Prof. Fernando Figueira, Universidade Federal do Ceará and Instituto de Saúde Elpídio de Almeida, from November 2009 to November 2011. A total of 400 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) age less than 18 years; b) previous uterine scar; c) nonvertex presentation; d) non-reassuring fetal status; e) fetal anomalies; f) fetal growth restriction; g) genital bleeding; h) tumors, malformations and/or ulcers of vulva, perineum or vagina. They will be randomized to receive an oral misoprostol titrated solution with vaginal placebo tablet or oral placebo solution with vaginal misoprostol tablet. Oral solution will have misoprostol at a concentration of 2mcg/ml or placebo. Vaginal tablets will have 25mcg of misoprostol or placebo. Oral solution dose will be 20mcg/hour (misoprostol) or 10ml/hour (placebo) in the first six hours with an increase of 20mcg/hour (10ml/hour) of misoprostol or placebo each six hours if labour does not start, until the maximum dose of 80mcg/hour or 40ml/hour in the first 24 hours. This maximum dose can be maintained for more 24 hours if needed. Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Primary outcomes will be vaginal delivery within 24 hours, hyperstimulation syndrome, cesarean section, severe neonatal morbidity or perinatal death, serious maternal morbidity or maternal death. Secondary outcomes will be 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, tachysystole, 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: 400
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Indication for labour induction

• Term pregnancy with alive fetus

• Bishop score less than six

Exclusion Criteria:

• Age less than 18 years

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor, Induced

Intervention

Drug:
• Misoprostol
Oral solution dose will be 20mcg/hour (misoprostol) or 10ml/hour (placebo) in the first six hours with an increase of 20mcg/hour (10ml/hour) of misoprostol or placebo each six hours if labour does not start, until the maximum dose of 80mcg/hour or 40ml/hour in the first 24 hours.
• Misoprostol
Vaginal tablets will have 25mcg of misoprostol or placebo.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira	Instituto de Saúde Elpidio de Almeida, Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal delivery		24 hours	No
Primary	Hyperstimulation syndrome		24 hours	Yes
Primary	Cesarean section		3 days	No
Primary	Severe neonatal morbidity or perinatal death		28 days	Yes
Primary	Serious maternal morbidity or maternal death		42	Yes
Secondary	Need of oxytocin for augmentation of labour		48 hours	No
Secondary	Number of doses needed to bring on labour		48 hours	No
Secondary	Interval from 1st dose to labour		48 hours	No
Secondary	Interval from 1st dose to delivery		48 hours	No
Secondary	Failed induction		72 hours	No
Secondary	Tachysystole		48 hours	Yes
Secondary	Uterine rupture		72 houras	Yes
Secondary	Need of labour analgesia		48 hours	No
Secondary	Instrumental delivery		48 hours	No
Secondary	Side effects: nausea, vomit, diarrhea, postpartum haemorrhage		72 hours	Yes
Secondary	Maternal death		42 days	Yes
Secondary	Meconium		72 hours	Yes
Secondary	Non-reassuring fetal heart rate		72 hours	Yes
Secondary	Apgar scores less than 7 at 1st and 5th minute		1st and 5th minutes after delivery	Yes
Secondary	Admission at neonatal intensive care unit		28 days	Yes
Secondary	Perinatal or neonatal death		28 days	Yes
Secondary	Neonatal encephalopathy		28 days	Yes
Secondary	Women not satisfied with route of drug administration		48 hours after delivery	Yes