Oral Titrated Misoprostol for Induction of Labour

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00992524
• Date of registration: 08/10/2009
• Primary sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Public title: Oral Titrated Misoprostol for Induction of Labour OTISMISO
• Scientific title: Oral Misoprostol Titrated Solution Versus Vaginal Misoprostol for Induction of Labour: Randomized Controlled Trial
• Date of first enrolment: November 2009
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00992524
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Brazil

Contacts

• Name: Alex SR Souza, Phd student
• Affiliation: Instituto de Medicina Integral Professor Fernando Figueira - IMIP

• Name: Aurélio AR Costa, PhD
• Affiliation: Instituto de Medicina Integral Professor Fernando Figueira - IMIP

• Name: Melania MR Amorim, Phd
• Affiliation: Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Labor, Induced

Intervention(s)

Drug: Misoprostol

Primary Outcome(s)

Cesarean section [Time Frame: 3 days]

Hyperstimulation syndrome [Time Frame: 24 hours]

Serious maternal morbidity or maternal death [Time Frame: 42]

Severe neonatal morbidity or perinatal death [Time Frame: 28 days]

Vaginal delivery [Time Frame: 24 hours]

Secondary Outcome(s)

Admission at neonatal intensive care unit [Time Frame: 28 days]

Apgar scores less than 7 at 1st and 5th minute [Time Frame: 1st and 5th minutes after delivery]

Failed induction [Time Frame: 72 hours]

Instrumental delivery [Time Frame: 48 hours]

Interval from 1st dose to delivery [Time Frame: 48 hours]

Interval from 1st dose to labour [Time Frame: 48 hours]

Maternal death [Time Frame: 42 days]

Meconium [Time Frame: 72 hours]

Need of labour analgesia [Time Frame: 48 hours]

Need of oxytocin for augmentation of labour [Time Frame: 48 hours]

Neonatal encephalopathy [Time Frame: 28 days]

Non-reassuring fetal heart rate [Time Frame: 72 hours]

Number of doses needed to bring on labour [Time Frame: 48 hours]

Perinatal or neonatal death [Time Frame: 28 days]

Side effects: nausea, vomit, diarrhea, postpartum haemorrhage [Time Frame: 72 hours]

Tachysystole [Time Frame: 48 hours]

Uterine rupture [Time Frame: 72 houras]

Women not satisfied with route of drug administration [Time Frame: 48 hours after delivery]

Secondary ID(s)

ORALTIMI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Saúde Elpidio de Almeida

Universidade Federal do Ceara