Oral Titrated Misoprostol for Induction of Labour (OTISMISO)

This study has been completed.
Sponsor:
Collaborators:
Instituto de Saúde Elpidio de Almeida
Universidade Federal do Ceara
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00992524
First received: October 8, 2009
Last updated: June 22, 2011
Last verified: October 2009
  Purpose

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.


Condition Intervention
Labor, Induced
Drug: Misoprostol

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

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Vaginal delivery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Hyperstimulation syndrome [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Cesarean section [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Severe neonatal morbidity or perinatal death [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Serious maternal morbidity or maternal death [ Time Frame: 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need of oxytocin for augmentation of labour [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of doses needed to bring on labour [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Interval from 1st dose to labour [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Interval from 1st dose to delivery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Failed induction [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Tachysystole [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Uterine rupture [ Time Frame: 72 houras ] [ Designated as safety issue: Yes ]
  • Need of labour analgesia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Instrumental delivery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Side effects: nausea, vomit, diarrhea, postpartum haemorrhage [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Maternal death [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Meconium [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Non-reassuring fetal heart rate [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Apgar scores less than 7 at 1st and 5th minute [ Time Frame: 1st and 5th minutes after delivery ] [ Designated as safety issue: Yes ]
  • Admission at neonatal intensive care unit [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Perinatal or neonatal death [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Neonatal encephalopathy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Women not satisfied with route of drug administration [ Time Frame: 48 hours after delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Titrated Misoprostol Solution 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.
Other Names:
  • Prostokos
  • Cytotec
Active Comparator: Vaginal Misoprostol Drug: Misoprostol
Vaginal tablets will have 25mcg of misoprostol or placebo.
Other Names:
  • Prostokos
  • Cytotec

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992524

Locations
Brazil
Instituto de Medicina Integral Professor Fernando Figueira (IMIP)
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Instituto de Saúde Elpidio de Almeida
Universidade Federal do Ceara
Investigators
Study Chair: Alex SR Souza, Phd student Professor Fernando Figueira Integral Medicine Institute
Study Director: Melania MR Amorim, Phd Professor Fernando Figueira Integral Medicine Institute
Principal Investigator: Aurélio AR Costa, PhD Professor Fernando Figueira Integral Medicine Institute
  More Information

No publications provided by Instituto Materno Infantil Prof. Fernando Figueira

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alex Sandro Rolland de Souza, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
ClinicalTrials.gov Identifier: NCT00992524     History of Changes
Other Study ID Numbers: ORALTIMI
Study First Received: October 8, 2009
Last Updated: June 22, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Misoprostol
Labor, Obstetric
Labor, Induced

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 28, 2014