Sublingual Misoprostol for Induction of Labor (SUBMISO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Maternidade Escola Assis Chateaubriand
Information provided by:
Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier:
NCT01406392
First received: July 29, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Labor
Induced
Drug: Misoprostol 25mcg
Drug: Sublingual Misoprostol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Professor Fernando Figueira Integral Medicine Institute:

Primary Outcome Measures:
  • Frequency of taquissistoly [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    during 48 hours the presence of taquissistoly will be observed


Secondary Outcome Measures:
  • Hyperstimulation Syndrome [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    during 48 hours the presence of hyperstimulation syndrome will be observed


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sublingual Misoprostol 12,5mcg
Sublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets.
Drug: Sublingual Misoprostol
Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets
Other Names:
  • Prostokos
  • Cytotec
Active Comparator: Vaginal Misoprostol 25 mcg
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.
Drug: Misoprostol 25mcg
Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.
Other Name: 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 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 three hospitals: Instituto de Medicina Integral Prof. Fernando Figueira, Universidade Federal do Ceará and Instituto de Saúde Elpídio de Almeida and Maternidade da Universidade Federal de Campina Grande, from March 2011 to December 2011. 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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406392

Contacts
Contact: Daniele SM Gattás, MD student 55 81 88986853 djgattas@hotmail.com
Contact: : Alex SR Souza, PhD student 55-81-32217924 alexrolland@uol.com.br

Locations
Brazil
Instituto de Medicina Integral Professor Fernando Figueira (IMIP) Recruiting
Recife, Pernambuco, Brazil, 50070-550
Contact: Daniele SM Gattás, MD Student    55 81 88986853    djgattas@hotmail.com   
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Maternidade Escola Assis Chateaubriand
  More Information

No publications provided

Responsible Party: Daniele Sofia de Moraes Barros Gattás, MD Student
ClinicalTrials.gov Identifier: NCT01406392     History of Changes
Other Study ID Numbers: SUBMISO
Study First Received: July 29, 2011
Last Updated: July 29, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Professor Fernando Figueira Integral Medicine Institute:
Misoprostol
Sublingual
Induced
Labor

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

ClinicalTrials.gov processed this record on April 16, 2014