Sublingual Misoprostol for Induction of Labor (SUBMISO)

September 15, 2019 updated by: Daniele Sofia de Moraes Barros Gattas, Professor Fernando Figueira Integral Medicine Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Cytotec
  • Prostokos
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 Names:
  • Prostokos Cytotec

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of taquissistoly
Time Frame: 48 hours
during 48 hours the presence of taquissistoly will be observed
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hyperstimulation Syndrome
Time Frame: 48 hours
during 48 hours the presence of hyperstimulation syndrome will be observed
48 hours
changes in the cervix at 12 and 24 hours
Time Frame: 12 and 24 hours
changes in the cervix
12 and 24 hours
failure to achieve vaginal delivery within 12 and 24 hours
Time Frame: 12 and 24 hours
failure to achieve vaginal delivery
12 and 24 hours
the mother's preferred route of administration
Time Frame: after 48 hours
Ask to mother what route of administratios was the best for her
after 48 hours
time between the first dose and the onset of labour and delivery
Time Frame: after 48 hours
to avaluete the time between the first dose and the onset of labour and delivery
after 48 hours
duration of labour
Time Frame: after 48 hours
to avaluete the time of duration of labour
after 48 hours
need for oxytocin
Time Frame: after 48 hours
to avaluete the use of oxytocin during the labour
after 48 hours
failed induction of labour
Time Frame: after 48 hours
to avaluete the faliled induction of labor
after 48 hours
Caesarean section and the indications for this procedure
Time Frame: after 48 hours
to avaluete the number of Caesarean section and the indications for this procedure
after 48 hours
need for epidural anaesthesia
Time Frame: after 48 hours
to avaluete the need for epidural anaesthesia
after 48 hours
maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);
Time Frame: after 48 hours
to avaluete if occurred any case of maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);
after 48 hours
severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death
Time Frame: 48 hours
to avaluete severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death
48 hours
meconium in the amniotic fluid
Time Frame: 48 hours
to avaluete meconium in the amniotic fluid
48 hours
non-reassuring foetal heart rate
Time Frame: 48 hours
non-reassuring foetal heart rate
48 hours
one- and five-minute Apgar scores <7
Time Frame: after 48 hours
to avaluete one- and five-minute Apgar scores <7
after 48 hours
admission of the newborn to a neonatal intensive care unit
Time Frame: after 48 hours
to avaluete admission of the newborn to a neonatal intensive care unit
after 48 hours
need for neonatal resuscitation
Time Frame: after 48 hours
to avaluete the need for neonatal resuscitation
after 48 hours
severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.
Time Frame: after 48 hours
to avaluete severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.
after 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Professor Fernando Figueira Integral Medicine Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maternidade Escola Assis Chateaubriand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SUBMISO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

After publication in scientific journal

IPD Sharing Supporting Information Type

  • Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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