Labor, InducedOTISMISONCT00992524
Oral Titrated Misoprostol for Induction of Labour
A study testing Misoprostol in people with Labor, Induced, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Indication for labour induction
- Term pregnancy with alive fetus
- Bishop score less than six
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira (IMIP)
Recife, Pernambuco, 50070-550
About this study
Official title: Oral Misoprostol Titrated Solution Versus Vaginal Misoprostol for Induction of Labour: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Labor, Induced
- Being tested
- Misoprostol
- Keywords
- Misoprostol, Labor, Obstetric, Labor, Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Prostokos, Cytotec
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.
MisoprostolDrug
Also called Prostokos, Cytotec
Vaginal tablets will have 25mcg of misoprostol or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Oral Titrated Misoprostol Solution | Active comparator | Not described Receives: Drug: Misoprostol |
| Vaginal Misoprostol | Active comparator | Not described Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery
Measured: 24 hours
Hyperstimulation syndrome
Measured: 24 hours
Cesarean section
Measured: 3 days
Severe neonatal morbidity or perinatal death
Measured: 28 days
Serious maternal morbidity or maternal death
Measured: 42
Secondary outcomes (18)
Need of oxytocin for augmentation of labour
Measured: 48 hours
Number of doses needed to bring on labour
Measured: 48 hours
Interval from 1st dose to labour
Measured: 48 hours
Interval from 1st dose to delivery
Measured: 48 hours
Failed induction
Measured: 72 hours
Tachysystole
Measured: 48 hours
Uterine rupture
Measured: 72 houras
Need of labour analgesia
Measured: 48 hours
Instrumental delivery
Measured: 48 hours
Side effects: nausea, vomit, diarrhea, postpartum haemorrhage
Measured: 72 hours
Maternal death
Measured: 42 days
Meconium
Measured: 72 hours
Non-reassuring fetal heart rate
Measured: 72 hours
Apgar scores less than 7 at 1st and 5th minute
Measured: 1st and 5th minutes after delivery
Admission at neonatal intensive care unit
Measured: 28 days
Perinatal or neonatal death
Measured: 28 days
Neonatal encephalopathy
Measured: 28 days
Women not satisfied with route of drug administration
Measured: 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor, InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Saúde Elpidio de Almeida, Universidade Federal do Ceara
- Investigators
- Alex SR Souza, Phd student, Study chair, Professor Fernando Figueira Integral Medicine InstituteMelania MR Amorim, Phd, Study director, Professor Fernando Figueira Integral Medicine InstituteAurélio AR Costa, PhD, Principal investigator, Professor Fernando Figueira Integral Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992524
- Sponsor's protocol ID
- ORALTIMI
- Acronym
- OTISMISO
- Status last verified
- Oct 2009
- First submitted
- 8 Oct 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Souza AS, Feitosa FE, Costa AA, Pereira AP, Carvalho AS, Paixao RM, Katz L, Amorim MM. Titrated oral misoprostol solution versus vaginal misoprostol for labor induction. Int J Gynaecol Obstet. 2013 Dec;123(3):207-12. doi: 10.1016/j.ijgo.2013.06.028. Epub 2013 Sep 3.
PubMed 24112746Orange FA, Passini R Jr, Melo AS, Katz L, Coutinho IC, Amorim MM. Combined spinal-epidural anesthesia and non-pharmacological methods of pain relief during normal childbirth and maternal satisfaction: a randomized clinical trial. Rev Assoc Med Bras (1992). 2012 Jan-Feb;58(1):112-7.
PubMed 22392325
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Misoprostol Titrated Solution Versus Vaginal Misoprostol for Induction of Labour: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00992524
- Acronym / sponsor ID
- OTISMISO / ORALTIMI
- Conditions
- Labor, Induced
- Keywords
- Misoprostol, Labor, Obstetric, Labor, Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Collaborators
- Instituto de Saúde Elpidio de Almeida, Universidade Federal do Ceara
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Titrated Misoprostol Solution | Active comparator | Drug: Misoprostol |
| Vaginal Misoprostol | Active comparator | Drug: Misoprostol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Indication for labour induction
- Term pregnancy with alive fetus
- Bishop score less than six
Key exclusion criteria (8 listed)
- Age less than 18 years
- Previous uterine scar
- Nonvertex presentation
- Non-reassuring fetal status
- Fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: Prostokos, CytotecOral 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. | Drug | Oral Titrated Misoprostol Solution |
| MisoprostolAlso: Prostokos, CytotecVaginal tablets will have 25mcg of misoprostol or placebo. | Drug | Vaginal Misoprostol |
Primary outcome
Vaginal delivery
Time frame: 24 hours
Hyperstimulation syndrome
Time frame: 24 hours
Cesarean section
Time frame: 3 days
Severe neonatal morbidity or perinatal death
Time frame: 28 days
Serious maternal morbidity or maternal death
Time frame: 42
18 secondary outcomes
Need of oxytocin for augmentation of labour
Time frame: 48 hours
Number of doses needed to bring on labour
Time frame: 48 hours
Interval from 1st dose to labour
Time frame: 48 hours
Interval from 1st dose to delivery
Time frame: 48 hours
Failed induction
Time frame: 72 hours
Tachysystole
Time frame: 48 hours
Uterine rupture
Time frame: 72 houras
Need of labour analgesia
Time frame: 48 hours
Instrumental delivery
Time frame: 48 hours
Side effects: nausea, vomit, diarrhea, postpartum haemorrhage
Time frame: 72 hours
Maternal death
Time frame: 42 days
Meconium
Time frame: 72 hours
Non-reassuring fetal heart rate
Time frame: 72 hours
Apgar scores less than 7 at 1st and 5th minute
Time frame: 1st and 5th minutes after delivery
Admission at neonatal intensive care unit
Time frame: 28 days
Perinatal or neonatal death
Time frame: 28 days
Neonatal encephalopathy
Time frame: 28 days
Women not satisfied with route of drug administration
Time frame: 48 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Derived from this study: PubMed 24112746Souza AS, Feitosa FE, Costa AA, Pereira AP, Carvalho AS, Paixao RM, Katz L, Amorim MM. Titrated oral misoprostol solution versus vaginal misoprostol for labor induction. Int J Gynaecol Obstet. 2013 Dec;123(3):207-12. doi: 10.1016/j.ijgo.2013.06.028. Epub 2013 Sep 3.
- Derived from this study: PubMed 22392325Orange FA, Passini R Jr, Melo AS, Katz L, Coutinho IC, Amorim MM. Combined spinal-epidural anesthesia and non-pharmacological methods of pain relief during normal childbirth and maternal satisfaction: a randomized clinical trial. Rev Assoc Med Bras (1992). 2012 Jan-Feb;58(1):112-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex SR Souza, Phd student study chair
Professor Fernando Figueira Integral Medicine Institute
Melania MR Amorim, Phd study director
Professor Fernando Figueira Integral Medicine Institute
Aurélio AR Costa, PhD principal investigator
Professor Fernando Figueira Integral Medicine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Labor, Induced, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal delivery (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.