LaborPhase 4SUBMISONCT01406392
Sublingual Misoprostol for Induction of Labor
A Phase 4 study testing Misoprostol 25mcg and Sublingual Misoprostol in people with Labor and Induced, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Misoprostol 25mcg and Sublingual Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2014to 30 Nov 2016
- Phase
- Phase 4
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Indication for labour induction
- Term pregnancy with alive fetus
- Bishop score less than six
Who cannot join
- 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: 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.
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 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.
- Being tested
- Misoprostol 25mcg, Sublingual Misoprostol
- Keywords
- Misoprostol, Sublingual, Induced, Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 25mcgDrug
Also called Prostokos Cytotec
Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.
Sublingual MisoprostolDrug
Also called Prostokos, Cytotec
Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets
| Study group | Role | What they receive |
|---|---|---|
| Sublingual Misoprostol 12,5mcg | Active comparator | Sublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets. Receives: Drug: Sublingual Misoprostol |
| Vaginal Misoprostol 25 mcg | Active comparator | 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. Receives: Drug: Misoprostol 25mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of taquissistoly
during 48 hours the presence of taquissistoly will be observed
Measured: 48 hours
Secondary outcomes (18)
Hyperstimulation Syndrome
during 48 hours the presence of hyperstimulation syndrome will be observed
Measured: 48 hours
changes in the cervix at 12 and 24 hours
changes in the cervix
Measured: 12 and 24 hours
failure to achieve vaginal delivery within 12 and 24 hours
failure to achieve vaginal delivery
Measured: 12 and 24 hours
the mother's preferred route of administration
Ask to mother what route of administratios was the best for her
Measured: after 48 hours
time between the first dose and the onset of labour and delivery
to avaluete the time between the first dose and the onset of labour and delivery
Measured: after 48 hours
duration of labour
to avaluete the time of duration of labour
Measured: after 48 hours
need for oxytocin
to avaluete the use of oxytocin during the labour
Measured: after 48 hours
failed induction of labour
to avaluete the faliled induction of labor
Measured: after 48 hours
Caesarean section and the indications for this procedure
to avaluete the number of Caesarean section and the indications for this procedure
Measured: after 48 hours
need for epidural anaesthesia
to avaluete the need for epidural anaesthesia
Measured: after 48 hours
maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);
to avaluete if occurred any case of maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);
Measured: after 48 hours
severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death
to avaluete severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death
Measured: 48 hours
meconium in the amniotic fluid
to avaluete meconium in the amniotic fluid
Measured: 48 hours
non-reassuring foetal heart rate
non-reassuring foetal heart rate
Measured: 48 hours
one- and five-minute Apgar scores <7
to avaluete one- and five-minute Apgar scores <7
Measured: after 48 hours
admission of the newborn to a neonatal intensive care unit
to avaluete admission of the newborn to a neonatal intensive care unit
Measured: after 48 hours
need for neonatal resuscitation
to avaluete the need for neonatal resuscitation
Measured: after 48 hours
severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.
to avaluete severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.
Measured: after 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study start1 Jul 2014
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
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 LaborStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Maternidade Escola Assis Chateaubriand
- Responsible party
- Principal investigator, Daniele Sofia de Moraes Barros Gattas, Professor Fernando Figueira Integral Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406392
- Sponsor's protocol ID
- SUBMISO
- Acronym
- SUBMISO
- Status last verified
- Sep 2019
- First submitted
- 29 Jul 2011
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gattas DSMB, de Amorim MMR, Feitosa FEL, da Silva-Junior JR, Ribeiro LCG, Souza GFA, Souza ASR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial. Reprod Health. 2020 Apr 10;17(1):47. doi: 10.1186/s12978-020-0901-8.
PubMed 32272959Gattas DSMB, da Silva Junior JR, Souza ASR, Feitosa FE, de Amorim MMR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial protocol. Reprod Health. 2018 Apr 18;15(1):65. doi: 10.1186/s12978-018-0508-5.
PubMed 29669596
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol 12,5 mcg Versus Vaginal Misoprostol 25 mcg for Induction of Labour of Alive and Term Fetus : Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01406392
- Acronym / sponsor ID
- SUBMISO / SUBMISO
- Keywords
- Misoprostol, Sublingual, Induced, Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Maternidade Escola Assis Chateaubriand
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 1 Aug 2011 (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 a sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term 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 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 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 |
|---|---|---|
| Sublingual Misoprostol 12,5mcg | Active comparator | Drug: Sublingual MisoprostolSublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets. |
| Vaginal Misoprostol 25 mcg | Active comparator | Drug: Misoprostol 25mcgVaginal 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Indication for labour induction
- Term pregnancy with alive fetus
- Bishop score less than six
Key exclusion criteria (7 listed)
- Previous uterine scar
- Nonvertex presentation
- Non-reassuring fetal status
- Fetal anomalies
- Fetal growth restriction
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 |
|---|---|---|
| Misoprostol 25mcgAlso: Prostokos CytotecVaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. | Drug | Vaginal Misoprostol 25 mcg |
| Sublingual MisoprostolAlso: Prostokos, CytotecSublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets | Drug | Sublingual Misoprostol 12,5mcg |
Primary outcome
Frequency of taquissistoly
Time frame: 48 hours
during 48 hours the presence of taquissistoly will be observed
18 secondary outcomes
Hyperstimulation Syndrome
Time frame: 48 hours
changes in the cervix at 12 and 24 hours
Time frame: 12 and 24 hours
failure to achieve vaginal delivery within 12 and 24 hours
Time frame: 12 and 24 hours
the mother's preferred route of administration
Time frame: after 48 hours
time between the first dose and the onset of labour and delivery
Time frame: after 48 hours
duration of labour
Time frame: after 48 hours
need for oxytocin
Time frame: after 48 hours
failed induction of labour
Time frame: after 48 hours
Caesarean section and the indications for this procedure
Time frame: after 48 hours
need for epidural anaesthesia
Time frame: after 48 hours
maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);
Time frame: after 48 hours
severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death
Time frame: 48 hours
meconium in the amniotic fluid
Time frame: 48 hours
non-reassuring foetal heart rate
Time frame: 48 hours
one- and five-minute Apgar scores <7
Time frame: after 48 hours
admission of the newborn to a neonatal intensive care unit
Time frame: after 48 hours
need for neonatal resuscitation
Time frame: after 48 hours
severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.
Time frame: after 48 hours
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 18 Sep 2019.
- Derived from this study: PubMed 32272959Gattas DSMB, de Amorim MMR, Feitosa FEL, da Silva-Junior JR, Ribeiro LCG, Souza GFA, Souza ASR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial. Reprod Health. 2020 Apr 10;17(1):47. doi: 10.1186/s12978-020-0901-8.
- Derived from this study: PubMed 29669596Gattas DSMB, da Silva Junior JR, Souza ASR, Feitosa FE, de Amorim MMR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial protocol. Reprod Health. 2018 Apr 18;15(1):65. doi: 10.1186/s12978-018-0508-5.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol 25mcg and Sublingual Misoprostol in people with Labor and Induced, run by Professor Fernando Figueira Integral Medicine Institute 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 7 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 18 Sep 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of taquissistoly (time frame: 48 hours). 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 NCT01406392, 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 18 Sep 2019.