Labor, InducedPhase 4NCT02902653
Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction
A Phase 4 study testing Oral misoprostol, Vaginal misoprostol and Vaginal dinoprostone in people with Labor, Induced, run by Oihane Lapuente Ocamica at 1 site in Spain.
Trial summary
This study evaluates the efficacy and safety of the administration of oral misoprostol versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Oral misoprostol, Vaginal misoprostol and Vaginal dinoprostone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Sep 2020
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women over 18
- single pregnancy
- cephalic presentation
- intact membranes
- unfavorable cervix ( less than 6 Bishop )
- CTGR not reactive decelerative
- Signed informed consent by the patient.
Who cannot join
- prior Cesarean section or previous uterine surgery .
- Allergy or intolerance to any of the study drugs
- stillbirth
- uterine growth restricted fetuses
- contraindication for vaginal delivery
- Anterior placenta
Show all 14Show fewer
- Multiparity
- moderate to severe heart disease
- hypertensive disorders of pregnancy
- Suspected chorioamnionitis
- Coagulation disorders
- history of epileptic seizures
- liver or kidney disease
- Cognitive impairment or bad knowledge of Spanish
Trial locations and contacts
1 site in 1 country.
Oihane Lapuente Ocamica contact
Amanda Lopez Picado contact
Spain1 site, 1 recruiting
- Recruiting
Araba University Hospital
Vitoria-Gasteiz, Basque Country, 01009
Oihane Lapuente Ocamica, OIHANE.LAPUENTEOCAMICA@osakidetza.eus
Amanda Lopez Picado, amanda.lopezpicado@gmail.com
About this study
Official title: Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial
This study evaluates the efficacy and safety of the administration of oral misoprostol versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.
- Conditions
- Labor, Induced
- Being tested
- Oral misoprostol, Vaginal misoprostol, Vaginal dinoprostone
- Keywords
- misoprostol, dinoprostonal, induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral misoprostolDrug
hourly titrated misoprostol
Vaginal misoprostolDrug
Administration of 25 microgs every 6 hours, maximum 150 microgr
Vaginal dinoprostoneDrug
Vaginal delivery system of 10mg of dinoprostone
| Study group | Role | What they receive |
|---|---|---|
| Oral misoprostol | Experimental | Administration of oral misoprostol according to a "3x1" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment Receives: Drug: Oral misoprostol |
| Vaginal misoprostol | Active comparator | vaginal misoprostol, 25 microgs every 4 hours Receives: Drug: Vaginal misoprostol |
| Vaginal dinoprostone | Active comparator | vaginal dinoprostone, 10 mg during 24 hours (maximum) Receives: Drug: Vaginal dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Measured: 24 hours
Secondary outcomes (11)
The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group
Measured: 12 hours
The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group
Measured: 24 hours
The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group
Measured: 12 hours
Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Measured: 24 hours
The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Measured: 24 hours
Compare the percentage of women requiring oxytocin in each group
Measured: 24 hours
The percentage of women in each group having tachysystole
Measured: 24 hours
Compare the number of women suffering from uterine rupture in each group
Measured: 24 hours
The percentage of women in each branch having uterine hypertonia
Measured: 24 hours
Maternal morbility-mortality among pregnant participants
Measured: up to 180 days
Compare fetal or neonatal morbility-mortality among the 3 groups
Measured: up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oihane Lapuente Ocamica
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Oihane Lapuente Ocamica, Basque Health Service
- Investigators
- Oihane Lapuente Ocamica, Principal investigator, OIHANE.LAPUENTEOCAMICA@osakidetza.eus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902653
- Sponsor's protocol ID
- DV-MV-MO
- Status last verified
- Feb 2018
- First submitted
- 7 Sep 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lapuente-Ocamica O, Ugarte L, Lopez-Picado A, Sanchez-Refoyo F, Lasa IL, Echevarria O, Alvarez-Sala J, Farinas A, Bilbao I, Barbero L, Vicarregui J, Hernanz Chaves R, Paz Corral D, Lopez-Lopez JA. Efficacy and safety of administering oral misoprostol by titration compared to vaginal misoprostol and dinoprostone for cervical ripening and induction of labour: study protocol for a randomised clinical trial. BMC Pregnancy Childbirth. 2019 Jan 8;19(1):14. doi: 10.1186/s12884-018-2132-3.
PubMed 30621614
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02902653
- Acronym / sponsor ID
- DV-MV-MO
- Conditions
- Labor, Induced
- Keywords
- misoprostol, dinoprostonal, induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Oihane Lapuente OcamicaOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 16 Sep 2016 (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.
This study evaluates the efficacy and safety of the administration of oral misoprostol versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral misoprostol | Experimental | Drug: Oral misoprostolAdministration of oral misoprostol according to a "3x1" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment |
| Vaginal misoprostol | Active comparator | Drug: Vaginal misoprostolvaginal misoprostol, 25 microgs every 4 hours |
| Vaginal dinoprostone | Active comparator | Drug: Vaginal dinoprostonevaginal dinoprostone, 10 mg during 24 hours (maximum) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women over 18
- single pregnancy
- cephalic presentation
- intact membranes
- unfavorable cervix ( less than 6 Bishop )
Key exclusion criteria (14 listed)
- prior Cesarean section or previous uterine surgery .
- Allergy or intolerance to any of the study drugs
- stillbirth
- uterine growth restricted fetuses
- contraindication for vaginal delivery
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 |
|---|---|---|
| Oral misoprostolhourly titrated misoprostol | Drug | Oral misoprostol |
| Vaginal misoprostolAdministration of 25 microgs every 6 hours, maximum 150 microgr | Drug | Vaginal misoprostol |
| Vaginal dinoprostoneVaginal delivery system of 10mg of dinoprostone | Drug | Vaginal dinoprostone |
Primary outcome
Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time frame: 24 hours
11 secondary outcomes
The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group
Time frame: 12 hours
The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group
Time frame: 24 hours
The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group
Time frame: 12 hours
Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time frame: 24 hours
The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Time frame: 24 hours
Compare the percentage of women requiring oxytocin in each group
Time frame: 24 hours
The percentage of women in each group having tachysystole
Time frame: 24 hours
Compare the number of women suffering from uterine rupture in each group
Time frame: 24 hours
The percentage of women in each branch having uterine hypertonia
Time frame: 24 hours
Maternal morbility-mortality among pregnant participants
Time frame: up to 180 days
Compare fetal or neonatal morbility-mortality among the 3 groups
Time frame: up to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 30621614Lapuente-Ocamica O, Ugarte L, Lopez-Picado A, Sanchez-Refoyo F, Lasa IL, Echevarria O, Alvarez-Sala J, Farinas A, Bilbao I, Barbero L, Vicarregui J, Hernanz Chaves R, Paz Corral D, Lopez-Lopez JA. Efficacy and safety of administering oral misoprostol by titration compared to vaginal misoprostol and dinoprostone for cervical ripening and induction of labour: study protocol for a randomised clinical trial. BMC Pregnancy Childbirth. 2019 Jan 8;19(1):14. doi: 10.1186/s12884-018-2132-3.
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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.
Oihane Lapuente Ocamica contact
Amanda Lopez Picado contact
Oihane Lapuente Ocamica principal investigator
OIHANE.LAPUENTEOCAMICA@osakidetza.eus
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 Oral misoprostol, Vaginal misoprostol and Vaginal dinoprostone in people with Labor, Induced, run by Oihane Lapuente Ocamica at 1 site in Spain.
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 12 Feb 2018. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oihane Lapuente Ocamica (OIHANE.LAPUENTEOCAMICA@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone) (time frame: 24 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 NCT02902653, which also lists 1 linked publication.
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 12 Feb 2018.