Labor, InducedNCT03928600
Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
A study testing Cervical Foley combined with Misoprostol, Dinoprostone 10mg insert OR and Misoprostol in people with Labor, Induced and Cervical Ripening, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial summary
Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induced, Cervical Ripening
- What is being tested?
- Cervical Foley combined with Misoprostol, Dinoprostone 10mg insert OR and Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2018to 29 Feb 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- full-term (≥ 37 weeks of gestation)
- singleton
- vertex-presenting gestations
- with no contraindication to vaginal delivery
- intact membranes
- Bishop score < 7 and cervical dilation ≤2 cm
Who cannot join
- contraindication for misoprostol
- history of previous caesarean
- rupture of membranes,
- fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, fetal growth restriction)
Trial locations and contacts
1 site in 1 country.
About this study
Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction.
Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice.
The objective is to compare the effectiveness of a combined new method to current guidelines of our department
Read the detailed description
We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone).
Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-
- Conditions
- Labor, Induced, Cervical Ripening
- Being tested
- Cervical Foley combined with Misoprostol, Dinoprostone 10mg insert OR, Misoprostol
- Keywords
- induction of labor, cervical ripening, combined methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Foley combined with MisoprostolCombination product
Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug
Dinoprostone 10mg insert ORDrug
Application for 24h of Dinoprostone 10mg insert
MisoprostolDrug
Application of vaginal misoprostol 25ug 4/4h until 150ug
| Study group | Role | What they receive |
|---|---|---|
| Combined method induction group | Experimental | * 25 micrograms misoprostol vaginal applied placed along with cervical Foley (team will repeat misoprostol application each 4 hours till 6 doses of misoprostol)
* After 4 hours of last misoprostol initiate oxytocin.
* Cervical Foley will be removed after 12h of placement or when fails out. Receives: Combination Product: Cervical Foley combined with Misoprostol |
| Current department guidelines group | Placebo comparator | * Following current department guidelines, as usual, with the method considered more suitable.
* If they opted for vaginal misoprostol, team will insert 25micrograms, repeat application 4/4h, until 150micrograms, after last misoprostol, wait 4 hours before initiating oxytocin.
* If option is vaginal dinoprostone the insert of 10mg is removed after 24h in place. Receives: Drug: Dinoprostone 10mg insert OR; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to delivery
Time to delivery
Measured: 3 days
Secondary outcomes (8)
cesarean delivery rate
cesarean delivery rate
Measured: 3 days
time to active labor
defined as dilation of 6 cm or greater
Measured: 3 days
rate of delivery within 12 hours
rate of delivery within 12 hours
Measured: 12 hours
rate of delivery within 24 hours
rate of delivery within 24 hours
Measured: 24 hours
mean of maternal length of stay
induction to discharge
Measured: average 3 days
indication for cesarean delivery
indication for cesarean delivery
Measured: 3 days
composite maternal morbidity outcome
third- or fourth-degree perineal laceration, blood transfusion, chorioamnionitis, endometritis, wound infection, venous thromboembolism, hysterectomy, intensive care unit admission or death.
Measured: 6 weeks
composite of neonatal morbidities
SDR, neonatal sepsis, blood transfusion, encephalopathy hypoxic-ischemic, intraventricular hemorrhage of grade III/IV
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Feb 2018
- Primary completion31 Jan 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Polónia Valente, Centro Hospitalar De São João, E.P.E.
- Investigators
- Rita P Valente, MD, Principal investigator, Centro Hospitalar São João, Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928600
- Sponsor's protocol ID
- CES 171-17
- Status last verified
- Jan 2023
- First submitted
- 4 Mar 2019
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Informed Consent Form, Statistical Analysis Plan
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction With a Combined Method (Pharmacologic and Mechanical): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03928600
- Acronym / sponsor ID
- CES 171-17
- Conditions
- Labor, Induced, Cervical Ripening
- Keywords
- induction of labor, cervical ripening, combined methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
Labor induction is a common pregnancy procedure worldwide. Both mechanical and pharmacologic agents are used for induction of labor. These agents reduce the incidence of cesarean delivery in women undergoing induction.
Opposite to old studies of cervical ripening, some recent studies have shown promise in reducing labor time and risk of cesarean delivery with combination methods. The effectiveness of this procedure is of major clinical importance and has a large impact in our quotidian practice.
The objective is to compare the effectiveness of a combined new method to current guidelines of our department
Detailed description
We designed a randomized trial that will compare two groups: misoprostol-cervical Foley simultaneously and the current department guidelines (misoprostol alone/dinoprostone alone).
Inclusion criteria: full-term (≥ 37 weeks of gestation), singleton, vertex-
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined method induction group | Experimental | Combination Product: Cervical Foley combined with Misoprostol* 25 micrograms misoprostol vaginal applied placed along with cervical Foley (team will repeat misoprostol application each 4 hours till 6 doses of misoprostol) * After 4 hours of last misoprostol initiate oxytocin. * Cervical Foley will be removed after 12h of placement or when fails out. |
| Current department guidelines group | Placebo comparator | Drug: Dinoprostone 10mg insert OR, Drug: Misoprostol* Following current department guidelines, as usual, with the method considered more suitable. * If they opted for vaginal misoprostol, team will insert 25micrograms, repeat application 4/4h, until 150micrograms, after last misoprostol, wait 4 hours before initiating oxytocin. * If option is vaginal dinoprostone the insert of 10mg is removed after 24h in place. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- full-term (≥ 37 weeks of gestation)
- singleton
- vertex-presenting gestations
- with no contraindication to vaginal delivery
- intact membranes
Key exclusion criteria (4 listed)
- contraindication for misoprostol
- history of previous caesarean
- rupture of membranes,
- fetal or maternal morbidities (fetal major abnormalities, FIGO definition of pathological CTG, HELLP syndrome, preeclampsia or hypertension with severe features, 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 |
|---|---|---|
| Cervical Foley combined with MisoprostolPlacement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug | Combination product | Combined method induction group |
| Dinoprostone 10mg insert ORApplication for 24h of Dinoprostone 10mg insert | Drug | Current department guidelines group |
| MisoprostolApplication of vaginal misoprostol 25ug 4/4h until 150ug | Drug | Current department guidelines group |
Primary outcome
Time to delivery
Time frame: 3 days
Time to delivery
8 secondary outcomes
cesarean delivery rate
Time frame: 3 days
time to active labor
Time frame: 3 days
rate of delivery within 12 hours
Time frame: 12 hours
rate of delivery within 24 hours
Time frame: 24 hours
mean of maternal length of stay
Time frame: average 3 days
indication for cesarean delivery
Time frame: 3 days
composite maternal morbidity outcome
Time frame: 6 weeks
composite of neonatal morbidities
Time frame: 30 days
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 Jan 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed Consent Form, Statistical Analysis Plan
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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.
Rita P Valente, MD principal investigator
Centro Hospitalar São João, Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Foley combined with Misoprostol, Dinoprostone 10mg insert OR and Misoprostol in people with Labor, Induced and Cervical Ripening, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
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 6 inclusion and 4 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 Jan 2023. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
Time to delivery (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2023.