Induction of LaborPhase 4NCT02762942
Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
A Phase 4 study testing Misoprostol and Foley catheter in people with Induction of Labor and Cervical Ripening, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induction of Labor, Cervical Ripening, Pregnancy
- What is being tested?
- Misoprostol and Foley catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Sep 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Cephalic presentation
- Reassuring fetal heart rate pattern
- Intact membranes
- Bishop score less than 6
Who cannot join
- Severe preeclampsia
- Prematurity ( < 37 weeks gestation dated by first trimester ultrasound)
- Previous cesarean section or previous uterine surgery
- Intrauterine growth restriction
- Premature rupture of membranes
- Maternal colonization with Streptococcus Agalactiae at any time during pregnancy
Show all 10Show fewer
- Multifetal pregnancy
- Breech presentation
- Stillbirth
- Any contraindication for vaginal delivery
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Angels Vives Argilagós, MI, 937310007 ext. 7098, MAVives@cst.cat
Marino Romero Ramirez, MI, 937310007 ext. 3319, marino.rora@gmail.com
About this study
Official title: Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.
- Conditions
- Induction of Labor, Cervical Ripening, Pregnancy
- Being tested
- Misoprostol, Foley catheter
- Keywords
- cervical ripening, misoprostol, supracervical balloon, Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Misofar
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
Foley catheterDevice
Also called Supracervical balloon
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Vaginal misoprostol alone | Active comparator | Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols Receives: Drug: Misoprostol |
| Vaginal misoprostol + Foley catheter | Experimental | Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol. Receives: Drug: Misoprostol; Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction to delivery time
Measured: 1 year
Secondary outcomes (18)
Bishop score at 12 hours from the onset of induction
Measured: 1 year
Bishop score at 24 hours from the onset of induction
Measured: 1 year
Number of doses of misoprostol required
Measured: 1 year
Percentage of pregnant women requiring oxytocin
Measured: 1 year
Maximum dosage of oxytocin given (mU / min)
Measured: 1 year
Percentage of pregnant women requiring epidural analgesia
Measured: 1 year
Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations
Measured: 1 year
Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations
Measured: 1 year
Percentage of pregnant women with intrapartum fever
Measured: 1 year
Percentage of pregnant women with maternal side effects
Measured: 1 year
Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction
Measured: 1 year
Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction
Measured: through study completion
Total rate of cesarean section
Measured: 1 year
Percentage of cesarean sections for failed induction
Measured: 1 year
Percentage of cesarean sections for nonreassuring fetal status
Measured: 1 year
Neonatal intensive care unit admission
Measured: 1 year
Apgar score at 5 minutes
Measured: 1 year
Umbilical artery ph
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (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 Induction of 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dra Angels Vives Argilagós, Consorci Sanitari de Terrassa
- Investigators
- Àngels Vives Argilagós, MD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762942
- Sponsor's protocol ID
- 2015-002061-29
- Other IDs
- 2015-002061-29, 2015
- Status last verified
- May 2016
- First submitted
- 26 Apr 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
- ClinicalTrials.gov ID
- NCT02762942
- Acronym / sponsor ID
- 2015-002061-29
- Conditions
- Induction of Labor, Cervical Ripening, Pregnancy
- Keywords
- cervical ripening, misoprostol, supracervical balloon, Foley catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 5 May 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.
Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal misoprostol alone | Active comparator | Drug: MisoprostolWomen in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols |
| Vaginal misoprostol + Foley catheter | Experimental | Drug: Misoprostol, Device: Foley catheterWomen in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Cephalic presentation
- Reassuring fetal heart rate pattern
- Intact membranes
- Bishop score less than 6
Key exclusion criteria (10 listed)
- Severe preeclampsia
- Prematurity ( < 37 weeks gestation dated by first trimester ultrasound)
- Previous cesarean section or previous uterine surgery
- Intrauterine growth restriction
- Premature rupture of membranes
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: MisofarAdministration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses | Drug | Vaginal misoprostol + Foley catheter, Vaginal misoprostol alone |
| Foley catheterAlso: Supracervical balloonInsertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours | Device | Vaginal misoprostol + Foley catheter |
Primary outcome
Induction to delivery time
Time frame: 1 year
18 secondary outcomes
Bishop score at 12 hours from the onset of induction
Time frame: 1 year
Bishop score at 24 hours from the onset of induction
Time frame: 1 year
Number of doses of misoprostol required
Time frame: 1 year
Percentage of pregnant women requiring oxytocin
Time frame: 1 year
Maximum dosage of oxytocin given (mU / min)
Time frame: 1 year
Percentage of pregnant women requiring epidural analgesia
Time frame: 1 year
Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations
Time frame: 1 year
Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations
Time frame: 1 year
Percentage of pregnant women with intrapartum fever
Time frame: 1 year
Percentage of pregnant women with maternal side effects
Time frame: 1 year
Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction
Time frame: 1 year
Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction
Time frame: through study completion
Total rate of cesarean section
Time frame: 1 year
Percentage of cesarean sections for failed induction
Time frame: 1 year
Percentage of cesarean sections for nonreassuring fetal status
Time frame: 1 year
Neonatal intensive care unit admission
Time frame: 1 year
Apgar score at 5 minutes
Time frame: 1 year
Umbilical artery ph
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: No
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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.
Àngels Vives Argilagós, MD principal investigator
Consorci Sanitari de Terrassa
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 and Foley catheter in people with Induction of Labor and Cervical Ripening, run by Consorci Sanitari de Terrassa 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 5 inclusion and 10 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 May 2016. 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 Àngels Vives Argilagós, MD (+34 937310007 ext. 7098, MAVives@cst.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction to delivery time (time frame: 1 year). 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 NCT02762942, 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 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.