Labor, InducedPhase 4NCT02486679
A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction
A Phase 4 study testing Prostin (PGE2) tablets and Foley catheter in people with Labor, Induced, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening. 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
- What is being tested?
- Prostin (PGE2) tablets and Foley catheter
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton term pregnancies (>37 weeks), vertex presentation
- Intact membranes
- Low Bishop score (<7)
- First, second or third delivery
- Medical indication for induction
- Viable fetus
Who cannot join
- Contraindication for vaginal delivery, for PGE2 or foley catheter
- Gestational age<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon
Hadas Ganer Herman, MD, 972526206696, hadassganer@yahoo.com
About this study
Official title: Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial
A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.
- Conditions
- Labor, Induced
- Being tested
- Prostin (PGE2) tablets, Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostin (PGE2) tabletsDrug
Foley catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| PGE2 | Active comparator | Patients allocated to vaginal PGE2 (Prostin) for cervical ripening Receives: Drug: Prostin (PGE2) tablets |
| Foley catheter | Active comparator | Patients allocated to foley catheter placement for cervical ripening Receives: Device: Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to active labor
Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation >4 cm and/or cervical effacement>80%
Measured: Post labor- up to 24 hours
Secondary outcomes (4)
Delivery within 24 hours
Delivery within 24 hours from foley catheter /first PGE2 tablet palcement
Measured: post-labor - up to 24 hours
Cesarean section rate
Delivery via cesarean section
Measured: post labor - up to 24 hours
Maternal complications
Documented complications during labor, including: excessive hemmorhage, infection (chorioamnionitis)
Measured: participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days
Neonatal complications
Documented complications such as non-reassuring fetal heart rate, fetal pH, NICU admission, early neonatal sepsis
Measured: Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hadas Ganer Herman, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486679
- Sponsor's protocol ID
- 0095-15-WOMC
- Status last verified
- Apr 2016
- First submitted
- 22 Jun 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02486679
- Acronym / sponsor ID
- 0095-15-WOMC
- Conditions
- Labor, Induced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jul 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 1 Jul 2015 (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.
A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGE2 | Active comparator | Drug: Prostin (PGE2) tabletsPatients allocated to vaginal PGE2 (Prostin) for cervical ripening |
| Foley catheter | Active comparator | Device: Foley catheterPatients allocated to foley catheter placement for cervical ripening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton term pregnancies (>37 weeks), vertex presentation
- Intact membranes
- Low Bishop score (<7)
- First, second or third delivery
- Medical indication for induction
Key exclusion criteria (2 listed)
- Contraindication for vaginal delivery, for PGE2 or foley catheter
- Gestational age<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial
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 |
|---|---|---|
| Prostin (PGE2) tablets | Drug | PGE2 |
| Foley catheter | Device | Foley catheter |
Primary outcome
Time to active labor
Time frame: Post labor- up to 24 hours
Hours from foley cather placement or first PGE2 tablet placment to active labor, defined as cervical dilitation >4 cm and/or cervical effacement>80%
4 secondary outcomes
Delivery within 24 hours
Time frame: post-labor - up to 24 hours
Cesarean section rate
Time frame: post labor - up to 24 hours
Maternal complications
Time frame: participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days
Neonatal complications
Time frame: Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
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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.
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 Prostin (PGE2) tablets and Foley catheter in people with Labor, Induced, run by Wolfson Medical Center at 1 site in Israel.
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 2 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 29 Apr 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 Israel. 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 Hadas Ganer Herman, MD (972526206696, hadassganer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to active labor (time frame: Post labor- up to 24 hours). 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 29 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.