Induction of LaborPhase 4NCT06803992
Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter
A Phase 4 study testing Dinoprostone vaginal insert and Dinoprostone gel and Foley catheter balloon in people with Induction of Labor, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Dinoprostone vaginal insert and Dinoprostone gel and Foley catheter balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Apr 2025to 29 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women at term (37 weeks of gestation or more) with singleton
- pregnancies that are intended for IOL.
- Initial bishop score <5
- No contraindications to receive either treatment.
- Women who will give informed consent to be included in the study.
- Women at or over the age of 18.
Who cannot join
- Women with a known hypersensitivity or contraindications to Propess / PGE2.
- Parity 5 or more
- Labor contractions more than 4 in 20 min
- Glaucoma
- History of previous uterine surgery
- Hypersensitivity to prostaglandins
Show all 9Show fewer
- Vaginal delivery is contraindicated
- Active cardiac, renal, pulmonary, or hepatic disease
- Severe asthma or pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB).
The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously.
The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
- Conditions
- Induction of Labor
- Being tested
- Dinoprostone vaginal insert, Dinoprostone gel and Foley catheter balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone vaginal insertDrug
Also called Propess
Described in the arm descriptions
Dinoprostone gel and Foley catheter balloonCombination product
Described in the arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| Propess pessary | Experimental | Placement of a slow-release 10 mg dinoprostone insert (propess) in the posterior fornix for up to 24 hours until labor initiation or favorable cervix, followed by amniotomy and oxytocin administration. In a case of failure, induction of labor will be done with either PGE2 gel and/or Foley catheter. Receives: Drug: Dinoprostone vaginal insert |
| Sequential PGE2 vaginal gel and Foley catheter balloon | Experimental | Insertion of 1 mg dinoprostone (PGE2) vaginal gel to the posterior fornix with reassessment up to 6 hours later. If the Bishop score is still less than 5 and there are no more than 4 contractions in 20 minutes of monitoring, an additional PGE2 vaginal gel of 2 mg is inserted. If there are more than 4 contractions in 20 minutes of monitoring or if after up to 6 hours there will be low Bishop score, a 60 ml Foley catheter balloon is placed for 6 to 12 hours or until spontaneous expulsion. When the cervix is favorable, amniotomy and oxytocin administration are followed.
In a case of a failure, induction of labor with Propess will be conducted. Receives: Combination Product: Dinoprostone gel and Foley catheter balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the duration of induction-to-vaginal delivery
measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery.
Measured: from enrollment until final outcome - a month
Secondary outcomes (4)
rate of vaginal delivery in 24 and 48 hours from IOL
the number of participants who had vaginal delivery in 24 and 48 hours from the beginning of the induction-of-labor for both protocols
Measured: from enrollment until final outcome - a month
Number of Participants with Treatment-Related Adverse Events
Maternal -gathering the numbers of participants who had adverse events such as chorioamnionitis, endometritis, postpartum hemorrhage, uterine rupture, Neonatal -gathering the numbers of participants who had adverse events such as uterine hypertonia (contractions exceeding more than two minutes in duration) and/or tachysystole (more than 5 contractions in 10 minutes, averaged over a 30-minute period) with and without decelerations, non-reassuring fetal heart rate according to fetal monitoring, meconium-stained amniotic liquor, umbilical artery pH less than 7.1, Apgar score less than 7 at 5 min, postpartum transfer to neonatal intensive care unit, infection of the newborn
Measured: from enrollment until final outcome - a month
rate of Induction success
the number of participants who had ceasarean section
Measured: from enrollment until final outcome - a month
rate o Cervical ripening success
the duration from the beginning of the induction to bishop score 5
Measured: from enrollment until final outcome - a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start6 Apr 2025
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohar Nachum, HaEmek Medical Center, Israel
- Investigators
- Zohar Nachum, Professor, Study director, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803992
- Sponsor's protocol ID
- 79-23
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
- ClinicalTrials.gov ID
- NCT06803992
- Acronym / sponsor ID
- 79-23
- Conditions
- Induction of Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 31 Jan 2025 (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.
One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB).
The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously.
The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Propess pessary | Experimental | Drug: Dinoprostone vaginal insertPlacement of a slow-release 10 mg dinoprostone insert (propess) in the posterior fornix for up to 24 hours until labor initiation or favorable cervix, followed by amniotomy and oxytocin administration. In a case of failure, induction of labor will be done with either PGE2 gel and/or Foley catheter. |
| Sequential PGE2 vaginal gel and Foley catheter balloon | Experimental | Combination Product: Dinoprostone gel and Foley catheter balloonInsertion of 1 mg dinoprostone (PGE2) vaginal gel to the posterior fornix with reassessment up to 6 hours later. If the Bishop score is still less than 5 and there are no more than 4 contractions in 20 minutes of monitoring, an additional PGE2 vaginal gel of 2 mg is inserted. If there are more than 4 contractions in 20 minutes of monitoring or if after up to 6 hours there will be low Bishop score, a 60 ml Foley catheter balloon is placed for 6 to 12 hours or until spontaneous expulsion. When the cervix is favorable, amniotomy and oxytocin administration are followed. In a case of a failure, induction of labor with Propess will be conducted. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women at term (37 weeks of gestation or more) with singleton
- pregnancies that are intended for IOL.
- Initial bishop score <5
- No contraindications to receive either treatment.
- Women who will give informed consent to be included in the study.
Key exclusion criteria (9 listed)
- Women with a known hypersensitivity or contraindications to Propess / PGE2.
- Parity 5 or more
- Labor contractions more than 4 in 20 min
- Glaucoma
- History of previous uterine surgery
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 |
|---|---|---|
| Dinoprostone vaginal insertAlso: PropessDescribed in the arm descriptions | Drug | Propess pessary |
| Dinoprostone gel and Foley catheter balloonDescribed in the arm descriptions | Combination product | Sequential PGE2 vaginal gel and Foley catheter balloon |
Primary outcome
comparing the duration of induction-to-vaginal delivery
Time frame: from enrollment until final outcome - a month
measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery.
4 secondary outcomes
rate of vaginal delivery in 24 and 48 hours from IOL
Time frame: from enrollment until final outcome - a month
Number of Participants with Treatment-Related Adverse Events
Time frame: from enrollment until final outcome - a month
rate of Induction success
Time frame: from enrollment until final outcome - a month
rate o Cervical ripening success
Time frame: from enrollment until final outcome - a month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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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.
Zohar Nachum, Professor study director
Emek Medical Center
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 Dinoprostone vaginal insert and Dinoprostone gel and Foley catheter balloon in people with Induction of Labor, run by HaEmek Medical Center, Israel 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 9 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zohar Nachum, Professor (+972547696562, nachum.zo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the duration of induction-to-vaginal delivery (time frame: from enrollment until final outcome - a month). 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 1 Dec 2025.