Labor, InducedNCT07237880
Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
A study testing Papaverine 80 mg IV in people with Labor, Induced, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This prospective, randomized, double-blind controlled trial aims to evaluate whether intravenous papaverine, administered immediately after the removal of a double-balloon catheter used for cervical ripening, can shorten the duration of labor in term pregnant women undergoing induction of labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Papaverine 80 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Apr 2025to 22 Apr 2027
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant individuals aged 18-50 years
- Singleton pregnancy
- Gestational age 37-42 weeks
- Admission for induction of labor with a double-balloon catheter
- Planned vaginal delivery
- Ability to provide informed consent
Who cannot join
- Previous cesarean delivery
- Multiple gestation
- Contraindication to vaginal delivery
- Known hypersensitivity to papaverine
- Known major fetal anomaly
- Any condition requiring immediate delivery or precluding safe participation (as determined by the treating physician)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera
ESTHER MAOR-SAGIE, 972-04-7744248, estimaorsagie@gmail.com
About this study
This prospective, randomized, double-blind controlled trial aims to evaluate whether intravenous papaverine, administered immediately after the removal of a double-balloon catheter used for cervical ripening, can shorten the duration of labor in term pregnant women undergoing induction of labor. Papaverine is an antispasmodic medication that relaxes smooth muscle and is commonly used in obstetrics, although its effect on labor progression following mechanical cervical ripening has not been fully studied.
Eligible participants include nulliparous and multiparous women with a singleton pregnancy at 37-42 weeks, admitted for induction of labor with a double-balloon catheter. After catheter removal, participants will be randomized in a 1:1 ratio to receive either 80 mg intravenous papaverine or placebo (normal saline), administered by the midwife who is not involved in clinical decision-making. Clinical staff and participants will remain blinded to group allocation.
Read more
The primary outcomes are the time from drug administration to complete cervical dilation and the duration of the second stage of labor. Secondary outcomes include mode of delivery, maternal complications (such as perineal tears and postpartum hemorrhage), oxytocin augmentation duration and maximum dose, and neonatal outcomes.
This study seeks to determine whether papaverine can safely and effectively reduce labor duration following mechanical cervical ripening.
- Conditions
- Labor, Induced
- Being tested
- Papaverine 80 mg IV, Placebo (Normal Saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papaverine 80 mg IVDrug
Single intravenous dose of 80 mg papaverine administered immediately after removal of the double-balloon cervical ripening catheter. The medication is given by the midwife as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation according to standard labor management.
Placebo (Normal Saline)Drug
Single intravenous dose of normal saline administered immediately after removal of the double-balloon cervical ripening catheter. The placebo is administered in an identical manner to the papaverine intervention as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Arm Name: Papaverine | Experimental | "Participants receive 80 mg intravenous papaverine immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation." Receives: Drug: Papaverine 80 mg IV |
| Arm Type: Placebo Comparator | Placebo comparator | "Participants receive intravenous normal saline immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation." Receives: Drug: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from study drug administration to complete cervical dilation
Time in hours from intravenous administration of papaverine or placebo after removal of the double-balloon catheter until complete cervical dilation (10 cm), as documented in the partogram/electronic medical record.
Measured: From study drug administration to complete cervical dilation, up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start22 Apr 2025
- Primary completion22 Apr 2027 (estimated)
- Study completion22 Apr 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Esther Maor-Sagie, MD, Principal investigator, Hillel Yaffe Medical CenterRinat Gabbay-Benziv, Prof, Study director, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237880
- Sponsor's protocol ID
- 0100-24-HYMC
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
- ClinicalTrials.gov ID
- NCT07237880
- Acronym / sponsor ID
- 0100-24-HYMC
- Conditions
- Labor, Induced
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 20 Nov 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.
This prospective, randomized, double-blind controlled trial aims to evaluate whether intravenous papaverine, administered immediately after the removal of a double-balloon catheter used for cervical ripening, can shorten the duration of labor in term pregnant women undergoing induction of labor. Papaverine is an antispasmodic medication that relaxes smooth muscle and is commonly used in obstetrics, although its effect on labor progression following mechanical cervical ripening has not been fully studied.
Eligible participants include nulliparous and multiparous women with a singleton pregnancy at 37-42 weeks, admitted for induction of labor with a double-balloon catheter. After catheter removal, participants will be randomized in a 1:1 ratio to receive either 80 mg intravenous papaverine or placebo (normal saline), administered by the midwife who is not involved in clinical decision-making. Clinical staff and participants will remain blinded to group allocation.
The primary outcomes are the time from drug administration to complete cervical dilation and the duration of the second stage of labor. Secondary outcomes include mode of delivery, maternal complications (such as perineal tears and postpartum hemorrhage), oxytocin augmentation duration and maximum dose, and neonatal outcomes.
This study seeks to determine whether papaverine can safely and effectively reduce labor duration following mechanical cervical ripening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Name: Papaverine | Experimental | Drug: Papaverine 80 mg IV"Participants receive 80 mg intravenous papaverine immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation." |
| Arm Type: Placebo Comparator | Placebo comparator | Drug: Placebo (Normal Saline)"Participants receive intravenous normal saline immediately after removal of the double-balloon catheter, together with initiation of oxytocin augmentation." |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant individuals aged 18-50 years
- Singleton pregnancy
- Gestational age 37-42 weeks
- Admission for induction of labor with a double-balloon catheter
- Planned vaginal delivery
Key exclusion criteria (6 listed)
- Previous cesarean delivery
- Multiple gestation
- Contraindication to vaginal delivery
- Known hypersensitivity to papaverine
- Known major fetal anomaly
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 |
|---|---|---|
| Papaverine 80 mg IVSingle intravenous dose of 80 mg papaverine administered immediately after removal of the double-balloon cervical ripening catheter. The medication is given by the midwife as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation according to standard labor management. | Drug | Arm Name: Papaverine |
| Placebo (Normal Saline)Single intravenous dose of normal saline administered immediately after removal of the double-balloon cervical ripening catheter. The placebo is administered in an identical manner to the papaverine intervention as part of the randomized, double-blind protocol, followed by initiation of oxytocin augmentation. | Drug | Arm Type: Placebo Comparator |
Primary outcome
Time from study drug administration to complete cervical dilation
Time frame: From study drug administration to complete cervical dilation, up to 24 hours.
Time in hours from intravenous administration of papaverine or placebo after removal of the double-balloon catheter until complete cervical dilation (10 cm), as documented in the partogram/electronic medical record.
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 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Esther Maor-Sagie, MD principal investigator
Hillel Yaffe Medical Center
Rinat Gabbay-Benziv, Prof study director
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papaverine 80 mg IV in people with Labor, Induced, run by Hillel Yaffe 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 6 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 6 Jan 2026. 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. 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?
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 Esther Maor-Sagie, MD (9727744248, estimaorsagie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from study drug administration to complete cervical dilation (time frame: From study drug administration to complete cervical dilation, 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 6 Jan 2026.