Induced Vaginal DeliveryPhase 4NCT06550232
IV PAPAVERINE Prior to Propess for Labor Induction
A Phase 4 study testing Papaverine in people with Induced Vaginal Delivery, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval. Researchers will compare drug papaverine to a placebo Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Vaginal Delivery
- What is being tested?
- Papaverine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Aug 2024to 23 Mar 2025
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton term pregnancy
- bishop score
- need for labor induction with PGE2
- vertex presentation
- viable fetus
Who cannot join
- Prelabour rupture of membrane
- Twins pregnancy
- previous cesarean section
- allergy to the study medication
- fetal anomaly contraindications for vaginal delivery
- maternal supraventricular tachicardia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial
The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval.
Researchers will compare drug papaverine to a placebo
Read the detailed description
More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (<6), are prone to higher induction failure rates and are candidates for cervical ripening.
The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
- Conditions
- Induced Vaginal Delivery
- Being tested
- Papaverine, placebo
- Keywords
- labor induction, papaverine, propess, bishop score, induction to delivery interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapaverineDrug
Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline
placeboOther
I.V Sallne
| Study group | Role | What they receive |
|---|---|---|
| papaverine arm | Active comparator | IV-papaverine 80 mg in 100 ml 0.9% saline, once Receives: Drug: Papaverine |
| Control arm | Placebo comparator | I.V 100 ml 0.9% saline Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta Bishop score
The bishop score before and after propess insertion
Measured: 24 hours
the time from propess insertion until delivery
induction to delivery time
Measured: 72 hours
Secondary outcomes (2)
maternal satisfaction scores
maternal satisfaction on 1-5 scale. higher scores mean higher satisfaction
Measured: 24 hours
visual analogue scale score
pain assessment using a 10-point visual analogue scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start12 Aug 2024
- Primary completion23 Mar 2025
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Induced Vaginal DeliveryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Maya Wolf, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550232
- Sponsor's protocol ID
- 0112-24-NHR
- Status last verified
- Jun 2025
- First submitted
- 8 Aug 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors are willing to share the data of the study upon request of the Editors.
Publications
Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, Sass N. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet. 2010 Jul;32(7):346-51. doi: 10.1590/s0100-72032010000700007. Portuguese.
PubMed 21152844Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD009243. doi: 10.1002/14651858.CD009243.pub2.
PubMed 22895986Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labor. Int J Gynaecol Obstet. 2004 Jan;84(1):17-22. doi: 10.1016/s0020-7292(03)00276-5.
PubMed 14698825Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7.
PubMed 24299975Madhu C, Mahavarkar S, Bhave S. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.
PubMed 19644697Yilmaz B, Kart C, Kelekci S, Gokturk U, Sut N, Tarlan N, Mollamahmutoglu L. Meperidine versus valethamate bromide in shortening the duration of active labor. Int J Gynaecol Obstet. 2009 Nov;107(2):126-9. doi: 10.1016/j.ijgo.2009.06.021. Epub 2009 Aug 6.
PubMed 19664769
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of IV PAPAVERINE 80 mg Prior to Propess on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06550232
- Acronym / sponsor ID
- 0112-24-NHR
- Conditions
- Induced Vaginal Delivery
- Keywords
- labor induction, papaverine, propess, bishop score, induction to delivery interval
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 12 Aug 2024 (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.
The investigators aim to evaluate the effect of administering papaverine prior to PGE2 insertion on changes in Bishop-scores and on the induction-to-delivery interval.
Researchers will compare drug papaverine to a placebo
Detailed description
More than 22% of all pregnant women undergo induction of labor. Induction of labor is usually medically indicated for maternal and fetal related conditions; however, elective induction has become more common since the ARRIVE trial. Women with an unfavourable cervix, according to Bishop-score (<6), are prone to higher induction failure rates and are candidates for cervical ripening.
The cervix is composed of connective tissue and smooth-muscle located mainly beneath the internal os. Papaverine is an antispasmodic-musculotropic drug that targets smooth-muscle, resulting in decreased muscle spasm and subsequent smooth-muscle relaxation. The half-life of the drug is in the range of 0.5-2 hours, and its action starts 10 minutes after administration. Short-term use of papaverine during the first trimester has been reported as safe. However, outcome data are lacking of the use of mucosotropic-agents prior to PGE2 (propess) insertion. We will investigate this in a trial in which the co-primary outcomes were the change in Bishop-score after PGE2 extraction and the PGE2 insertion-to-delivery interval
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| papaverine arm | Active comparator | Drug: PapaverineIV-papaverine 80 mg in 100 ml 0.9% saline, once |
| Control arm | Placebo comparator | Other: placeboI.V 100 ml 0.9% saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton term pregnancy
- bishop score
- need for labor induction with PGE2
- vertex presentation
- viable fetus
Key exclusion criteria (6 listed)
- Prelabour rupture of membrane
- Twins pregnancy
- previous cesarean section
- allergy to the study medication
- fetal anomaly contraindications for vaginal delivery
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 |
|---|---|---|
| PapaverineWithin 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline | Drug | papaverine arm |
| placeboI.V Sallne | Other | Control arm |
Primary outcome
Delta Bishop score
Time frame: 24 hours
The bishop score before and after propess insertion
the time from propess insertion until delivery
Time frame: 72 hours
induction to delivery time
2 secondary outcomes
maternal satisfaction scores
Time frame: 24 hours
visual analogue scale score
Time frame: 24 hours
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 26 Jun 2025.
- Background: PubMed 21152844Oliveira MV, Oberst PV, Leite GK, Aguemi A, Kenj G, Leme VD, Sass N. [Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial]. Rev Bras Ginecol Obstet. 2010 Jul;32(7):346-51. doi: 10.1590/s0100-72032010000700007. Portuguese.
- Background: PubMed 22895986Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD009243. doi: 10.1002/14651858.CD009243.pub2.
- Background: PubMed 14698825Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labor. Int J Gynaecol Obstet. 2004 Jan;84(1):17-22. doi: 10.1016/s0020-7292(03)00276-5.
- Background: PubMed 24299975Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7.
- Background: PubMed 19644697Madhu C, Mahavarkar S, Bhave S. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31.
- Background: PubMed 19664769Yilmaz B, Kart C, Kelekci S, Gokturk U, Sut N, Tarlan N, Mollamahmutoglu L. Meperidine versus valethamate bromide in shortening the duration of active labor. Int J Gynaecol Obstet. 2009 Nov;107(2):126-9. doi: 10.1016/j.ijgo.2009.06.021. Epub 2009 Aug 6.
- Individual participant dataSharing planned: Yes. The authors are willing to share the data of the study upon request of the Editors.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Papaverine in people with Induced Vaginal Delivery, run by Western Galilee Hospital-Nahariya 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 5 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: finished, as of the sponsor's last update on 26 Jun 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. 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.
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?
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?
Delta Bishop score (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT06550232, which also lists 6 linked publications.
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 26 Jun 2025.