Premature Rupture of MembranesPhase 4NCT07517796
I.V Papavrine for Labor Induction in Term PROM
A Phase 4 study testing Papaverine arm in people with Premature Rupture of Membranes, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. 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
- Premature Rupture of Membranes
- What is being tested?
- Papaverine arm
- 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
- 22 Oct 2025to 22 Oct 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Singleton pregnancy
- Term gestation (37-42 weeks)
- Term PROM prior to active labor
- Duration of PROM <12 hours at enrollment
- Bishop score <8
- Cephalic presentation
- Viable fetus with reassuring fetal heart rate
Who cannot join
- • Multiple gestation
- Previous cesarean delivery
- Major fetal anomalies
- Contraindication to vaginal delivery
- Meconium-stained amniotic fluid
- Suspected chorioamnionitis
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
Galilee Medical Center
Nahariya, Israel
Maya Frank Wolf, professor, +972507887800, mayaw@gmc.gov.il
About this study
Official title: I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo
Read the detailed description
Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.
- Conditions
- Premature Rupture of Membranes
- Being tested
- Papaverine arm, Placebo
- Keywords
- premature rupture of membranes, papaverine, bishop score
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papaverine armDrug
given 12 houres after rupture of membranes
PlaceboOther
I.V seline
| Study group | Role | What they receive |
|---|---|---|
| papaverine arm | Active comparator | IV-papaverine 80 mg in 100 ml 0.9% saline, once, 12 hours after rupture of membranes Receives: Drug: Papaverine arm |
| Control arm | Placebo comparator | I.V 100 ml 0.9% saline, 12 hours after rupture of membranes Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval from rupture of membranes to delivery
Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods
Measured: up to 5 days from rupture of membranes
Secondary outcomes (2)
change in bishop score following intervention
Bishop score messured at admission and 18 houres after rupture of membranes, and comparing the delta bishop scores between the groups
Measured: baseline to 6-12 hours after intervention
mode of delivary
Mode of delivery categorized as vaginal (spontaneous or operative) or cesarean delivery
Measured: At delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start22 Oct 2025
- Primary completion22 Oct 2027 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembranesStudies 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 (estimated)
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
- NCT07517796
- Sponsor's protocol ID
- 0152-25-NHR
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I.V Papavrine for Labor Induction in Term PROM: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07517796
- Acronym / sponsor ID
- 0152-25-NHR
- Conditions
- Premature Rupture of Membranes
- Keywords
- premature rupture of membranes, papaverine, bishop score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 8 Apr 2026 (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 controlled trial aims to evaluate whether intravenous administration of papaverine 12 hours after term PROM reduces the interval from membrane rupture to delivery and improves maternal and neonatal outcomes. Researchers will compare drug papaverine to a placebo
Detailed description
Prelabor rupture of membranes (PROM) at term complicates approximately 8% of pregnancies and is associated with increasing maternal and neonatal infectious morbidity as the latency period to delivery lengthens. Consequently, most clinical guidelines recommend active management with labor induction within 24 hours following membrane rupture. Cervical status at the time of induction plays a critical role in labor outcomes, and women with an unfavorable cervix, commonly defined as a Bishop score below 8, are at increased risk of prolonged labor and induction failure. The uterine cervix is composed primarily of connective tissue, with smooth muscle accounting for approximately 15% of its structure and concentrated mainly beneath the internal cervical os. Papaverine is a musculotropic antispasmodic agent that acts directly on smooth muscle, leading to reduced muscle spasm and enhanced relaxation. The pharmacokinetic profile of papaverine includes a rapid onset of action within approximately 10 minutes and a short half-life of 0.5-2 hours, making it a potentially suitable adjunct during early labor. Antispasmodic agents have been shown to accelerate cervical dilatation and shorten the first stage of labor; however, their role in the management of term PROM has not been systematically evaluated. We therefore aim to investigate whether intravenous administration of papaverine in women with term PROM shortens the interval from membrane rupture to delivery and improves cervical ripening and maternal and neonatal outcomes.
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: Papaverine armIV-papaverine 80 mg in 100 ml 0.9% saline, once, 12 hours after rupture of membranes |
| Control arm | Placebo comparator | Other: PlaceboI.V 100 ml 0.9% saline, 12 hours after rupture of membranes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Singleton pregnancy
Key exclusion criteria (6 listed)
- • Multiple gestation
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 armgiven 12 houres after rupture of membranes | Drug | papaverine arm |
| PlaceboI.V seline | Other | Control arm |
Primary outcome
Time interval from rupture of membranes to delivery
Time frame: up to 5 days from rupture of membranes
Time from rupture of membrane to delivery, measured in hours, including pre and post intervention periods
2 secondary outcomes
change in bishop score following intervention
Time frame: baseline to 6-12 hours after intervention
mode of delivary
Time frame: At delivery/birth
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 8 Apr 2026.
- 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.
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 arm in people with Premature Rupture of Membranes, 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 7 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 8 Apr 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.
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 Maya Frank Wolf, professor (• 972:50-7887800, mayaw@gmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval from rupture of membranes to delivery (time frame: up to 5 days from rupture of membranes). 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 8 Apr 2026.