Premature Rupture of Fetal MembranesNCT07826533
Intravenous Papaverine for Term Prelabor Rupture of Membranes
A study testing Papaverine in people with Premature Rupture of Fetal Membranes, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Rupture of Fetal Membranes
- 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
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Mar 2025to 21 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥18 years
- Gestational age ≥37 weeks with term PROM
- No active contractions
- Cervical dilation <2 cm
- Vertex presentation
- PROM duration between 2 and 12 hours
Who cannot join
- Previous cesarean delivery
- Contraindication to vaginal delivery
- Known fetal malformation
- Known allergy to papaverine
- Cardiac arrhythmia
- Glaucoma
Show all 13Show fewer
- Hepatitis or other hepatic disease
- Atrioventricular (AV) block
- Congestive heart disease
- Recent ischemic heart disease
- Increased intracranial pressure
- Active labor, defined as cervical dilation ≥6 cm
- Contraindication to uterine relaxation, including significant uterine bleeding or fetal distress Active infection or chorioamnionitis Use of medications with potentially hazardous interactions with papaverine
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
The Edith Wolfson Medical Center
Holon, 5822012
Eliel Kedar Sade, MD, +972-52-6008068, elielbob@gmaill.com
Ornit Cohen, +972-3-5028399, ornitc@wmc.gov.il
About this study
Official title: The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)
This randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.
Read the detailed description
Women hospitalized in the labor and delivery unit with term premature rupture of membranes at 37 weeks of gestation or later are screened for participation. Eligible participants have no active contractions, cervical dilation of less than 2 cm, vertex presentation, and a duration of membrane rupture between 2 and 12 hours.
Following informed consent, participants are randomized in a 1:1 ratio to receive intravenous papaverine 80 mg diluted in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo. The study infusion is administered one hour after initiation of oxytocin.
Treatment allocation is blinded. One study-team member prepares the study solution according to the randomization table, while the remainder of the study team remains blinded to treatment allocation. The primary outcome is the interval from study infusion to delivery.
- Conditions
- Premature Rupture of Fetal Membranes
- Being tested
- Papaverine, Normal Saline Placebo Infusion
- Keywords
- Term PROM, Premature rupture of membranes, Papaverine, Labor induction, Oxytocin
- 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.
PapaverineDrug
Papaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion.
Normal Saline Placebo InfusionDrug
Also called 0.9% Sodium Chloride
100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion.
| Study group | Role | What they receive |
|---|---|---|
| Papaverine | Experimental | Participants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline. Receives: Drug: Papaverine |
| Placebo | Placebo comparator | Participants received 100 mL of intravenous 0.9% normal saline as placebo. Receives: Drug: Normal Saline Placebo Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Study Infusion to Delivery
Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
Measured: From administration of the study infusion until delivery, assessed up to 48 hours
Secondary outcomes (6)
Mode of Delivery
Mode of delivery, categorized as vaginal or cesarean delivery
Measured: From rupture of membranes until delivery, assessed up to 48 hours
Maternal Infectious Complications
Proportion of participants with maternal infectious complications
Measured: From rupture of membranes until delivery, assessed up to 48 hours
Postpartum Hemorrhage
Proportion of participants with postpartum hemorrhage
Measured: From rupture of membranes until delivery, assessed up to 48 hours
Apgar Score at 5 Minutes
Apgar score recorded 5 minutes after birth, ranging from 0 to 10
Measured: 5 minutes after birth
Umbilical Cord pH Below 7.1
Proportion of neonates with umbilical cord blood pH below 7.1
Measured: At birth, based on umbilical artery cord blood sampling
Neonatal Infection
Proportion of neonates diagnosed with neonatal infection
Measured: From birth through neonatal hospital discharge, assessed up to 7 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start20 Mar 2025
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature Rupture of Fetal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to receive intravenous papaverine or placebo in two parallel groups.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826533
- Sponsor's protocol ID
- WOMC-0047-25
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
PubMed 32080050Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
PubMed 28050900Abu Shqara R, Nakhleh Francis Y, Goldinfeld G, Haddad Y, Sgayer I, Lavinsky M, Lowenstein L, Frank Wolf M. Papaverine prior to catheter balloon insertion for labor induction: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101388. doi: 10.1016/j.ajogmf.2024.101388. Epub 2024 May 31.
PubMed 38825005Singh 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 14698825Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
PubMed 23737030
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Papaverine on Labour in Term Premature Rupture of Membranes (PROM)
- ClinicalTrials.gov ID
- NCT07826533
- Acronym / sponsor ID
- WOMC-0047-25
- Conditions
- Premature Rupture of Fetal Membranes
- Keywords
- Term PROM, Premature rupture of membranes, Papaverine, Labor induction, Oxytocin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 21 Apr 2027 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 17 Sep 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 randomized, double-blind, placebo-controlled trial evaluates whether intravenous papaverine, administered as an adjunct to oxytocin, shortens the time to delivery in women with term premature rupture of membranes (PROM). Participants are randomized in a 1:1 ratio to receive either intravenous papaverine 80 mg in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo, administered one hour after initiation of oxytocin. The primary outcome is the interval from study infusion to delivery. Secondary outcomes include mode of delivery and maternal and neonatal outcomes.
Detailed description
Women hospitalized in the labor and delivery unit with term premature rupture of membranes at 37 weeks of gestation or later are screened for participation. Eligible participants have no active contractions, cervical dilation of less than 2 cm, vertex presentation, and a duration of membrane rupture between 2 and 12 hours.
Following informed consent, participants are randomized in a 1:1 ratio to receive intravenous papaverine 80 mg diluted in 100 mL of 0.9% saline or 100 mL of 0.9% saline as placebo. The study infusion is administered one hour after initiation of oxytocin.
Treatment allocation is blinded. One study-team member prepares the study solution according to the randomization table, while the remainder of the study team remains blinded to treatment allocation. The primary outcome is the interval from study infusion to delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive intravenous papaverine or placebo in two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Papaverine | Experimental | Drug: PapaverineParticipants received intravenous papaverine 80 mg diluted in 100 mL of 0.9% normal saline. |
| Placebo | Placebo comparator | Drug: Normal Saline Placebo InfusionParticipants received 100 mL of intravenous 0.9% normal saline as placebo. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Gestational age ≥37 weeks with term PROM
- No active contractions
- Cervical dilation <2 cm
- Vertex presentation
Key exclusion criteria (13 listed)
- Previous cesarean delivery
- Contraindication to vaginal delivery
- Known fetal malformation
- Known allergy to papaverine
- Cardiac arrhythmia
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 |
|---|---|---|
| PapaverinePapaverine 80 mg diluted in 100 mL of 0.9% normal saline, administered intravenously as a single study infusion. | Drug | Papaverine |
| Normal Saline Placebo InfusionAlso: 0.9% Sodium Chloride100 mL of 0.9% normal saline, administered intravenously as a single placebo study infusion. | Drug | Placebo |
Primary outcome
Time From Study Infusion to Delivery
Time frame: From administration of the study infusion until delivery, assessed up to 48 hours
Time, measured in hours, from administration of the assigned study infusion (papaverine or placebo) to delivery.
6 secondary outcomes
Mode of Delivery
Time frame: From rupture of membranes until delivery, assessed up to 48 hours
Maternal Infectious Complications
Time frame: From rupture of membranes until delivery, assessed up to 48 hours
Postpartum Hemorrhage
Time frame: From rupture of membranes until delivery, assessed up to 48 hours
Apgar Score at 5 Minutes
Time frame: 5 minutes after birth
Umbilical Cord pH Below 7.1
Time frame: At birth, based on umbilical artery cord blood sampling
Neonatal Infection
Time frame: From birth through neonatal hospital discharge, assessed up to 7 days after 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 17 Sep 2026.
- Background: PubMed 32080050Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
- Background: PubMed 28050900Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
- Background: PubMed 38825005Abu Shqara R, Nakhleh Francis Y, Goldinfeld G, Haddad Y, Sgayer I, Lavinsky M, Lowenstein L, Frank Wolf M. Papaverine prior to catheter balloon insertion for labor induction: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101388. doi: 10.1016/j.ajogmf.2024.101388. Epub 2024 May 31.
- 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 23737030Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.
- Individual participant dataSharing planned: No
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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 study testing Papaverine in people with Premature Rupture of Fetal Membranes, 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 13 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 17 Sep 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 Eliel Kedar Sade, MD (+972-52-6008068, elielbob@gmaill.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Study Infusion to Delivery (time frame: From administration of the study infusion until delivery, assessed up to 48 hours). 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 NCT07826533, which also lists 5 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 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.