Induced; BirthNCT06547437
Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction
A study testing Papaverine and normal saline in people with Induced; Birth and Labor Onset and Length Abnormalities, run by Western Galilee Hospital-Nahariya.
Trial summary
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone 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
- Induced; Birth, Labor Onset and Length Abnormalities
- What is being tested?
- Papaverine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2025
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a singleton pregnancy Over the age of 18 Term (between 37-42 weeks of gestation) A medical decision for labor induction using oxytocin. Cephalic presentation Viable fetus nulliparity
Who cannot join
- parity >1
- Twin pregnancy Women with a previous cesarean section Severe fetal anomalies Women with psychiatric disorders, including depression and schizophrenia. Contraindication to vaginal delivery Women unable to sign the consent form Women known to have SVT (supraventricular tachycardia). Women with a heart rate over 100 or arrhythmia Known sensitivity to any component of the drug Liver disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: "Evaluating the Effectiveness of Papaverine as an Adjunct to Oxytocin for Labor Induction: A Randomized Controlled Trial"
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone
Read the detailed description
Labor induction is a common obstetric procedure aimed at stimulating uterine contractions to initiate labor, often due to medical or obstetric indications such as post-term pregnancy, preeclampsia, or fetal growth restriction. The primary objective is to achieve vaginal delivery while minimizing risks to both mother and child. Oxytocin, a synthetic analog of the natural hormone, is the most frequently used pharmacological agent for labor induction due to its effectiveness in promoting uterine contractions. However, its use is associated with complications, including uterine hyperstimulation, increased need for epidural analgesia, and higher rates of operative deliveries.
The potential of antispasmodics to aid in labor induction has been explored, with some studies indicating that these agents can reduce the duration of labor and enhance cervical dilation. The Cochrane review on antispasmodics for labor highlighted that these drugs, such as hyoscine butylbromide and drotaverine, could significantly reduce the duration of the first stage of labor and increase the rate of cervical dilation, although the overall quality of evidence was low. Despite these findings, further high-quality studies are recommended to substantiate these benefits and ensure safety.
Papaverine, a well-known smooth muscle relaxant traditionally used for treating vascular spasms, presents a promising adjunctive therapy for labor induction. By relaxing the smooth muscles of the cervix and uterus, papaverine may facilitate more efficient cervical ripening and enhance the effectiveness of oxytocin-induced contractions. Preliminary studies with other antispasmodics, such as butylscopolamine, have shown reductions in labor duration and improvements in labor progression without significant adverse effects, suggesting that papaverine might offer similar benefits.
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone. The primary outcome will be the time to onset of active labor, with secondary outcomes including total duration of labor, rate of cesarean deliveries, maternal satisfaction, and adverse effects. By investigating this novel combination, the study seeks to provide new insights into optimizing labor induction protocols, ultimately improving maternal and neonatal outcomes.
Objective: To evaluate if adding papaverine to oxytocin reduces the time to active labor compared to oxytocin alone.
Design: a randomized controlled study Participants: Pregnant women at term requiring labor induction using oxytocin. Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin.
Control Group: Oxytocin plus 100 mL saline.
Primary outcome: Time to onset of active labor. Secondary outcomes: Total duration of labor, length of first stage of labor, length of second stage of labor, rate of cesarean deliveries, rate of cervical dilation.
- Being tested
- Papaverine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapaverineDrug
papaverine a smooth muscle relaxant
normal salineDrug
Also called normal saline 0.9% 100 cc
normal saline 0.9% 100 cc
| Study group | Role | What they receive |
|---|---|---|
| oxytocin plus papaverine | Active comparator | Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin. Receives: Drug: Papaverine |
| oxytocin alone | Placebo comparator | Control Group: Oxytocin plus 100 mL saline. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to active delivery
time from labor induction till dilatation of 6 cm
Measured: 24 HOURS AFTER DELIVERY
Secondary outcomes (4)
vaginal deliveries in 24 hours
rate of vaginal deliveries in 24 hours
Measured: 24 HOURS AFTER DELIVERY
total length of labor
time for induction to delivery
Measured: 24 HOURS AFTER DELIVERY
cesarean delivery rate
rate of emergent cesarean delivery during labor
Measured: ho24 HOURS AFTER DELIVERY
length of second stage of labor
second stage of labor in hours
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced; BirthStudies 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
- Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin. Control Group: Oxytocin plus 100 mL saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Inshirah Sgayer, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547437
- Sponsor's protocol ID
- 0124-24-NHR
- Status last verified
- Sep 2024
- First submitted
- 1 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluating the Effectiveness of Papaverine as an Adjunct to Oxytocin for Labor Induction: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06547437
- Acronym / sponsor ID
- 0124-24-NHR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 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.
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone
Detailed description
Labor induction is a common obstetric procedure aimed at stimulating uterine contractions to initiate labor, often due to medical or obstetric indications such as post-term pregnancy, preeclampsia, or fetal growth restriction. The primary objective is to achieve vaginal delivery while minimizing risks to both mother and child. Oxytocin, a synthetic analog of the natural hormone, is the most frequently used pharmacological agent for labor induction due to its effectiveness in promoting uterine contractions. However, its use is associated with complications, including uterine hyperstimulation, increased need for epidural analgesia, and higher rates of operative deliveries.
The potential of antispasmodics to aid in labor induction has been explored, with some studies indicating that these agents can reduce the duration of labor and enhance cervical dilation. The Cochrane review on antispasmodics for labor highlighted that these drugs, such as hyoscine butylbromide and drotaverine, could significantly reduce the duration of the first stage of labor and increase the rate of cervical dilation, although the overall quality of evidence was low. Despite these findings, further high-quality studies are recommended to substantiate these benefits and ensure safety.
Papaverine, a well-known smooth muscle relaxant traditionally used for treating vascular spasms, presents a promising adjunctive therapy for labor induction. By relaxing the smooth muscles of the cervix and uterus, papaverine may facilitate more efficient cervical ripening and enhance the effectiveness of oxytocin-induced contractions. Preliminary studies with other antispasmodics, such as butylscopolamine, have shown reductions in labor duration and improvements in labor progression without significant adverse effects, suggesting that papaverine might offer similar benefits.
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone. The primary outcome will be the time to onset of active labor, with secondary outcomes including total duration of labor, rate of cesarean deliveries, maternal satisfaction, and adverse effects. By investigating this novel combination, the study seeks to provide new insights into optimizing labor induction protocols, ultimately improving maternal and neonatal outcomes.
Objective: To evaluate if adding papaverine to oxytocin reduces the time to active labor compared to oxytocin alone.
Design: a randomized controlled study Participants: Pregnant women at term requiring labor induction using oxytocin. Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin.
Control Group: Oxytocin plus 100 mL saline.
Primary outcome: Time to onset of active labor. Secondary outcomes: Total duration of labor, length of first stage of labor, length of second stage of labor, rate of cesarean deliveries, rate of cervical dilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin. Control Group: Oxytocin plus 100 mL saline.
| Arm | Type | Receives |
|---|---|---|
| oxytocin plus papaverine | Active comparator | Drug: PapaverineIntervention Group: Combined use of papaverine (80 mg intravenous mg in 100 mL saline once concurrent with the start of oxytocin) and oxytocin. |
| oxytocin alone | Placebo comparator | Drug: normal salineControl Group: Oxytocin plus 100 mL saline. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with a singleton pregnancy Over the age of 18 Term (between 37-42 weeks of gestation) A medical decision for labor induction using oxytocin. Cephalic presentation Viable fetus nulliparity
Key exclusion criteria (2 listed)
- parity >1
- Twin pregnancy Women with a previous cesarean section Severe fetal anomalies Women with psychiatric disorders, including depression and schizophrenia. Contraindication to vaginal delivery Women unable to sign the consent form Women known to have SVT (supraventricular tachycardia). Women with a heart rate over 100 or arrhythmia Known sensitivity to any component of the drug Liver disease
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 a smooth muscle relaxant | Drug | oxytocin plus papaverine |
| normal salineAlso: normal saline 0.9% 100 ccnormal saline 0.9% 100 cc | Drug | oxytocin alone |
Primary outcome
time to active delivery
Time frame: 24 HOURS AFTER DELIVERY
time from labor induction till dilatation of 6 cm
4 secondary outcomes
vaginal deliveries in 24 hours
Time frame: 24 HOURS AFTER DELIVERY
total length of labor
Time frame: 24 HOURS AFTER DELIVERY
cesarean delivery rate
Time frame: ho24 HOURS AFTER DELIVERY
length of second stage of labor
Time frame: 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Papaverine and normal saline in people with Induced; Birth and Labor Onset and Length Abnormalities, run by Western Galilee Hospital-Nahariya.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact inshirah sgayer (0508890662, inshirah.sg.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to active delivery (time frame: 24 HOURS AFTER DELIVERY). 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 19 Sep 2024.