Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Papaverine 80 mg IV, Placebo (Normal Saline).
- Who it may be relevant to
- Registry conditions: Labor, Induced. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Papaverine 80 mg IV
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. - Drug 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.
Primary outcome measures
- Time from study drug administration to complete cervical dilation [Time frame: From study drug administration to complete cervical dilation, up to 24 hours.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Hillel Yaffe Medical Center — Hadera
Identifiers
NCT: NCT07237880 · 0100-24-HYMC