IV PAPAVERINE Prior to Propess for Labor Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2025-03-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain

NCT05759364

Induction of Labor Pain, Acute Labor Pain +1 more

UNKNOWN NA

Use of Papaverine to Shorten the Second Stage/Duration of Labor in Pregnant Women After Cervical Ripening by Double-balloon Catheter

NCT07237880

Labor, Induced

RECRUITING NA

Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction

NCT06547437

Induced; Birth Labor Onset and Length Abnormalities

NOT_YET_RECRUITING NA

The Impact of Papaverine on First Stage of Labor

NCT02362139

Duration of Labor.

UNKNOWN PHASE3

Labor Induction and Pain Relief With Paracetamol Versus Placebo

NCT05097950

Labor Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Induced Vaginal Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The group allocation will be double blind. The randomization table will be available only to one member of the study, who will prepare the medications according to the allocated intervention. Participants will receive intravenous 0.9% normal saline with or without papaverine. The same bottles of normal saline will be use for the papaverine and placebo groups. Accordingly, the participants will be masked for the intervention. The participants, the researchers including the obstetricians who inserted the PGE2 (propess), the caregiver nurse who administrated the medication, the data collector, and the statistician will be blinded to the group allocations throughout the study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

papaverine arm

IV-papaverine 80 mg in 100 ml 0.9% saline, once

Group Type ACTIVE_COMPARATOR

Papaverine

Intervention Type DRUG

Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline

Control arm

I.V 100 ml 0.9% saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

I.V Sallne

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Papaverine

Within 30-minutes prior to catheter insertion, women in the intervention group will receive IV-papaverine 80 mg in 100 ml 0.9% saline

Intervention Type DRUG

placebo

I.V Sallne

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* singleton term pregnancy
* bishop score
* need for labor induction with PGE2
* vertex presentation
* viable fetus

Exclusion Criteria

* Prelabour rupture of membrane
* Twins pregnancy
* previous cesarean section
* allergy to the study medication
* fetal anomaly contraindications for vaginal delivery
* maternal supraventricular tachicardia

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes