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

Sponsor

Western Galilee Hospital-Nahariya (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05759364

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The cervix consists of connective tissue, smooth muscle, and parasympathetic innervation. Smooth muscle makes up about 15% of the cervix, is mainly found under the internal opening of the neck. Papaverine and its derivatives are musculotropic antispasmodic drugs that directly affect smooth muscle, the mechanism is to reduce the spasm of smooth muscle resulting in relaxation. Studies on the pharmacokinetics of this drug show that it has a half-life of 0.5-2 hours and its effect is apparent within 10 minutes.

Administration of antispasmodic drugs during childbirth is common in developing and developed countries. Based on previous studies, the use of these drugs during childbirth may lead to a faster opening of the cervix. Possible uses of Papaverine include, administered separately or in combination with other treatments such as rupture of amniotic membranes and/or Oxytocin administration. According to some studies, administration of Papaverine at birth can be used as a preventive or therapeutic strategy in cases of prolonged labor or first stage over 12 hours as defined in some studies. According to Kochran et al, who included 13 experiments with 1995 participants, the use of antispasmodic drugs shortened the first stage of labor by an average of 74.34 minutes. In 6 experiments that included 820 patients, the administration of antispasmodic drugs during labor increases the rate of cervical opening by an average of 0.61 cm per hour.

In addition to the muscle relaxation effect, studies have been published on the analgesic effect of PAPAVERINE for example in patients with urinary stones.

In the present study, the investigators want to test the effect of administering PAPAVERINE IV 80 mg within half an hour before the insertion of a catheter balloon for cervical ripening on the Bishop score after catheter removal between the two groups.

Condition or Disease	Intervention/Treatment	Phase
Induction of Labor Pain, Acute Labor Pain Delivery Delayed	Drug: IV Papaverine 80 mg Drug: Placebo	N/A

Detailed Description

There are different methods of induction of labor, the choice of the best method for that patient depends on the bishop score, an estimate that is based on data related to the cervix such as opening, effacement and other parameters, also the choice of the method of induction depends on the obstetric history of the patient. A Bishop score less than 6 indicates an unriped cervix, therefore increasing the chance of labor induction failure,methods have been developed to ripen the cervix; among the methods are catheter balloon insertion and prostaglandins. The mechanisms by which the catheter works include a mechanical effect and indirect effect on local secretion of prostaglandins.

In addition to the muscle relaxation effect, studies have been published on the analgesic effect of PAPAVERINE for example in patients with urinary stones.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blinded randomized placebo controlled trial Group 1: will get IV PAPAVERINE 80 mg in 100 ml saline Group 2: will get IV 100 ml salineDouble blinded randomized placebo controlled trial Group 1: will get IV PAPAVERINE 80 mg in 100 ml saline Group 2: will get IV 100 ml saline

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The participant will be blinded to the type of therapy they recieved. Inverstiagators will be blinded. Outcome assessor, including the physican that will assess the bishop score will be blinded Only the nurse that gives the therapy won't be blinded.

Primary Purpose:

Treatment

Official Title:

The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain, Double Blinded Randomized Placebo Controlled Trial

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention group- IV PAPAVERINE 80 mg Administration of IV PAPAVERINE 80 mg in 100 ml of saline, once within half an hour before inserting a single-balloon balloon catheter	Drug: IV Papaverine 80 mg Opium alkaloid antispasmodic drug Other Names: Papaverine Hydrochloride
Placebo Comparator: Conrol group- Placebo group. Administration of 100 ml of saline within half an hour before the insertion of a single-balloon catheter	Drug: Placebo Placebo Other Names: Saline

Arm

Intervention/Treatment

Active Comparator: Intervention group- IV PAPAVERINE 80 mg

Administration of IV PAPAVERINE 80 mg in 100 ml of saline, once within half an hour before inserting a single-balloon balloon catheter

Drug: IV Papaverine 80 mg

Opium alkaloid antispasmodic drug

Other Names:

Papaverine Hydrochloride

Placebo Comparator: Conrol group- Placebo group.

Administration of 100 ml of saline within half an hour before the insertion of a single-balloon catheter

Drug: Placebo

Placebo

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

The delta Bishop score [1 year]
The difference between the bishop score (a score of the cervix ripening) before and after the insertion of Foley catheter. Higher delta Bishop scores means better outcome
Pain during insertion of the catheter [1 year]
Pain during insertion of the catheter based on visual scale analoug (0-10) score, . The minimum is 0, the maximum is 10. Higher score means worse outcome

Secondary Outcome Measures

Induction-delivery interval [2 years]
Time from insertion of the catheter balloon to delivery. Longer interval means worse outcome
Success [2 years]
Bishop score (a score of cervix ripenining) after extraction of the catheter above or equal to 8. Bishop score above or equal to 8, means better outcome
Use of other ripening method [2 years]
The need for other ripening method due to low bishop score (<6) after extraction of the catheter balloon
Insertion-extraction of the catheter interval [2 years]
Time between insertion to extraction of the catheter balloon.
Delivery method [2 years]
Cesarean or vaginal delivery
Maternal satisfaction [1 year]
Based on visual scale analoug score for satisfaction (1-5), the minimum is 1, the maximum is 5, higher score means better outcome
Apgar Score [2 years]
The Apgar score, is a score given to the newborn in 1,5 and 10 minutes after birth, and is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
Cord pH [2 years]
Cord blood gas analysis is an objective measure of the fetal metabolic condition at the time of delivery
Need for neonatal intensive case admission [2 years]
Is a measure of neonatal complications at birth

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with a singleton pregnancy, over the age of 18, pregnant at term (ie between weeks 37-42)
Bishop score is less than 6, for which a medical decision was made regarding the induction of labor by catheter
Vertex presentation, intact membranes
Viable fetus