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

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western Galilee Hospital-Nahariya
• Treatments: Papaverine

Criteria

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

Exclusion Criteria:

• Twin pregnancy

• Women after caesarean section

• Severe fetal anomalies

• Women with vaginismus or vulvodynia

• Women with psychiatric illnesses including depression and schizophrenia

• Contraindication for vaginal delivery

• A woman who is unable to sign a consent form

• Women are known for supraventricular tachycardia

• Women with tachycardia over 100 or arrhythmia

• Known sensitivity to one of the components of the drug

• Liver disease