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:
Participant gender:
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.