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

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759364
• Other study ID #: 0012-23-NHR
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: June 2023
• Source: Western Galilee Hospital-Nahariya
• Contact: Raneen Abu Shqara, MD
• Phone: +972549793591
• Email: rabushqara[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Delivery Delayed
• Induction of Labor
• Labor Pain
• Pain, Acute

Intervention

Drug:
• IV Papaverine 80 mg
Opium alkaloid antispasmodic drug
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Galilee Medical Center	Nahariya	Hazafon

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Ibrahim MI, Alzeeniny HA, Ellaithy MI, Salama AH, Abdellatif MA. Drotaverine to improve progression of labor among nulliparous women. Int J Gynaecol Obstet. 2014 Feb;124(2):112-7. doi: 10.1016/j.ijgo.2013.08.013. Epub 2013 Nov 7. — View Citation

Madhu C, Mahavarkar S, Bhave S. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour. Arch Gynecol Obstet. 2010 Jul;282(1):11-5. doi: 10.1007/s00404-009-1188-8. Epub 2009 Jul 31. — View Citation

Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD009243. doi: 10.1002/14651858.CD009243.pub2. — View Citation

Singh KC, Jain P, Goel N, Saxena A. Drotaverine hydrochloride for augmentation of labor. Int J Gynaecol Obstet. 2004 Jan;84(1):17-22. doi: 10.1016/s0020-7292(03)00276-5. — View Citation

Snir N, Moskovitz B, Nativ O, Margel D, Sandovski U, Sulkes J, Livne PM, Lifshitz DA. Papaverine hydrochloride for the treatment of renal colic: an old drug revisited. A prospective, randomized study. J Urol. 2008 Apr;179(4):1411-4. doi: 10.1016/j.juro.2007.11.053. Epub 2008 Mar 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The delta Bishop score	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	1 year
Primary	Pain during insertion of the catheter	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	1 year
Secondary	Induction-delivery interval	Time from insertion of the catheter balloon to delivery. Longer interval means worse outcome	2 years
Secondary	Success	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	2 years
Secondary	Use of other ripening method	The need for other ripening method due to low bishop score (<6) after extraction of the catheter balloon	2 years
Secondary	Insertion-extraction of the catheter interval	Time between insertion to extraction of the catheter balloon.	2 years
Secondary	Delivery method	Cesarean or vaginal delivery	2 years
Secondary	Maternal satisfaction	Based on visual scale analoug score for satisfaction (1-5), the minimum is 1, the maximum is 5, higher score means better outcome	1 year
Secondary	Apgar Score	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.	2 years
Secondary	Cord pH	Cord blood gas analysis is an objective measure of the fetal metabolic condition at the time of delivery	2 years
Secondary	Need for neonatal intensive case admission	Is a measure of neonatal complications at birth	2 years