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

NCT ID: NCT05759364

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-04-01

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.

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

IV Papaverine 80 mg

Intervention Type: DRUG

Opium alkaloid antispasmodic drug

Conrol group- Placebo group.

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

IV Papaverine 80 mg

Opium alkaloid antispasmodic drug

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Papaverine Hydrochloride; Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Maya Wolf

Director of Maternal-fetal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maya Frank Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Galilee Medical Center

Locations

Galilee Medical Center

Nahariya, Northern District, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Raneen Abu Shqara, MD

Role: CONTACT

rabushqara@gmail.com

+972549793591

Maya Frank Wolf, MD

Role: CONTACT

mayaw@gmc.gov.il

+972507887800

Facility Contacts

Amal Shahen

Role: primary

amals@gmc.gov.il

References

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

Reference Type: BACKGROUND

PMID: 22895986 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14698825 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24299975 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19644697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18289563 (View on PubMed)

Abu Shqara R, Nakhleh Francis Y, Goldinfeld G, Haddad Y, Sgayer I, Lavinsky M, Lowenstein L, Frank Wolf M. Papaverine prior to catheter balloon insertion for labor induction: a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jul;6(7):101388. doi: 10.1016/j.ajogmf.2024.101388. Epub 2024 May 31.

Reference Type: DERIVED

PMID: 38825005 (View on PubMed)

Other Identifiers

0012-23-NHR

Identifier Type: -

Identifier Source: org_study_id