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

NCT05759364 | Unknown DMC

• 1 other identifier: 0012-23-NHR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Induction of labor; Ripenning of the cervix; Catheter balloon; Antispasmodic

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Induction-delivery interval

  2 years

• Success

  2 years

• Use of other ripening method

  2 years

• Insertion-extraction of the catheter interval

  2 years

• Delivery method

  2 years

Study Arms (2)

Intervention group- IV PAPAVERINE 80 mg

ACTIVE COMPARATOR

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

Conrol group- Placebo group.

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

IV Papaverine 80 mg DRUG

Opium alkaloid antispasmodic drug

Also known as: Papaverine Hydrochloride

Intervention group- IV PAPAVERINE 80 mg

Placebo DRUG

Placebo

Also known as: Saline

Conrol group- Placebo group.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Obstetrical research
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galilee Medical Center

Nahariya, Northern District, Israel

RECRUITING

Related Publications (6)

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

  PMID: 22895986 BACKGROUND

• 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.

  PMID: 14698825 BACKGROUND

• 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.

  PMID: 24299975 BACKGROUND

• 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.

  PMID: 19644697 BACKGROUND

• 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.

  PMID: 18289563 BACKGROUND

• 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.

  PMID: 38825005 DERIVED

MeSH Terms

Conditions

Acute Pain; Labor Pain

Interventions

Papaverine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maya Frank Wolf, MD

  Galilee Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raneen Abu Shqara, MD

CONTACT

+972549793591; rabushqara@gmail.com

Maya Frank Wolf, MD

CONTACT

+972507887800; mayaw@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Maternal-fetal medicine

Model Details: 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 saline

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 8, 2023
• Study Start: May 15, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)