Labor Induction and Pain Relief With Paracetamol Versus Placebo

Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter

Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Administration of 1 gr paracetamol I.V

Detailed Description

Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.

assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.

An assessment of pain management will also be conducted using various assessment tools:

1. Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.
2. Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.
3. Patient Experience Questionnaire - upon transfer to delivery room.
4. Socio-demographic Questionnaire

Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 2210001
    • Inshirah Sgayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity

Exclusion Criteria:

1. Sensitivity to paracetamol.
2. Past Cesarean section
3. Multiple pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; Administration of 1 gr paracetamol I.V	Drug: Administration of 1 gr paracetamol I.V; Administration of 1 gr paracetamol I.V
Placebo Comparator: Control Group; Administration of 100 ml. sodium chloride 0.9% IV	Drug: Administration of 1 gr paracetamol I.V; Administration of 1 gr paracetamol I.V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAIN assessment during catheter balloon insertion	pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10	through study completion, an average of 1 year
maternal satisfaction	maternal satisfaction will be evaluated using a questionnaire	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for additional analgesic agent	need for additional analgesic agent than paracetamol after catheter balloon insertion	through study completion, an average of 1 year
maternal mobility	women were asked through a questionnaire about whether they were immoblile after the catheter insetion using a score from 0 to 10	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: October 17, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Acetaminophen
• Other Study ID Numbers: 0065-21-NHR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No