Labor Induction and Pain Relief With Paracetamol Versus Placebo

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Drug: Administration of 1 gr paracetamol I.V

• Registration Number: NCT05097950
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

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.

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 Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-10-17
• Study First Posted: 2021-10-28
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Administration of 1 gr paracetamol I.V	Administration of 1 gr paracetamol I.V
Control Group	Administration of 1 gr paracetamol I.V	Administration of 100 ml. sodium chloride 0.9% IV

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inshirah Sgayer; 🇮🇱 Nahariya, Israel