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Completed

NCT Number: NCT05097950

Labor Induction and Pain Relief With Paracetamol Versus Placebo

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.

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Key information

Conditions

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

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inshirah Sgayer

Nahariya, 2210001, Israel

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Sensitivity to paracetamol.
  • Past Cesarean section
  • Multiple pregnancy

Treatment and study plan

Administration of 1 gr paracetamol I.V

Drug

Administration of 1 gr paracetamol I.V

Primary outcomes

  1. PAIN assessment during catheter balloon insertion

    Time frame: 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

  2. maternal satisfaction

    Time frame: through study completion, an average of 1 year

    maternal satisfaction will be evaluated using a questionnaire

Secondary outcomes

  1. need for additional analgesic agent

    Time frame: through study completion, an average of 1 year

    need for additional analgesic agent than paracetamol after catheter balloon insertion

  2. maternal mobility

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2021
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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