Labor Induction and Pain Relief With Paracetamol Versus Placebo

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05097950
• Other study ID #: 0065-21-NHR
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Sensitivity to paracetamol.

2. Past Cesarean section

3. Multiple pregnancy

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Administration of 1 gr paracetamol I.V
Administration of 1 gr paracetamol I.V

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year
Primary	vaginal delivery rate	vaginal delivery rate in percents (%) will be assessed and compared in the two groups Rate of cesarean sections will be assessed	one year