NCT05097950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

September 12, 2021

Last Update Submit

January 8, 2025

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • need for additional analgesic agent

    through study completion, an average of 1 year

  • maternal mobility

    through study completion, an average of 1 year

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Administration of 1 gr paracetamol I.V

Drug: Administration of 1 gr paracetamol I.V

Control Group

PLACEBO COMPARATOR

Administration of 100 ml. sodium chloride 0.9% IV

Drug: Administration of 1 gr paracetamol I.V

Interventions

Administration of 1 gr paracetamol I.VDRUG

Administration of 1 gr paracetamol I.V

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inshirah Sgayer

Nahariya, 2210001, Israel

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
inshirah sgayer

Study Record Dates

First Submitted

September 12, 2021

First Posted

October 28, 2021

Study Start

September 2, 2021

Primary Completion

January 9, 2023

Study Completion

January 16, 2023

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

IL(1)