Labor Induction and Pain Relief With Paracetamol Versus Placebo

NCT ID: NCT05097950

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-02

Study Completion Date

2023-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

Administration of 1 gr paracetamol I.V

Group Type ACTIVE_COMPARATOR

Administration of 1 gr paracetamol I.V

Intervention Type DRUG

Administration of 1 gr paracetamol I.V

Control Group

Administration of 100 ml. sodium chloride 0.9% IV

Group Type PLACEBO_COMPARATOR

Administration of 1 gr paracetamol I.V

Intervention Type DRUG

Administration of 1 gr paracetamol I.V

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Administration of 1 gr paracetamol I.V

Administration of 1 gr paracetamol I.V

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Inshirah Sgayer

inshirah sgayer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inshirah Sgayer

Nahariya, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0065-21-NHR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Drotaverine to Shorten the Length of Labor
NCT01639027 COMPLETED PHASE2/PHASE3