Labor Induction and Pain Relief With Paracetamol Versus Placebo

Western Galilee Hospital-Nahariya

Status: Completed

Conditions: Labor Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05097950

0065-21-NHR

Details and patient eligibility

About

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.

Full 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%).

Enrollment: 141 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

141 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Description:

Administration of 1 gr paracetamol I.V

Treatment:

Drug: Administration of 1 gr paracetamol I.V

Control Group

Placebo Comparator group

Description:

Administration of 100 ml. sodium chloride 0.9% IV

Treatment:

Drug: Administration of 1 gr paracetamol I.V