Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.

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Detailed Description

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Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.

Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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(1) Active (Paracetamol) arm: n=60

(Paracetamol)

Group Type ACTIVE_COMPARATOR

(1) Paracetamol injection

Intervention Type DRUG

Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion

(2) Placbo (Sterile water) arm: n=60

Sterile water

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type OTHER

Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion

Interventions

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(1) Paracetamol injection

Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion

Intervention Type DRUG

Sterile water

Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age between 18-35 years.
2. Primigravida.
3. The gestational age between 37- 42 weeks.
4. Patient seeking analgesia.
5. Single viable fetus.
6. Vertex presentation.
7. Spontaneous onset of labor.
8. 1st stage of labor with cervical dilatation 3-4 cm ( in active phase).

Exclusion Criteria

1. Extreme of age (below 18-above 35).
2. Multiparity.
3. Multiple gestation.
4. Malpresentation.
5. Major degree of cephalopelvic disproportion.
6. Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
7. Induction of labor.
8. Cervical dilatation exceeds exceeding 4 cm.
9. Use of any other kind of analgesia before recruitment in the study.
10. Scared uterus.
11. Fetal distress.
12. Antepartum hemorrhage.
13. Intrapartum bleeding.
14. Polyhydramnios.
15. Pre-mature rupture of membranes.
16. Intra uterine infections.
17. Hypersensitivity to paracetamol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No