Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Labor Pain

Treatments: Drug: (1) Paracetamol injection; Other: Sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT01428375

PARACETAMOL-INTRAPARTUM (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

(Paracetamol)

Treatment:

Drug: (1) Paracetamol injection

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

Placebo Comparator group

Description:

Sterile water

Treatment:

Other: Sterile water