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 Title of Study: “Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: October 2012
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.
- Drug: (1) Paracetamol injection
- Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion
- Other: Sterile water
- Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion
Arms, Groups and Cohorts
- Active Comparator: (1) Active (Paracetamol) arm: n=60
- Placebo Comparator: (2) Placbo (Sterile water) arm: n=60
- Sterile water
Clinical Trial Outcome Measures
- To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
- Time Frame: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours.
- By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.
- To document safety
- Time Frame: Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.
- By assessing the adverse events recorded during the study either maternal or fetal/neonatal.
- To correlate with the duration of labor
- Time Frame: Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours.
- The difference between both groups regarding labour duration
Participating in This Clinical Trial
1. Age between 18-35 years.
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).
1. Extreme of age (below 18-above 35).
3. Multiple gestation.
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.
15. Pre-mature rupture of membranes.
16. Intra uterine infections.
17. Hypersensitivity to paracetamol.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Ain Shams University
- Provider of Information About this Clinical Study
- Principal Investigator: Ahmed Elsayed Hassan Elbohoty, Lecturer in OB GYN – Ain Shams University
- Overall Official(s)
- Ahmed E Elbohoty, MD, Principal Investigator, OB GYN Department, faculty of Medicine, ASU
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