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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01428375
Other study ID # PARACETAMOL-INTRAPARTUM
Secondary ID PARACETAMOL-INTR
Status Completed
Phase Phase 3
First received August 15, 2011
Last updated February 4, 2013
Start date August 2011
Est. completion date October 2012

Study information

Verified date February 2013
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ain Shams College of Medicine Research and Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Ain Shams Maternity Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process. 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. No
Secondary To document safety By assessing the adverse events recorded during the study either maternal or fetal/neonatal. Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours. Yes
Secondary To correlate with the duration of labor The difference between both groups regarding labour duration 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. No
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