Oral Paracetamol as Preemptive Analgesia for Labor Pain

Labor Pain Clinical Trial

Official title:

Oral Paracetamol as Preemptive Analgesia for Labor Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817829
• Other study ID #: OPPALP
• Secondary ID: Personal
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2013
• Last updated: March 21, 2013
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

Description:

It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• primigravida

• The gestational age between 37- 42 weeks

• Not seeking analgesia

• Singleton pregnancy

• vertex

• Spontaneous onset of labour

• 1st stage of labour (less than 5 cm)

Exclusion Criteria:

• Extreme of age (below18-above 40)

• Multiparous

• Multiple gestation

• Malpresentation

• Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)

• Any medical disorder with pregnancy

• Induction of labour

• Advanced 1st stage > 5 cm

• Use of any other kind of analgesia before recruitment in the study

• Scared uterus

• Fetal distress

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

• Labor Pain

Intervention

Drug:
• paracetamol
500 mg oral tablet
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	To document the efficacy of oral paracetamol, in pregnant women in labor, as demonstrated by the degree of pain relief and need for additional analgesia during the labor process and the early postpartum period.	intrapartum	No
Secondary	Safety	To document safety and evaluate adverse events recorded during the study either maternal or fetal.	Start of medication till 24 hours postpartum	Yes
Secondary	Duration of labor	To assess the effect of the duration of labor.	Start of medication till delivery of fetus.	No