Labor Pain
Conditions
Brief summary
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.
Detailed description
It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.
Interventions
DRUGparacetamol
500 mg oral tablet
DRUGplacebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | intrapartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Start of medication till 24 hours postpartum | To document safety and evaluate adverse events recorded during the study either maternal or fetal. |
| Duration of labor | Start of medication till delivery of fetus. | To assess the effect of the duration of labor. |
Outcome results
None listed