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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02578251
Other study ID # IP-PCM
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received October 15, 2015
Last updated October 15, 2015
Start date October 2015
Est. completion date March 2016

Study information

Verified date October 2015
Source Ain Shams Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial Summary

The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 104
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria:

- Primiparity

- Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)

- Maternal age between 20-30 years

- Singleton term pregnancy (37-42 weeks of gestation)

- Vertex-presenting fetus

Exclusion Criteria:

- Clinical evidence of cephalopelvic disproportion

- Scarred uterus; previous cesarean section, hysterotomy or myomectomy

- Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment

- Fetal distress

- Receiving any regional or parenteral analgesia before recruitment in the study

- Known hypersensitivity to the drug family

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Paracetamol

Pethidine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams Maternity Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale. Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain]. 4 hours Yes
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