Oral Paracetamol as Preemptive Analgesia for Labor Pain

NCT ID: NCT01817829

Last Updated: 2013-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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paracetamol

paracetamol 2 tablets1000mg PO.

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

500 mg oral tablet

placebo

placebo 2 tablets containing Starch PO

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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paracetamol

500 mg oral tablet

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Elsayed Hassan Elbohoty

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Personal

Identifier Type: OTHER

Identifier Source: secondary_id

OPPALP

Identifier Type: -

Identifier Source: org_study_id

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