NCT01428375

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

August 15, 2011

Last Update Submit

February 4, 2013

Conditions

Labor Pain

Keywords

intravenous paracetamolintrapartum analgesialabor painintrapartum pains

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • To document safety

    Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.

  • To correlate with the duration of labor

    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.

Study Arms (2)

(1) Active (Paracetamol) arm: n=60

ACTIVE COMPARATOR

(Paracetamol)

Drug: (1) Paracetamol injection

(2) Placbo (Sterile water) arm: n=60

PLACEBO COMPARATOR

Sterile water

Other: Sterile water

Interventions

(1) Paracetamol injectionDRUG

Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion

(1) Active (Paracetamol) arm: n=60
Sterile waterOTHER

Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion

(2) Placbo (Sterile water) arm: n=60

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-35 years.
  • Primigravida.
  • The gestational age between 37- 42 weeks.
  • Patient seeking analgesia.
  • Single viable fetus.
  • Vertex presentation.
  • Spontaneous onset of labor.
  • st stage of labor with cervical dilatation 3-4 cm ( in active phase).

You may not qualify if:

  • Extreme of age (below 18-above 35).
  • Multiparity.
  • Multiple gestation.
  • Malpresentation.
  • Major degree of cephalopelvic disproportion.
  • Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
  • Induction of labor.
  • Cervical dilatation exceeds exceeding 4 cm.
  • Use of any other kind of analgesia before recruitment in the study.
  • Scared uterus.
  • Fetal distress.
  • Antepartum hemorrhage.
  • Intrapartum bleeding.
  • Polyhydramnios.
  • Pre-mature rupture of membranes.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Abd-El-Maeboud KH, Elbohoty AE, Mohammed WE, Elgamel HM, Ali WA. Intravenous infusion of paracetamol for intrapartum analgesia. J Obstet Gynaecol Res. 2014 Nov;40(11):2152-7. doi: 10.1111/jog.12465. Epub 2014 Aug 11.

    PMID: 25132459DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ahmed E Elbohoty, MD

    OB GYN Department, faculty of Medicine, ASU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in OB GYN

Study Record Dates

First Submitted

August 15, 2011

First Posted

September 5, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

EG(1)