NCT03035045

Brief Summary

This randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. The experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 27, 2017

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

November 16, 2016

Last Update Submit

January 26, 2017

Conditions

Amniocentesis

Outcome Measures

Primary Outcomes (1)

  • Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).

    1 yrs

Study Arms (2)

Comparator1: Paracetamol 650 mg (325 mg/tablet) oral

EXPERIMENTAL

Drug: Paracetamol Comparison pain score between paracetamol and placebo

Drug: Paracetamol

Comparator 2: Placebo oral

PLACEBO COMPARATOR

Drug: placebo Comparison pain score between paracetamol and placebo

Drug: Placebo Oral Tablet

Interventions

ParacetamolDRUG
Comparator1: Paracetamol 650 mg (325 mg/tablet) oral
Placebo Oral TabletDRUG
Comparator 2: Placebo oral

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnant women undergo amniocentesis for the first time at Rajavithi Hospital in 2016-2017

You may not qualify if:

  • Pregnant women with psychiatric disorder
  • Contraindicated to paracetamol
  • Pregnant women undergoing amniocentesis due to fetal anomaly
  • Take oral paracetamol or other analgesics within 24-48 hrs before operation
  • Deny to participate the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

January 27, 2017

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

January 27, 2017

Record last verified: 2016-11

Locations

TH(1)