NCT00426725

Brief Summary

The suggested research is aimed to test the effectiveness of an external mechanical device to be applied and used by the parturient herself in pain relieving during labour . The research is to be performed in a controlled closely observed way, to ensure the safety of the involved parturient and newborn.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

10 months

First QC Date

January 23, 2007

Last Update Submit

July 30, 2008

Conditions

Labour Pain

Keywords

laborpainrelieflabourdevice

Outcome Measures

Primary Outcomes (1)

  • Mosby Pain Rating Scale (VAS)

    6 Months

Study Arms (2)

A

EXPERIMENTAL

This group uses the EasyLabour device according to the protocol

Device: EasyLabour

Control

NO INTERVENTION
Device: EasyLabour

Interventions

EasyLabourDEVICE

According to the trial protocol

AControl

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with low-risk normal pregnancies.
  • Healthy women, age 18 years or more.
  • Single pregnancy
  • At active labour, with contractions and labour pain.

You may not qualify if:

  • Women at high risk pregnancies (with Diabetes Mellitus, Arterial Hypertension, multiple fetal pregnancy, abnormal amniotic fluid index, Intra Uterine growth restriction(IUGR), or any situation which might imply placental insufficiency)
  • Caesarean sections in the past
  • Any contraindication to vaginal delivery (as breech presentation or Placenta Previa).
  • Any active illness, abnormal body temperature, Fatigue, etc.
  • Women complaining of any pain nonrelated to labour.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laniado Hospital - Sanz Medical Center

Netanya, Israel

Location

MeSH Terms

Conditions

Labor PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shay Kevorkian, MD

    Laniado Sanz Hospital - Netanya - Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 25, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

IL(1)