NCT00225329

Brief Summary

To determine, among healthy first time mothers who are uncertain as to when to come to hospital in labour, if home visits by obstetrical nurses compared to telephone advice have an impact on reducing cesarean section rate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,466

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2001

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2001

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

September 23, 2005

Status Verified

September 1, 2005

First QC Date

September 21, 2005

Last Update Submit

September 21, 2005

Conditions

Latent Phase Labour

Keywords

RCTintervention studylabour managementassessment

Outcome Measures

Primary Outcomes (1)

  • Rate of cesarean section

Secondary Outcomes (7)

  • • rates of admission to the delivery suite of women in the latent phase of labour (< 3 cm of cervical dilatation)

  • • augmentation of labour, either surgically or medically

  • • use of narcotic given intravenously or intramuscularly in labour

  • • use of epidural analgesia.

  • • Newborn Apgar scores at 1 and 5 minutes

  • +2 more secondary outcomes

Interventions

Labour assessment and supportPROCEDURE

Eligibility Criteria

Age16 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pre-registered to deliver at BC Women's or Surrey Memorial Hospital
  • Living within a 30-minute drive of the hospital
  • Age 16-42
  • completed weeks of gestation
  • Singleton fetus in the vertex position
  • Telephone in the home
  • Speaks English, Cantonese, Mandarin or Punjabi
  • Nulliparous

You may not qualify if:

  • Women whose primary caregivers are midwives. (women who are receiving midwifery care are excluded because midwives routinely visit their clients in early labour at home. At present there are only 30 midwife-attended births per month in both hospitals combined.)
  • Women whose prenatal record (forwarded to the hospital at 36 weeks) documents abnormalities of the placenta, diabetes, either gestational or pre-existing, maternal cardio-vascular or renal dysfunction, fetal anomalies or abnormal amniotic fluid volumes, or any other concern documented on the prenatal form which would preclude the parturient labouring in the latent phase of labour at home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Patricia Janssen, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

September 1, 2001

Study Completion

August 1, 2004

Last Updated

September 23, 2005

Record last verified: 2005-09