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Early Labour Assessment and Support at Home

Primary Purpose

Latent Phase Labour

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Labour assessment and support
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Latent Phase Labour focused on measuring RCT, intervention study, labour management, assessment

Eligibility Criteria

16 Years - 42 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pre-registered to deliver at BC Women's or Surrey Memorial Hospital Living within a 30-minute drive of the hospital Age 16-42 37-42 completed weeks of gestation Singleton fetus in the vertex position Telephone in the home Speaks English, Cantonese, Mandarin or Punjabi Nulliparous Exclusion Criteria: 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Rate of cesarean section

    Secondary Outcome Measures

    • 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
    • need for Intermittent Positive Pressure Ventilation by mask or endotracheal tube at birth
    • newborn admission to level II or III nursery

    Full Information

    First Posted
    September 21, 2005
    Last Updated
    September 21, 2005
    Sponsor
    University of British Columbia
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00225329
    Brief Title
    Early Labour Assessment and Support at Home
    Official Title
    Early Labour Support at Home: RCT of Nurse Visits and Telephone Triage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2004 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of British Columbia
    Collaborators
    Canadian Institutes of Health Research (CIHR)

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    Nurses hired by the early labour and support at home (ELASH) study will be situated in the assessment/triage areas of each hospital to recruit subjects for 24 hours per day, seven days per week. After randomization, the study nurse will inform the triage nurses of which arm of the trial the patient has been assigned to. The triage nurses will then provide either of the following interventions. Telephone Triage In the telephone triage group (standard of care in both hospitals) women will be asked over the phone about the nature and frequency of contractions, presence of bloody show, status of membranes, parity, gestational age, and complications of pregnancy. Based on this information, the nurse will advise the woman as to whether or not to come to hospital. A detailed protocol which outlines telephone documentation, advice-giving and teaching is included in Appendix 1. Patients who are assessed by telephone not to be in active labour are advised not to come to hospital. In the event that they come anyway, they will receive a hands on assessment (similar to the home visit group) and if assessed not to be in active labour, they will be sent home and encouraged to return home and call in again if they feel that their labour is becoming active. Home visit by a Nurse Women randomised to the nurse visiting group will be told that a nurse will be leaving the hospital immediately. After obtaining directions to the residence and leaving this information with the charge nurse, the triage nurse will depart. The nursing assessment at home is identical to that which takes place in the triage area of the hospital. It includes a brief history, maternal vital signs, abdominal palpation, auscultation of the fetal heart rate, assessment of contractions, and an examination of the cervix. Comfort measures such as positioning, massage, showering, walking interspersed with resting, use of hot and cold packs, and relaxation techniques will be taught to the woman and her support persons as needed. These will be the same as those outlined in the protocols for telephone triage related to patient teaching. (Appendix 1) Standard advice as outlined in the telephone triage protocol will be given in regard to when to come in to hospital, such as if amniotic fluid is coloured, vaginal bleeding is occurring, contractions were more frequent than 2/10 minutes or lasting longer than 60 seconds or simply too uncomfortable to manage at home. Women in this arm may be visited more than once. The nurse will be in telephone contact with the woman between visits. The nurse will advise the physician of the patient's status from the patient's home. Information related to the home visit is documented on the same form as the telephone documentation with the addition of information from "hands on" assessment, including maternal vital signs, abdominal palpation, fetal heart rate, assessment of cervical dilation and strength of contractions. If remaining at home after the nurse's visit, women will be taught how to contact the nurse on her cellular phone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Latent Phase Labour
    Keywords
    RCT, intervention study, labour management, assessment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1466 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Labour assessment and support
    Primary Outcome Measure Information:
    Title
    Rate of cesarean section
    Secondary Outcome Measure Information:
    Title
    • rates of admission to the delivery suite of women in the latent phase of labour (< 3 cm of cervical dilatation)
    Title
    • augmentation of labour, either surgically or medically
    Title
    • use of narcotic given intravenously or intramuscularly in labour
    Title
    • use of epidural analgesia.
    Title
    • Newborn Apgar scores at 1 and 5 minutes
    Title
    • need for Intermittent Positive Pressure Ventilation by mask or endotracheal tube at birth
    Title
    • newborn admission to level II or III nursery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pre-registered to deliver at BC Women's or Surrey Memorial Hospital Living within a 30-minute drive of the hospital Age 16-42 37-42 completed weeks of gestation Singleton fetus in the vertex position Telephone in the home Speaks English, Cantonese, Mandarin or Punjabi Nulliparous Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia Janssen, PhD
    Organizational Affiliation
    University of British Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Early Labour Assessment and Support at Home

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