- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00225329
Early Labour Assessment and Support at Home
Early Labour Support at Home: RCT of Nurse Visits and Telephone Triage
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of cesarean section
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Secondary Outcome Measures
Outcome Measure |
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• rates of admission to the delivery suite of women in the latent phase of labour (< 3 cm of cervical dilatation)
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• augmentation of labour, either surgically or medically
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• use of narcotic given intravenously or intramuscularly in labour
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• use of epidural analgesia.
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• Newborn Apgar scores at 1 and 5 minutes
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• need for Intermittent Positive Pressure Ventilation by mask or endotracheal tube at birth
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• newborn admission to level II or III nursery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Janssen, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C01-0083
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