Latent Phase LabourNCT00225329
Early Labour Assessment and Support at Home
A study testing Labour assessment and support in people with Latent Phase Labour, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Latent Phase Labour
- What is being tested?
- Labour assessment and support
- Type of treatment
- Surgery or procedure
- How many people
- 1,466 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Aug 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Early Labour Support at Home: RCT of Nurse Visits and Telephone Triage
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.
Read the 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.
- Conditions
- Latent Phase Labour
- Being tested
- Labour assessment and support
- Keywords
- RCT, intervention study, labour management, assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labour assessment and supportProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
• need for Intermittent Positive Pressure Ventilation by mask or endotracheal tube at birth
• newborn admission to level II or III nursery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2001
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Phase LabourStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,466 participants
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Patricia Janssen, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225329
- Sponsor's protocol ID
- C01-0083
- Status last verified
- Sep 2005
- First submitted
- 21 Sep 2005
- Last updated
- 23 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Labour Support at Home: RCT of Nurse Visits and Telephone Triage
- ClinicalTrials.gov ID
- NCT00225329
- Acronym / sponsor ID
- C01-0083
- Conditions
- Latent Phase Labour
- Keywords
- RCT, intervention study, labour management, assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,466 participants
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2001
- Study completion
- Aug 2004
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labour assessment and support | Procedure or surgery | – |
Primary outcome
Rate of cesarean section
7 secondary outcomes
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2005.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Janssen, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Labour assessment and support in people with Latent Phase Labour, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cesarean section. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2005.