Labour Analgesia and Neonate ActivityLAMBNCT01280084
Labour Analgesia and Movement in Babies
An observational study of Labour Analgesia and Neonate Activity, run by University of British Columbia at 1 site in Canada.
Trial summary
This study aims to measure movements in babies after they are born using an actigraph, a wristwatch-sized device worn on the ankle, which works similarly to the device used by runners to count the number of steps they have taken. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Analgesia and Neonate Activity
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Aug 2011
- Phase
- Observational
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women who have vaginal deliveries at BC Women's Hospital
Who may be able to join
- Neonates born to healthy women with singleton pregnancies who deliver vaginally at term gestation (> 37 weeks)
- Mothers aged 19 years or older and understand written and oral English
- Neonates who are neurologically healthy
Who cannot join
- Cesarean delivery; patients booked for cesarean delivery presenting in labour
- Maternal opioid dependence
- Maternal sedative or psychotropic medications
- Maternal combined spinal epidural (CSE) analgesia in labour
- Forceps delivery; 4th degree perineal tears
- Birth weight greater than 4.5 kg
Show all 10Show fewer
- Intrapartum fetal heart rate abnormalities requiring immediate delivery
- Neonates of mothers who receive epidural morphine for post-delivery analgesia
- Neonates requiring admission to NICU
- Neonates with obvious congenital anomalies
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Women's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: The Effect of Labour Analgesia on Babies' Movements After Birth: An Actigraphic Study
This study aims to measure movements in babies after they are born using an actigraph, a wristwatch-sized device worn on the ankle, which works similarly to the device used by runners to count the number of steps they have taken. We aim to compare the movements of babies whose mothers have received different types of pain relief in labour.
Read the detailed description
The purpose of the study is to investigate the potential utility of actigraphy, a non-invasive means of measuring an individual's movements, in distinguishing the effects of different types of maternal labour analgesia on babies after birth.
The study hypothesizes that actigraphic data can be used to differentiate the effects on neonates of different forms of maternal intrapartum analgesia. In particular, we hypothesize that infants of mothers who receive intrapartum opioid analgesia will demonstrate fewer movements than infants of mothers who receive epidural analgesia or those who receive nothing.
Whilst it is well known that drugs administered to mothers during labour can affect their babies, means of assessing this effect are complex and unreliable. A more objective means of assessing babies after birth is required, and actigraphy may represent a useful technique. Actigraphy has been used on babies in other studies in a variety of settings, including comparing babies born by different delivery modes (i.e. vaginal versus cesarean delivery) and at different gestations (i.e. term versus preterm), although none of these studies have considered maternal analgesia received prior to delivery as a possible influence on babies' movements after birth. Other studies that have looked at sleep parameters in babies, particularly measures of activity, have shown association with later indices of psychomotor development.
The objective of the study is to compare actigraph-derived movement data from babies whose mothers have received any of the commonly used analgesic techniques for labour at BC Women's Hospital.
This is a prospective observational study. Women will be assessed for eligibility for the study on admission to the labour ward. As one of the inclusion criteria is vaginal birth, women considered eligible on admission may become ineligible depending on their mode fo delivery. Information will be available to all women in the assessment rooms and consent will be specifically sought after they deliver and are deemed eligible. We plan to recruit the babies of mothers who receive analgesia in one of four categories: no analgesia or nitrous oxide only; systemically administered opioid analgesia only; epidural analgesia with an intermediate total dose of fentanyl (<150mcg); epidural analgesia with a high total dose of fentanyl (>150mcg). We recognize that women may receive several or even all of the different modalities of labour analgesia in the course of their delivery. In this situation, we will calculate the total dose fo opioid received by all routes and convert this to fentanyl equivalents for the purposes of analysis. Neonates of women who agree to participate will be fitted with an actigraph that will remain in place (except for removal for bathing) for 24 hours, or until discharge from hospital. Actigraphs are small, light-weight, wrist-watch-sized monitors that weight 16 grams. The actigraphs will be placed on the neonates' ankle, as this position has been reported to cause less disturbance to them. Parents of participating neonates will also be instructed in the use fo a daily dairy that will allow correlation of actigraphic movement data with events such as bathing (when the actigraph will necessarily be removed) and other external sources of movements (e.g. being rocked, breastfeeding).
- Conditions
- Labour Analgesia and Neonate Activity
- Keywords
- neonate activity, labour analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No labour analgesia/nitrous oxide | Women who use no analgesia during labour or who only used nitrous oxide. | |
| Systemic opioids | Women who receive only systemic opioids for analgesia during, either intravenously or intramuscularly | |
| Intermediate dose epidural fentanyl | Women who receive a total epidural fentanyl dose less than 150 micrograms | |
| High dose epidural fentanyl | Women who receive a total epidural fentanyl dose more than 150 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonates' mobile and immobile time in 24 hours
Measured: Within the first 24 hours of life
Neonates' number of mobile and immobile bouts in 24 hours
Measured: Within the first 24 hours of life
Total activity score
Measured: Within the first 24 hours of life
Secondary outcomes (2)
Neonates' total sleep time in 24 hours, night-time sleep in 24 hours and day-time sleep in 24 hours
Measured: Within the first 24 hours of life
Neonates' total number of sleep bouts
Measured: Within the first 24 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour Analgesia and Neonate ActivityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Kronitz, MD, FRCPC, Principal investigator, Department of Anesthesia BC Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280084
- Sponsor's protocol ID
- H10-02900
- Acronym
- LAMB
- Status last verified
- Feb 2012
- First submitted
- 18 Jan 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Labour Analgesia on Babies' Movements After Birth: An Actigraphic Study
- ClinicalTrials.gov ID
- NCT01280084
- Acronym / sponsor ID
- LAMB / H10-02900
- Conditions
- Labour Analgesia and Neonate Activity
- Keywords
- neonate activity, labour analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Jan 2011 (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.
This study aims to measure movements in babies after they are born using an actigraph, a wristwatch-sized device worn on the ankle, which works similarly to the device used by runners to count the number of steps they have taken. We aim to compare the movements of babies whose mothers have received different types of pain relief in labour.
Detailed description
The purpose of the study is to investigate the potential utility of actigraphy, a non-invasive means of measuring an individual's movements, in distinguishing the effects of different types of maternal labour analgesia on babies after birth.
The study hypothesizes that actigraphic data can be used to differentiate the effects on neonates of different forms of maternal intrapartum analgesia. In particular, we hypothesize that infants of mothers who receive intrapartum opioid analgesia will demonstrate fewer movements than infants of mothers who receive epidural analgesia or those who receive nothing.
Whilst it is well known that drugs administered to mothers during labour can affect their babies, means of assessing this effect are complex and unreliable. A more objective means of assessing babies after birth is required, and actigraphy may represent a useful technique. Actigraphy has been used on babies in other studies in a variety of settings, including comparing babies born by different delivery modes (i.e. vaginal versus cesarean delivery) and at different gestations (i.e. term versus preterm), although none of these studies have considered maternal analgesia received prior to delivery as a possible influence on babies' movements after birth. Other studies that have looked at sleep parameters in babies, particularly measures of activity, have shown association with later indices of psychomotor development.
The objective of the study is to compare actigraph-derived movement data from babies whose mothers have received any of the commonly used analgesic techniques for labour at BC Women's Hospital.
This is a prospective observational study. Women will be assessed for eligibility for the study on admission to the labour ward. As one of the inclusion criteria is vaginal birth, women considered eligible on admission may become ineligible depending on their mode fo delivery. Information will be available to all women in the assessment rooms and consent will be specifically sought after they deliver and are deemed eligible. We plan to recruit the babies of mothers who receive analgesia in one of four categories: no analgesia or nitrous oxide only; systemically administered opioid analgesia only; epidural analgesia with an intermediate total dose of fentanyl (<150mcg); epidural analgesia with a high total dose of fentanyl (>150mcg). We recognize that women may receive several or even all of the different modalities of labour analgesia in the course of their delivery. In this situation, we will calculate the total dose fo opioid received by all routes and convert this to fentanyl equivalents for the purposes of analysis. Neonates of women who agree to participate will be fitted with an actigraph that will remain in place (except for removal for bathing) for 24 hours, or until discharge from hospital. Actigraphs are small, light-weight, wrist-watch-sized monitors that weight 16 grams. The actigraphs will be placed on the neonates' ankle, as this position has been reported to cause less disturbance to them. Parents of participating neonates will also be instructed in the use fo a daily dairy that will allow correlation of actigraphic movement data with events such as bathing (when the actigraph will necessarily be removed) and other external sources of movements (e.g. being rocked, breastfeeding).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No labour analgesia/nitrous oxide | – | –Women who use no analgesia during labour or who only used nitrous oxide. |
| Systemic opioids | – | –Women who receive only systemic opioids for analgesia during, either intravenously or intramuscularly |
| Intermediate dose epidural fentanyl | – | –Women who receive a total epidural fentanyl dose less than 150 micrograms |
| High dose epidural fentanyl | – | –Women who receive a total epidural fentanyl dose more than 150 micrograms |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women who have vaginal deliveries at BC Women's Hospital
Key inclusion criteria (3 listed)
- Neonates born to healthy women with singleton pregnancies who deliver vaginally at term gestation (> 37 weeks)
- Mothers aged 19 years or older and understand written and oral English
- Neonates who are neurologically healthy
Key exclusion criteria (10 listed)
- Cesarean delivery; patients booked for cesarean delivery presenting in labour
- Maternal opioid dependence
- Maternal sedative or psychotropic medications
- Maternal combined spinal epidural (CSE) analgesia in labour
- Forceps delivery; 4th degree perineal tears
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neonates' mobile and immobile time in 24 hours
Time frame: Within the first 24 hours of life
Neonates' number of mobile and immobile bouts in 24 hours
Time frame: Within the first 24 hours of life
Total activity score
Time frame: Within the first 24 hours of life
2 secondary outcomes
Neonates' total sleep time in 24 hours, night-time sleep in 24 hours and day-time sleep in 24 hours
Time frame: Within the first 24 hours of life
Neonates' total number of sleep bouts
Time frame: Within the first 24 hours of life
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 14 Feb 2012.
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.
Naomi Kronitz, MD, FRCPC principal investigator
Department of Anesthesia BC Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labour Analgesia and Neonate Activity, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 10 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 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Neonates' mobile and immobile time in 24 hours (time frame: Within the first 24 hours of life). The study lists 3 primary outcomes in all. 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 14 Feb 2012.