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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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).

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 groups in NCT01280084
Study groupRoleWhat they receive
No labour analgesia/nitrous oxideWomen who use no analgesia during labour or who only used nitrous oxide.
Systemic opioidsWomen who receive only systemic opioids for analgesia during, either intravenously or intramuscularly
Intermediate dose epidural fentanylWomen who receive a total epidural fentanyl dose less than 150 micrograms
High dose epidural fentanylWomen 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.

  1. Neonates' mobile and immobile time in 24 hours

    Measured: Within the first 24 hours of life

  2. Neonates' number of mobile and immobile bouts in 24 hours

    Measured: Within the first 24 hours of life

  3. Total activity score

    Measured: Within the first 24 hours of life

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted20 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

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)
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

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.

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