Cesarean DeliveryNCT00616174
Does Warming Mothers During Cesarean Delivery Help Keep Babies Warm When Delivered?
A study testing Active warming with Bair Hugger blanket in people with Cesarean Delivery, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study to investigate whether using a special warming blanket during Cesarean delivery helps maintain a normal body temperature in the baby when compared to mothers that are not warmed (standard care at BC Women's Hospital). 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
- Cesarean Delivery
- What is being tested?
- Active warming with Bair Hugger blanket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Jul 2008
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women undergoing elective cesarean delivery under spinal anesthesia or combined spinal epidural anesthesia
- Greater than 28 weeks gestation
- ASA 1 \& 2 classification of health
- Mothers presenting to the assessment or labour and delivery unit with ruptured membranes or early signs of labour, but not in active labour, who are not planned for a vaginal birth and who need an urgent cesarean delivery
- Potential subjects need to be able to read and understand English unless independent (non-partner) translator available
Who cannot join
- Mothers in active labour - 3cm or more dilated with regular coordinated contractions
- ASA 3 or above
- Emergency cesarean delivery for fetal heart rate abnormalities
- Cesarean delivery under general anesthesia
- Maternal age <19 years
- Maternal infection
Show all 12Show fewer
- Mothers with a CSE where > 5ml of epidural local anesthetic is given prior to the delivery of the fetus
- Mothers with vascular disease - with the exception of hypertension/pre-eclampsia
- Mothers with Type I Diabetes Mellitus
- Untreated hypothyroidism or hyperthyroidism
- Mothers with a history or family history of malignant hyperthermia
- Those who cannot understand English, and lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Maternal Warming During Cesarean Delivery on Neonatal Temperature
The purpose of this study to investigate whether using a special warming blanket during Cesarean delivery helps maintain a normal body temperature in the baby when compared to mothers that are not warmed (standard care at BC Women's Hospital). Doctors observed that some babies have low body temperatures when they are born by Cesarean delivery. Since baby temperatures are dependant on the temperatures of their mothers, we believe that keeping the mother warm during surgery with the use of a special warming blanket that is filled with warm air will result in the baby being warmer at birth.
Read the detailed description
Maternal hypothermia during Cesarean delivery is predominately caused by a combination of neuraxial anesthesia and exposure of abdominal contents and skin to the low temperatures of the operating room (OR). Since maternal temperature and fetal temperature are intimately related, neonates experience hypothermia at birth due to maternal hypothermia. Neonatal hypothermia on admission to the Intensive Care Unit is an important determinant of morbidity and mortality, particularly in preterm neonates.
At BC Women's Hospital the majority of Cesarean deliveries are done under neuraxial anesthesia and the pediatricians have observed that some babies had suboptimal body temperatures at the time of Cesarean delivery. The pediatricians wanted to reverse this trend in neonatal hypothermia and requested that the OR temperature be increased to 25oC, more in line with World Health Organization (WHO) guidelines for delivery rooms. However, raising OR temperatures is usually not a comfortable option to the majority of staff working in this environment, therefore WHO recommendations are not followed.
Forced air warming is a common technique used during surgical procedures to maintain normothermia in anesthetized patients. A bi-layered blanket with multiple air channels is connected to a warming device that forces warm air between the layers of the blanket and ultimately around the patient. This device is effective in warming hypothermic patients or maintaining temperature in normothermic patients in a cool OR.
The studies on maternal warming at Cesarean delivery that have been published to date have shown inconsistent findings thus the subject warrants further investigation.
We postulate that actively warming mothers will prevent or decrease the risk of neonatal hypothermia at birth. In addition, we will examine whether active warming has a larger effect in the premature neonate.
Neonatal axillary temperature at delivery will be our primary outcome.
Important variables measured include: neonatal umbilical vein pH, Apgar scores, maternal temperature throughout surgery (uterine incision -delivery time), presence of maternal shivering and maternal thermal comfort score.
This study will be a non-blinded, randomized controlled trial involving two groups:
- Control group: Standard care i.e. cupboard warmed cotton blanket and cupboard warmed IV fluids.
- Intervention group: Standard care as in control group plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C).
The intervention group will receive a forced air warming blanket throughout surgery.
The study will be conducted in the operating room at the BC Women's Hospital.
The target population is consenting, pregnant women undergoing either elective or urgent (no immediate threat to maternal or neonatal life but requiring delivery) Cesarean delivery under spinal or combined spinal-epidural anesthesia.
Exclusion factors include: emergency Cesarean deliveries or Cesarean deliveries under general anesthesia, mothers in active labor, mothers under 19 years old, those who cannot understand English, and lack of consent. Mothers with a suspected infection, Type I Diabetes Mellitus, a history of malignant hyperthermia and any disease/disorder that is known to affect temperature regulation will also be excluded.
- Conditions
- Cesarean Delivery
- Being tested
- Active warming with Bair Hugger blanket
- Keywords
- Cesarean delivery, Active Warming, Neonatal Temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active warming with Bair Hugger blanketProcedure or surgery
Standard care at BC Women's Hospital plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C). Warming will continue until the end of surgery unless otherwise requested by the mother.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Active warming with Bair Hugger blanket Receives: Procedure: Active warming with Bair Hugger blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal axillary temperature at delivery
Measured: During delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Preston Roanne, MD, Principal investigator, University of British ColumbiaJoanne Douglas, MD, FRCPC, Study director, University of British ColumbiaJason Reidy, MBBS, FRCA, Study director, University of British ColumbiaSimon Massey, MB BCh, MRCP, FRCA, Study director, University of British ColumbiaRebecca Sherlock, MD, FRCPC, FAAP, PhD, Study director, University of British ColumbiaJessica Tyler, BSc, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616174
- Sponsor's protocol ID
- H07-01490
- Other IDs
- H07-01490
- Status last verified
- Mar 2014
- First submitted
- 5 Feb 2008
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maternal Warming During Cesarean Delivery on Neonatal Temperature
- ClinicalTrials.gov ID
- NCT00616174
- Acronym / sponsor ID
- H07-01490
- Conditions
- Cesarean Delivery
- Keywords
- Cesarean delivery, Active Warming, Neonatal Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 15 Feb 2008 (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.
The purpose of this study to investigate whether using a special warming blanket during Cesarean delivery helps maintain a normal body temperature in the baby when compared to mothers that are not warmed (standard care at BC Women's Hospital). Doctors observed that some babies have low body temperatures when they are born by Cesarean delivery. Since baby temperatures are dependant on the temperatures of their mothers, we believe that keeping the mother warm during surgery with the use of a special warming blanket that is filled with warm air will result in the baby being warmer at birth.
Detailed description
Maternal hypothermia during Cesarean delivery is predominately caused by a combination of neuraxial anesthesia and exposure of abdominal contents and skin to the low temperatures of the operating room (OR). Since maternal temperature and fetal temperature are intimately related, neonates experience hypothermia at birth due to maternal hypothermia. Neonatal hypothermia on admission to the Intensive Care Unit is an important determinant of morbidity and mortality, particularly in preterm neonates.
At BC Women's Hospital the majority of Cesarean deliveries are done under neuraxial anesthesia and the pediatricians have observed that some babies had suboptimal body temperatures at the time of Cesarean delivery. The pediatricians wanted to reverse this trend in neonatal hypothermia and requested that the OR temperature be increased to 25oC, more in line with World Health Organization (WHO) guidelines for delivery rooms. However, raising OR temperatures is usually not a comfortable option to the majority of staff working in this environment, therefore WHO recommendations are not followed.
Forced air warming is a common technique used during surgical procedures to maintain normothermia in anesthetized patients. A bi-layered blanket with multiple air channels is connected to a warming device that forces warm air between the layers of the blanket and ultimately around the patient. This device is effective in warming hypothermic patients or maintaining temperature in normothermic patients in a cool OR.
The studies on maternal warming at Cesarean delivery that have been published to date have shown inconsistent findings thus the subject warrants further investigation.
We postulate that actively warming mothers will prevent or decrease the risk of neonatal hypothermia at birth. In addition, we will examine whether active warming has a larger effect in the premature neonate.
Neonatal axillary temperature at delivery will be our primary outcome.
Important variables measured include: neonatal umbilical vein pH, Apgar scores, maternal temperature throughout surgery (uterine incision -delivery time), presence of maternal shivering and maternal thermal comfort score.
This study will be a non-blinded, randomized controlled trial involving two groups:
- Control group: Standard care i.e. cupboard warmed cotton blanket and cupboard warmed IV fluids.
- Intervention group: Standard care as in control group plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C).
The intervention group will receive a forced air warming blanket throughout surgery.
The study will be conducted in the operating room at the BC Women's Hospital.
The target population is consenting, pregnant women undergoing either elective or urgent (no immediate threat to maternal or neonatal life but requiring delivery) Cesarean delivery under spinal or combined spinal-epidural anesthesia.
Exclusion factors include: emergency Cesarean deliveries or Cesarean deliveries under general anesthesia, mothers in active labor, mothers under 19 years old, those who cannot understand English, and lack of consent. Mothers with a suspected infection, Type I Diabetes Mellitus, a history of malignant hyperthermia and any disease/disorder that is known to affect temperature regulation will also be excluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Active warming with Bair Hugger blanketActive warming with Bair Hugger blanket |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All women undergoing elective cesarean delivery under spinal anesthesia or combined spinal epidural anesthesia
- Greater than 28 weeks gestation
- ASA 1 \& 2 classification of health
- Mothers presenting to the assessment or labour and delivery unit with ruptured membranes or early signs of labour, but not in active labour, who are not planned for a vaginal birth and who need an urgent cesarean delivery
- Potential subjects need to be able to read and understand English unless independent (non-partner) translator available
Key exclusion criteria (12 listed)
- Mothers in active labour - 3cm or more dilated with regular coordinated contractions
- ASA 3 or above
- Emergency cesarean delivery for fetal heart rate abnormalities
- Cesarean delivery under general anesthesia
- Maternal age <19 years
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 |
|---|---|---|
| Active warming with Bair Hugger blanketStandard care at BC Women's Hospital plus a Bair Hugger full access underbody blanket model 635 (Health Canada Licence # 12692) warmed by Bair Hugger temperature management unit model 750. Patient will lie on the underbody blanket and it will be turned on once patient is supine on operating table following the insertion of anesthetic. The warming device will be set to the medium temperature setting (380C). Warming will continue until the end of surgery unless otherwise requested by the mother. | Procedure or surgery | 1 |
Primary outcome
Neonatal axillary temperature at delivery
Time frame: During delivery
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 17 Mar 2014.
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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.
Preston Roanne, MD principal investigator
University of British Columbia
Joanne Douglas, MD, FRCPC study director
University of British Columbia
Jason Reidy, MBBS, FRCA study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active warming with Bair Hugger blanket in people with Cesarean Delivery, 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 5 inclusion and 12 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 17 Mar 2014. 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?
Neonatal axillary temperature at delivery (time frame: During delivery). 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 17 Mar 2014.