Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section
Difference in the Frequency of Episodes of Respiratory Depression Between Obese (BMI≥30) and Women With Normal BMI Receiving Spinal Anesthesia Combined With Intrathecal Morphine During Elective Caesarean Section
1 other identifier
interventional
30
1 country
1
Brief Summary
The study will examine whether there is a difference in the frequencies of respiratory depression among obese women receiving spinal anesthesia combined with opioids compared to women with normal BMI. If such a risk exists further investigation will be required to establish the proper criteria for the administration of morphine with spinal anesthesia to obese women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedMay 30, 2018
May 1, 2018
1.2 years
June 15, 2016
May 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of clinical respiratory depression by SOMNOtouchTM device monitoring
one year
Study Arms (4)
women BMI<30 POD 1
ACTIVE COMPARATORPregnant healthy women with BMI\<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.
women BMI≥30 POD 1
ACTIVE COMPARATORPregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 1 after elective cesarean section.
women BMI<30 POD4
ACTIVE COMPARATORPregnant healthy women with BMI\<30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.
women BMI≥30 POD 4
ACTIVE COMPARATORPregnant healthy women with BMI≥30 receiving spinal anesthesia with intrathecal morphine during elective caesarean section will be monitored by SOMNOTOUCH RESP post operative day 4 after elective cesarean section.
Interventions
Ventilatory effort recorder
Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
Eligibility Criteria
You may qualify if:
- Pregnancy
- Healthy women
You may not qualify if:
- Heart diseases
- Autoimmune diseases
- Respiratory diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam healthcare campus
Haifa, Isreal, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 30, 2016
Study Start
May 1, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
May 30, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share