Plain English Summary
Background and study aims
An emergent (or emergency) caesarean section is one of the biggest challenges faced by an obstetric anaesthetist. As the outcome for both mother and unborn baby depends on the coordination and vigilance of the obstetrician and anaesthetist, the decision on what anesthetic technique to use can be of paramount importance. Current guidelines suggest regional (local) anaesthesia should be given in preference to general anaesthesia for elective (pre-planned) caesarean sections. However, for an emergency caesarean section, there may not be enough time to give a regional anaesthetic. Evidence does suggest that regional anaesthesia should be chosen in preference to general anaesthesia if there is time. However, there are few published studies looking at the neonatal morbidity (disease causing) for emergency caesareans where the baby has been identified as being in distress (foetal distress). In this study, neonatal morbidity will be compared for emergency caesarean sections carried out using regional anaesthesia compared with general anaesthesia.
Who can participate?
Women aged 18-45 in labour where their unborn baby is showing signs of distress.
What does the study involve?
For each patient in the study, the senior anaesthetist decides the type of anaesthesia according to both national guidelines and patients’ approval. The patients are divided into two groups, general anaesthesia group (group g) or regional anaesthesia group (group r). Heart rate, arterial tension pressure and demographic data are all recorded for each patient. Once the baby is born, APGAR scores (a way of summarising the health of a newborn baby) are recorded one minute after birth and then again at 3 minutes and 5 minutes after birth. If the babies condition is critical and there are umbilical blood gases (suggesting foetal distress) this data is also recorded. After the operation , the neonates are followed up until their discharge from hospital. Any morbid (disease-causing) conditions are also recorded.
What are the possible benefits and risks of participating?
There is no risk for the participants because it is an observational study.
Where is the study run from?
Suleymaniye Birth and Women's Health Education and Research Hospital, Istanbul (Turkey)
When is the study starting and how long is it expected to run for?
July 2015 to December 2015
Who is funding the study?
Suleymaniye Birth and Women's Health Education and Research Hospital, Istanbul (Turkey)
Who is the main contact?
Dr Ipek Saadet Edipoglu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of anaesthetic technique on neonatal morbidity in emergent caesarean section for fetal distress: a prospective observational study
Acronym
Study hypothesis
To investigate the effect of anesthetic technique on neonatal morbidity in emergent cesareans by observing if administering regional anesthesia or general anesthesia influences the morbidity of the neonate.
Ethics approval
Research Hospital Clinical Studies Ethical Committee, 29/06/2015, ref: 2015/127
Study design
Single centered prospective observational study.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Fetal distress and anesthetic technique
Intervention
We are going to observe emergent cesarean sections which are diagnosed as fetal distress. We are not going to intervene regarding the patients anesthetic choice. Regional anesthesia or general anesthesia will be applied according to the patients indication. The consultant anesthesiologist makes the decision about the type of anesthesia for emergent cesarean sections according to our national guidelines in our hospital. We are just going to observe and divide them into two groups: general anesthesia group and regional anesthesia group. The following will be recorded in all cases:
1. All patients peri-operative heart rate and mean arterial pressures
2. All neonates APGAR scores at 1, 3 and 5 minutes
3. The need for mechanical ventilation will also be recorded.
4. All morbid conditions
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Neonatal morbidity, measured with APGAR scores in 1st, 3rd, 5th minutes, and umbilical blood gas (if indicated). After the operation we will follow neonates until discharge and record any morbid conditions. We define morbidity as 5-minute Apgar score (APGAR5) <7, any need for mechanical ventilation, any neonatal intensive care unit entrance and any respiratory insufficiency symptoms.
Secondary outcome measures
Morbidity of the mother if administering regional anesthesia compared to general anesthesia
Overall trial start date
01/07/2015
Overall trial end date
06/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female
2. Age between 18-45
3. BMI<40
4. Patients diagnosed as being in fetal distress.
5. Patients without neurological diseases
6. Patients consenting to join the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60 patients will be included.
Participant exclusion criteria
1. Age less than 18 and older than 45
2. BMI>40
3. Patients that refuse to join study
Recruitment start date
01/07/2015
Recruitment end date
06/12/2015
Locations
Countries of recruitment
Turkey
Trial participating centre
Suleymaniye Birth And Women's Health Education And Research Hospital
Telsiz Mah. Balıklı Kazlıcesme Yolu No:1 Zeytinburnu
Istanbul
34116
Turkey
Funders
Funder type
Hospital/treatment centre
Funder name
Suleymaniye Birth And Women's Health Education And Research Hospital (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
01/02/2016
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30444916