PreeclampsiaNCT02633995
Spinal Anaesthesia and Severe Preeclampsia
An observational study of Preeclampsia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation However, the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- spinal anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Feb 2016
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: two equal groups (n=30), Pregnant females with severe pre-eclampsia : (group A) and normotensive parturients (group B) presenting for full term delivery with caesarean section using spinal anesthesia at Kasr Al Aini hospital in the duration of 3 months from december 2015 to march 2016 will be included.
Who may be able to join
- Age: 18 - 40 years
- Severely Pre-eclamptic females, severe pre-eclampsia is defined as hypertension( BP > 159/109) ,proteinuria ( urinary protein excretion of greater than 5 gm per day) and oliguria(<500 ml in 24 hours) with at least one maternal organ dysfunction .
Who cannot join
- Age : <18 years
- Obese patients with BMI > 35 Kg/m2
- Preterm delivery
- Patients with contraindication to spinal anesthesia.
- Patients in active labor
Trial locations and contacts
1 site in 1 country.
mina ad helmy contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
ahmed ib elsakka, m.d., 00201002424221, ahmedsakka2@hotmail.com
About this study
Official title: Spinal Anesthesia in Severe Preeclampsia and Its Impact on Hemodynamics (Case Control Study)
The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation However, the incidence of hypotension is high during spinal anesthesia for Cesarean section and it may approach values up to 95 %.
Read the detailed description
The parturient will be allocated into one of two equal groups (n=30), a severe preeclampsia group (A) and a normotensive group (B). All will receive colload (500 ml voluven) as a coload via wide bore (16 Gauge ) cannula within 5-10 minutes during induction of spinal anesthesia. Standard monitoring with electrocardiography, automated non-invasive arterial pressure (NIAP) measurement, and pulse oximetry will be performed. Systolic arterial pressure (SAP), mean arterial pressure (MAP) and diastolic arterial pressure (DAP) will be monitored. Baseline values will be recorded in the supine position. Central venous line will be inserted in severe preeclampsia group and central venous pressure will be measured every 10 minutes.
Spinal anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.
- Conditions
- Preeclampsia
- Being tested
- spinal anaesthesia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anaesthesiaProcedure or surgery
regional anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.
| Study group | Role | What they receive |
|---|---|---|
| preeclampsia | spinal anaesthesia will be given for cesarean section Receives: Procedure: spinal anaesthesia | |
| normotensive | spinal anaesthesia will be given for cesarean section Receives: Procedure: spinal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants showing significant hemodynamic changes in response to spinal anesthesia as detected by hemodynamic monitors (blood pressure, heart rate and oxygen saturation)
Measured: 3 months
Secondary outcomes (1)
Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed elsakka, Cairo University
- Investigators
- maher fawzy, m.d., Study director, department of anaesthesia faculty of medicine cairo universitynisreen refaie, m.d., Study chair, department of anaesthesia faculty of medicine cairo universityahmed elsakka, m.d., Study chair, department of anaesthesia faculty of medicine cairo universitymina helmy, Principal investigator, department of anaesthesia faculty of medicine cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633995
- Sponsor's protocol ID
- Mina
- Status last verified
- Dec 2015
- First submitted
- 6 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia in Severe Preeclampsia and Its Impact on Hemodynamics (Case Control Study)
- ClinicalTrials.gov ID
- NCT02633995
- Acronym / sponsor ID
- Mina
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (estimated)
- First posted
- 17 Dec 2015 (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 use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation However, the incidence of hypotension is high during spinal anesthesia for Cesarean section and it may approach values up to 95 %.
Detailed description
The parturient will be allocated into one of two equal groups (n=30), a severe preeclampsia group (A) and a normotensive group (B). All will receive colload (500 ml voluven) as a coload via wide bore (16 Gauge ) cannula within 5-10 minutes during induction of spinal anesthesia. Standard monitoring with electrocardiography, automated non-invasive arterial pressure (NIAP) measurement, and pulse oximetry will be performed. Systolic arterial pressure (SAP), mean arterial pressure (MAP) and diastolic arterial pressure (DAP) will be monitored. Baseline values will be recorded in the supine position. Central venous line will be inserted in severe preeclampsia group and central venous pressure will be measured every 10 minutes.
Spinal anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclampsia | – | Procedure: spinal anaesthesiaspinal anaesthesia will be given for cesarean section |
| normotensive | – | Procedure: spinal anaesthesiaspinal anaesthesia will be given for cesarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- two equal groups (n=30), Pregnant females with severe pre-eclampsia : (group A) and normotensive parturients (group B) presenting for full term delivery with caesarean section using spinal anesthesia at Kasr Al Aini hospital in the duration of 3 months from december 2015 to march 2016 will be included.
Key inclusion criteria (2 listed)
- Age: 18 - 40 years
- Severely Pre-eclamptic females, severe pre-eclampsia is defined as hypertension( BP > 159/109) ,proteinuria ( urinary protein excretion of greater than 5 gm per day) and oliguria(<500 ml in 24 hours) with at least one maternal organ dysfunction .
Key exclusion criteria (5 listed)
- Age : <18 years
- Obese patients with BMI > 35 Kg/m2
- Preterm delivery
- Patients with contraindication to spinal anesthesia.
- Patients in active labor
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 |
|---|---|---|
| spinal anaesthesiaregional anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt. | Procedure or surgery | normotensive, preeclampsia |
Primary outcome
Percentage of participants showing significant hemodynamic changes in response to spinal anesthesia as detected by hemodynamic monitors (blood pressure, heart rate and oxygen saturation)
Time frame: 3 months
1 secondary outcome
Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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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.
mina ad helmy contact
maher fawzy, m.d. study director
department of anaesthesia faculty of medicine cairo university
nisreen refaie, m.d. study chair
department of anaesthesia faculty of medicine cairo university
ahmed elsakka, m.d. study chair
department of anaesthesia faculty of medicine cairo university
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 Preeclampsia, run by Kasr El Aini Hospital at 1 site in Egypt.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Dec 2015. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed ib elsakka, m.d. (00201002414221, ahmedsakka2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants showing significant hemodynamic changes in response to spinal anesthesia as detected by hemodynamic monitors (blood pressure, heart rate and oxygen saturation) (time frame: 3 months). 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 Dec 2015.