PreeclampsiaNCT05237011
Peripartum Anesthetic Management of Patients With Preeclampsia
An observational study of Preeclampsia, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The investigators will conduct a prospective, observational multicentral international study of perioperative management of patients with preeclampsia. The data will be collected from the maternity files and information systems of the medical centers including obstetric, anesthetic and neonatal parameters according to… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 1,500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2022to 1 Jan 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parturient with diagnosis of preeclampsia that delivered by cesarean section.
Who may be able to join
- Parturient with diagnosis of preeclampsia for Cesarean Section
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripartum Anesthetic Management of Patients With Preeclampsia: Prospective Cohort International Observational Study
The investigators will conduct a prospective, observational multicentral international study of perioperative management of patients with preeclampsia. The data will be collected from the maternity files and information systems of the medical centers including obstetric, anesthetic and neonatal parameters according to the attached Excel data table.
Results of the study will help to improve the management of patients with preeclampsia and will help to understand the nature and rate of complications. In addition, the study will help in comparing collected data to the data in the literature and as a result improve the safety of care and service that these patient receive in the institution.
Read the detailed description
In recent years, there has been a growing interest in anesthetic management of parturients diagnosed with preeclampsia.
The management of patients with preeclampsia is influenced by maternal conditions that include airway changes, coagulation dysfunction and significant hemodynamic changes.
Without changing regular practice the investigators will observe and collect data about: the type of anesthesia during surgery, perioperative monitoring and management of these patients (please see study outcomes). Complications reported in the literature include significant elevated blood pressure during laryngoscopy and development of intracranial hemorrhage, spinal/epidural bleeding during neuraxial anesthesia in patients with preeclampsia, and coagulation abnormalities.
Although the number of patients diagnosed with preeclampsia is estimated at five to ten percent of the general maternity population, there is a lack of prospective studies regarding the anesthetic management, obstetric complications and neonatal outcomes. In most centers the data regarding the rate of general anesthesia for cesarean section, the difficulty in performing neuraxial anesthesia, complications related to coagulation dysfunction and other complications, is limited.
In studies published by gynecologists or neonatologists, there is a significant lack of data relevant to the daily practice of anesthesiologists.
- Conditions
- Preeclampsia
- Keywords
- Obstetric Anesthesia, Anesthetic Management, Preeclampsia, Regional Anesthesia, Complication
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of Anesthesia
Final Type of Anesthesia for Cesarean Section including General or Regional Anesthesia
Measured: Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)
Secondary outcomes (11)
Perioperative anesthetic management
Different issues of perioperative anesthetic management including aspiration prophylaxis, airway management, induction, maintenance and emergence from anesthesia.
Perioperative anesthetic management issues including:
- Aspiration prophylaxis use: Yes/No; type of medication used.
- Airway management: Videolaryngoscopy use: Yes/No; number of attempts.
- Induction phase of anesthesia: type of antihypertensive medication, hypnotics, opiates, and neuromuscular blocking agent.
- Maintenance phase of anesthesia: type of volatile anesthetics, nitrous oxide or TIVA technique.
- Emergence phase of anesthesia: type of neuromuscular reversal agent.
Measured: Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days
Postoperative pain management
Postoperative pain management according to the visual analog scale (VAS) (0 - no pain to 10 - worst pain)
Measured: From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days
Invasive monitoring use
Invasive monitoring use during Cesarean Section
Measured: During surgery
Anesthetic complications
Description of Anesthetic complications
Measured: Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days
Admission to ICU unit
Admission to Intensive Care Unit (ICU) unit (Yes/No) and duration of admission (days)
Measured: Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days
Use of blood products
Type of blood product administered in perioperative period: RBC - Yes/No; FFP - Yes/No; PLT - Yes/No; CRYO - Yes/No.
Total amount of each blood product units administered during perioperative period.
Measured: Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days
Indication for surgery
Indication for Cesarean Section
Measured: Indication for Cesarean Section will be defined by obstetrician before the operation
Obstetric complications
Specific obstetric and maternal complications
Measured: Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days
Apgar score
Apgar score at 1 and 5 minutes. Apgar score was published by Virginia Apgar. Measured from 0 to 10. The maximum score is a 10, the lowest score is a 0. Scores a 7 or above is considered in good health, while scores under a 7 may require immediate medical care.
Measured: Will be defined at 1 and 5 minute after fetal delivery during surgery
Admission to NICU
Number of neonates that required admission to Neonatal Intensive Care Unit (NICU). According to decision of neonatologist that presented during the operation
Measured: Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days
Neonatal complications
Neonatal complications
Measured: Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Ioscovich, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237011
- Sponsor's protocol ID
- 0278-21-SZMC
- Status last verified
- Feb 2022
- First submitted
- 30 Dec 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siddiqui MM, Banayan JM, Hofer JE. Pre-eclampsia through the eyes of the obstetrician and anesthesiologist. Int J Obstet Anesth. 2019 Nov;40:140-148. doi: 10.1016/j.ijoa.2019.04.002. Epub 2019 Apr 13.
PubMed 31208869Hodgkinson R, Husain FJ, Hayashi RH. Systemic and pulmonary blood pressure during caesarean section in parturients with gestational hypertension. Can Anaesth Soc J. 1980 Jul;27(4):389-94. doi: 10.1007/BF03007461. No abstract available.
PubMed 7407669Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.
PubMed 33642943Lee LO, Bateman BT, Kheterpal S, Klumpner TT, Housey M, Aziz MF, Hand KW, MacEachern M, Goodier CG, Bernstein J, Bauer ME; Multicenter Perioperative Outcomes Group Investigators. Risk of Epidural Hematoma after Neuraxial Techniques in Thrombocytopenic Parturients: A Report from the Multicenter Perioperative Outcomes Group. Anesthesiology. 2017 Jun;126(6):1053-1063. doi: 10.1097/ALN.0000000000001630.
PubMed 28383323Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.
PubMed 21333604
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripartum Anesthetic Management of Patients With Preeclampsia: Prospective Cohort International Observational Study
- ClinicalTrials.gov ID
- NCT05237011
- Acronym / sponsor ID
- 0278-21-SZMC
- Conditions
- Preeclampsia
- Keywords
- Obstetric Anesthesia, Anesthetic Management, Preeclampsia, Regional Anesthesia, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 11 Feb 2022 (actual)
- 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 investigators will conduct a prospective, observational multicentral international study of perioperative management of patients with preeclampsia. The data will be collected from the maternity files and information systems of the medical centers including obstetric, anesthetic and neonatal parameters according to the attached Excel data table.
Results of the study will help to improve the management of patients with preeclampsia and will help to understand the nature and rate of complications. In addition, the study will help in comparing collected data to the data in the literature and as a result improve the safety of care and service that these patient receive in the institution.
Detailed description
In recent years, there has been a growing interest in anesthetic management of parturients diagnosed with preeclampsia.
The management of patients with preeclampsia is influenced by maternal conditions that include airway changes, coagulation dysfunction and significant hemodynamic changes.
Without changing regular practice the investigators will observe and collect data about: the type of anesthesia during surgery, perioperative monitoring and management of these patients (please see study outcomes). Complications reported in the literature include significant elevated blood pressure during laryngoscopy and development of intracranial hemorrhage, spinal/epidural bleeding during neuraxial anesthesia in patients with preeclampsia, and coagulation abnormalities.
Although the number of patients diagnosed with preeclampsia is estimated at five to ten percent of the general maternity population, there is a lack of prospective studies regarding the anesthetic management, obstetric complications and neonatal outcomes. In most centers the data regarding the rate of general anesthesia for cesarean section, the difficulty in performing neuraxial anesthesia, complications related to coagulation dysfunction and other complications, is limited.
In studies published by gynecologists or neonatologists, there is a significant lack of data relevant to the daily practice of anesthesiologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parturient with diagnosis of preeclampsia that delivered by cesarean section.
Key inclusion criteria (1 listed)
- Parturient with diagnosis of preeclampsia for Cesarean Section
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of Anesthesia
Time frame: Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)
Final Type of Anesthesia for Cesarean Section including General or Regional Anesthesia
11 secondary outcomes
Perioperative anesthetic management
Time frame: Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days
Postoperative pain management
Time frame: From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days
Invasive monitoring use
Time frame: During surgery
Anesthetic complications
Time frame: Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days
Admission to ICU unit
Time frame: Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days
Use of blood products
Time frame: Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days
Indication for surgery
Time frame: Indication for Cesarean Section will be defined by obstetrician before the operation
Obstetric complications
Time frame: Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days
Apgar score
Time frame: Will be defined at 1 and 5 minute after fetal delivery during surgery
Admission to NICU
Time frame: Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days
Neonatal complications
Time frame: Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 31208869Siddiqui MM, Banayan JM, Hofer JE. Pre-eclampsia through the eyes of the obstetrician and anesthesiologist. Int J Obstet Anesth. 2019 Nov;40:140-148. doi: 10.1016/j.ijoa.2019.04.002. Epub 2019 Apr 13.
- Background: PubMed 7407669Hodgkinson R, Husain FJ, Hayashi RH. Systemic and pulmonary blood pressure during caesarean section in parturients with gestational hypertension. Can Anaesth Soc J. 1980 Jul;27(4):389-94. doi: 10.1007/BF03007461. No abstract available.
- Background: PubMed 33642943Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.
- Background: PubMed 28383323Lee LO, Bateman BT, Kheterpal S, Klumpner TT, Housey M, Aziz MF, Hand KW, MacEachern M, Goodier CG, Bernstein J, Bauer ME; Multicenter Perioperative Outcomes Group Investigators. Risk of Epidural Hematoma after Neuraxial Techniques in Thrombocytopenic Parturients: A Report from the Multicenter Perioperative Outcomes Group. Anesthesiology. 2017 Jun;126(6):1053-1063. doi: 10.1097/ALN.0000000000001630.
- Background: PubMed 21333604Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18.
- Individual participant dataSharing planned: No
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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.
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 Shaare Zedek Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 11 Feb 2022. 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 Israel. 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 Alexander Ioscovich, M.D. (+972508685052, aioscovich@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of Anesthesia (time frame: Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237011, which also lists 5 linked publications.
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 11 Feb 2022.