Skip to content

Peripartum Anesthetic Management of Patients With Preeclampsia

Peripartum Anesthetic Management of Patients With Preeclampsia: Prospective Cohort International Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05237011
Enrollment
1500
Registered
2022-02-11
Start date
2022-02-01
Completion date
2023-01-01
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Obstetric Anesthesia, Anesthetic Management, Preeclampsia, Regional Anesthesia, Complication

Brief 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 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.

Interventions

None listed

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Parturient with diagnosis of preeclampsia for Cesarean Section

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Type of AnesthesiaFinal 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

Secondary

MeasureTime frameDescription
Postoperative pain managementFrom the start of surgery to the end of postoperative care in recovery unit assessed up to 5 daysPostoperative pain management according to the visual analog scale (VAS) (0 - no pain to 10 - worst pain)
Invasive monitoring useDuring surgeryInvasive monitoring use during Cesarean Section
Anesthetic complicationsAnesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 daysDescription of Anesthetic complications
Admission to ICU unitAdmission to during current hospitalization and until discharge from the hospital, assessed up to 5 daysAdmission to Intensive Care Unit (ICU) unit (Yes/No) and duration of admission (days)
Use of blood productsType and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 daysType 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.
Perioperative anesthetic managementBeginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 daysDifferent issues of perioperative anesthetic management including aspiration prophylaxis, airway management, induction, maintenance and emergence from anesthesia. Perioperative anesthetic management issues including: 1. Aspiration prophylaxis use: Yes/No; type of medication used. 2. Airway management: Videolaryngoscopy use: Yes/No; number of attempts. 3. Induction phase of anesthesia: type of antihypertensive medication, hypnotics, opiates, and neuromuscular blocking agent. 4. Maintenance phase of anesthesia: type of volatile anesthetics, nitrous oxide or TIVA technique. 5. Emergence phase of anesthesia: type of neuromuscular reversal agent.
Obstetric complicationsObstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 daysSpecific obstetric and maternal complications
Apgar scoreWill be defined at 1 and 5 minute after fetal delivery during surgeryApgar 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.
Admission to NICUAdmission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 daysNumber of neonates that required admission to Neonatal Intensive Care Unit (NICU). According to decision of neonatologist that presented during the operation
Neonatal complicationsNeonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 daysNeonatal complications
Indication for surgeryIndication for Cesarean Section will be defined by obstetrician before the operationIndication for Cesarean Section

Countries

Israel

Contacts

Primary ContactAlexander Ioscovich, M.D.
aioscovich@gmail.com+972508685052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026