Peripartum Anesthetic Management of Patients With Preeclampsia

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05237011
• Other study ID #: 0278-21-SZMC
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2022
• Source: Shaare Zedek Medical Center
• Contact: Alexander Ioscovich, M.D.
• Phone: +972508685052
• Email: aioscovich[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parturient with diagnosis of preeclampsia for Cesarean Section

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Israel	Shaare Zedek Meedical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Hodgkinson 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. — View Citation

Hutcheon 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. Review. — View Citation

Lee 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. — View Citation

Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021 Feb 24:1-10. doi: 10.1007/s40140-021-00437-6. [Epub ahead of print] Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of Anesthesia	Final Type of Anesthesia for Cesarean Section including General or Regional Anesthesia	Final Type of Anesthesia will be defined during the Cesarean Section (during the operation)
Secondary	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.	Beginning from preoperative assessment by anesthesiologist to discharge from Post-Anesthesia Care Unit (PACU) / ICU (Intensive Care Unit) assessed up to 5 days
Secondary	Postoperative pain management	Postoperative pain management according to the visual analog scale (VAS) (0 - no pain to 10 - worst pain)	From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days
Secondary	Invasive monitoring use	Invasive monitoring use during Cesarean Section	During surgery
Secondary	Anesthetic complications	Description of Anesthetic complications	Anesthetic complications of patient as result of anesthetic management during the surgery until discharge from the hospital, assessed up to 5 days
Secondary	Admission to ICU unit	Admission to Intensive Care Unit (ICU) unit (Yes/No) and duration of admission (days)	Admission to during current hospitalization and until discharge from the hospital, assessed up to 5 days
Secondary	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.	Type and total amount of blood products that administered to patient during the surgery and during the hospitalization, assessed up to 5 days
Secondary	Indication for surgery	Indication for Cesarean Section	Indication for Cesarean Section will be defined by obstetrician before the operation
Secondary	Obstetric complications	Specific obstetric and maternal complications	Obstetric complications of patient during the surgery until discharge from the hospital, assessed up to 5 days
Secondary	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.	Will be defined at 1 and 5 minute after fetal delivery during surgery
Secondary	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	Admission to NICU unit during the surgery until maternal discharge from the hospital, assessed up to 5 days
Secondary	Neonatal complications	Neonatal complications	Neonatal complications during the surgery until maternal discharge from the hospital, assessed up to 5 days