NCT05237011

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

December 30, 2021

Last Update Submit

February 2, 2022

Conditions

Preeclampsia

Keywords

Obstetric AnesthesiaAnesthetic ManagementPreeclampsiaRegional AnesthesiaComplication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Perioperative anesthetic management

    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

    From the start of surgery to the end of postoperative care in recovery unit assessed up to 5 days

  • Invasive monitoring use

    During surgery

  • Anesthetic complications

    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 during current hospitalization and until discharge from the hospital, assessed up to 5 days

  • +6 more secondary outcomes

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parturient with diagnosis of preeclampsia that delivered by cesarean section.

You may qualify if:

  • Parturient with diagnosis of preeclampsia for Cesarean Section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Meedical Center

Jerusalem, Israel

Location

Related Publications (5)

  • 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.

    PMID: 31208869BACKGROUND

  • 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. doi: 10.1007/BF03007461. No abstract available.

    PMID: 7407669BACKGROUND

  • Ring 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.

    PMID: 33642943BACKGROUND

  • 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.

    PMID: 28383323BACKGROUND

  • 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.

    PMID: 21333604BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Alexander Ioscovich, M.D.

CONTACT

+972508685052aioscovich@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Obstetric Anesthesia Unit

Study Record Dates

First Submitted

December 30, 2021

First Posted

February 11, 2022

Study Start

February 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)