NCT05396417

Brief Summary

Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local check-list for cesarean delivery.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

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

May 27, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 27, 2022

Last Update Submit

April 24, 2023

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • Level of adherence to the ERAS guidelines after elective or emergency cesarean delivery

    To which extent does the postoperative treatment of the parturients meet the ERAS criteria

    3 days post surgery

Study Arms (1)

Cesarean delivery

Any urgency any reason

Procedure: cesarean delivery

Interventions

cesarean deliveryPROCEDURE

Cesarean delivery under any form of anesthesia for any reason and for any indication

Cesarean delivery

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women undergoing cesarean delivery at the University of Helsinki central hospital/Women's hospital

You may qualify if:

  • Eligible for ERAS protocol cesarean delivery
  • Cesarean delivery for any indication
  • Any anesthesia method
  • Any urgency category

You may not qualify if:

  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUS/Women's hospital dept of obstetrics

Helsinki, 00029, Finland

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 27, 2022

First Posted

May 31, 2022

Study Start

January 1, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)