Fast-track Discharge After Elective Cesarean Section

May 31, 2020 updated by: Anne Kruse, Herning Hospital

Cesarean section (CS) is a procedure with prolonged hospital stay compared to the routine for normal vaginal delivery in multiparas. The difference is caused mainly by postoperative pain but improvements in management of pain may change this situation and make early discharge possible. However, several aspects need to be considered.

The aim of this project is to evaluate fast-track discharge for multiparas after elective CS concerning neonatal and maternal complications as well as the parents' sense of security and well-being.

The study is a randomized controlled trial including 142 women allocated to either 1) the intention to discharge within 28 hours followed by a home visit or 2) standard discharge after at least 48 hours after elective CS.

This study will be among the first evaluating fast-track discharge after CS in a European context. If a positive outcome is achieved, we expect that fast-track discharge can be implemented with improved quality and reduced costs in postnatal care following elective CS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Planned elective CS of multiparous women
  • Singleton pregnancy
  • Gestational age at least 37+0 weeks
  • Prepregnancy BMI <35

Exclusion Criteria:

  • Lack of consent
  • Women with no or little understanding of and ability to speak Danish
  • Expected maternal or neonatal complications after delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast-track discharge
Intention to discharge within 28 hours after elective cesarean section including a home visit by a nurse or midwife from the postnatal ward.
Procedure: Fast-track discharge
As described above
No Intervention: Standard discharge
Discharge at least 48 hours after elective cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' Postnatal Sense of Security
Time Frame: Measured one week after delivery
Using the validated PPSS-questionaire
Measured one week after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: During the first week postpartum
Measured by the patient in a questionnaire using numeric rating scale
During the first week postpartum
Use of analgesia
Time Frame: During the first week postpartum
Daily consumption in mg of paracetamol, NSAID and opioid.
During the first week postpartum
Mobilization
Time Frame: 5 days postpartum
Step count measured by an activity monitor (Fitbit Flex)
5 days postpartum
Breastfeeding
Time Frame: 6 months after delivery
Duration and extent of breastfeeding
6 months after delivery
Readmissions
Time Frame: 28 days postpartum
Number of readmissions and length of hospital stay in number of days
28 days postpartum
Surgical complications
Time Frame: 28 days postpartum
Number of complications using the Clavien-Dindo Classification (1-5)
28 days postpartum
Complications in the postnatal period
Time Frame: 28 days postpartum
Number and type of complications using the ICD-10 classification
28 days postpartum
Contacts to the health care system
Time Frame: 28 days postpartum
Number of contacts and site of contacts (primary or secondary care)
28 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herning Hospital

Investigators

  • Study Chair: Byrjalsen, MD, Department chairman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 31, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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