Fast-track Discharge After Elective Cesarean Section

NCT ID: NCT02911727

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fast-track discharge

Intervention Type PROCEDURE

As described above

Standard discharge

Discharge at least 48 hours after elective cesarean section.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fast-track discharge

As described above

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Herning Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Kruse

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Byrjalsen, MD

Role: STUDY_CHAIR

Department chairman

Locations

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Department of Obstetrics and Gynecology

Herning, , Denmark

Site Status

Countries

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Denmark

References

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Jones E, Stewart F, Taylor B, Davis PG, Brown SJ. Early postnatal discharge from hospital for healthy mothers and term infants. Cochrane Database Syst Rev. 2021 Jun 8;6(6):CD002958. doi: 10.1002/14651858.CD002958.pub2.

Reference Type DERIVED
PMID: 34100558 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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