NCT02911727

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 2, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

3.2 years

First QC Date

September 2, 2016

Last Update Submit

May 31, 2020

Conditions

Postoperative Period

Keywords

Cesarean sectionPostnatal Care

Outcome Measures

Primary Outcomes (1)

  • Parents' Postnatal Sense of Security

    Using the validated PPSS-questionaire

    Measured one week after delivery

Secondary Outcomes (8)

  • Pain scores

    During the first week postpartum

  • Use of analgesia

    During the first week postpartum

  • Mobilization

    5 days postpartum

  • Breastfeeding

    6 months after delivery

  • Readmissions

    28 days postpartum

  • +3 more secondary outcomes

Study Arms (2)

Fast-track discharge

EXPERIMENTAL

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

Standard discharge

NO INTERVENTION

Discharge at least 48 hours after elective cesarean section.

Interventions

Fast-track dischargePROCEDURE

As described above

Fast-track discharge

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology

Herning, 7400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34100558DERIVED

Study Officials

  • Byrjalsen, MD

    Department chairman

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 22, 2016

Study Start

October 1, 2016

Primary Completion

December 31, 2019

Study Completion

May 31, 2020

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations

DK(1)