Fast-track Discharge After Elective Cesarean Section

Not Applicable

Completed

• Conditions: Postoperative Period
• Interventions: Procedure: Fast-track discharge

• Registration Number: NCT02911727
• Lead Sponsor: Herning Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Study Start: 2016-10
• Primary Completion: 2019-12-31
• Status Verified: 2020-05
• Study Completion: 2020-05-31
• Last Update Submitted: 2020-05-31
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fast-track discharge	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.

Primary Outcome Measures

Name	Time	Method
Parents' Postnatal Sense of Security	Measured one week after delivery	Using the validated PPSS-questionaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology; 🇩🇰 Herning, Denmark