Fast-track Discharge After Elective Cesarean Section

Study Overview
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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.

Official Title
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Fast-track Discharge After Elective Cesarean Section

Conditions
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Postoperative Period

Intervention / Treatment
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* Procedure: Fast-track discharge


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast-track discharge<br>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<br>* As described above<br>|
| No Intervention: Standard discharge<br>Discharge at least 48 hours after elective cesarean section. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Postnatal Care