Fast-track Discharge After Elective Cesarean Section

Postoperative Period Clinical Trial

Official title:

Fast-track Discharge After Elective Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911727
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2020
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Period

Intervention

Procedure:
• Fast-track discharge
As described above

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynecology	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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