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Completed

NCT Number: NCT02911727

Fast-track Discharge After Elective Cesarean Section

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.

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Key information

Conditions

Postoperative Period

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology

Herning, 7400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast-track discharge

Procedure

As described above

Primary outcomes

  1. Parents' Postnatal Sense of Security

    Time frame: Measured one week after delivery

    Using the validated PPSS-questionaire

Secondary outcomes

  1. Pain scores

    Time frame: During the first week postpartum

    Measured by the patient in a questionnaire using numeric rating scale

  2. Use of analgesia

    Time frame: During the first week postpartum

    Daily consumption in mg of paracetamol, NSAID and opioid.

  3. Mobilization

    Time frame: 5 days postpartum

    Step count measured by an activity monitor (Fitbit Flex)

  4. Breastfeeding

    Time frame: 6 months after delivery

    Duration and extent of breastfeeding

  5. Readmissions

    Time frame: 28 days postpartum

    Number of readmissions and length of hospital stay in number of days

  6. Surgical complications

    Time frame: 28 days postpartum

    Number of complications using the Clavien-Dindo Classification (1-5)

  7. Complications in the postnatal period

    Time frame: 28 days postpartum

    Number and type of complications using the ICD-10 classification

  8. Contacts to the health care system

    Time frame: 28 days postpartum

    Number of contacts and site of contacts (primary or secondary care)

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 22, 2016
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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