Outpatient Care for Multiparas After Elective Cesarean Section: an Observational Study

August 16, 2016 updated by: Iben Lorentzen, Herning Hospital
The purpose of the study is to evaluate whether outpatient cesarean section can be performed in multiparous women without significant decrease in the parents' sense of security .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Herning, Denmark, 7400
        • Department of gynaecology and obstetrics, Herning Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

multiparas having a elective cesarean section at Herning hospital

Description

Inclusion Criteria:

  • Planned elective cesarean section of multiparous women
  • Singleton pregnancy
  • Age of at least 18
  • Gestational age between 37 and 42 weeks
  • Internet access at home

Exclusion Criteria:

  • Lack of consent
  • Women with no or little understanding of Danish and ability to speak Danish.
  • Allergies to medicine included in the pain management regimes
  • Expected maternal or neonatal complications after delivery
  • Birth weight of less than 2500 grams

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
multiparas having a planned cesarean section
elective cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the parents' postnatal sense of security (PPSS)
Time Frame: the PPSS is measured the second week after delivery
measured by a questionnaire sent to the parents' in the second week after delivery.
the PPSS is measured the second week after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ambulation time
Time Frame: three days
ambulation time measured during the first three days after delivery by an accelerometer
three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Iben P Lorentzen, Midwife, University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

February 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 1ILorentzen
  • outpatientcesareanlorentzen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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