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

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ClinicalTrials.gov Identifier: NCT01921465
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 18, 2016
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Iben Lorentzen, Herning Hospital

Brief Summary:
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 .

Condition or disease
Outpatient Care

Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ambulation time [ Time Frame: three days ]
    ambulation time measured during the first three days after delivery by an accelerometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
multiparas having a elective cesarean section at Herning hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921465


Locations
Denmark
Department of gynaecology and obstetrics, Herning Hospital
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
University of Aarhus
Investigators
Principal Investigator: Iben P Lorentzen, Midwife University of Aarhus

Responsible Party: Iben Lorentzen, Midwife, Herning Hospital
ClinicalTrials.gov Identifier: NCT01921465     History of Changes
Other Study ID Numbers: 1ILorentzen
outpatientcesareanlorentzen
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: February 2014

Keywords provided by Iben Lorentzen, Herning Hospital:
outpatient care
videoconferencing
elective cesarean section