NCT01921465

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 18, 2016

Status Verified

February 1, 2014

Enrollment Period

8 months

First QC Date

August 9, 2013

Last Update Submit

August 16, 2016

Conditions

Outpatient Care

Keywords

outpatient carevideoconferencingelective cesarean section

Outcome Measures

Primary Outcomes (1)

  • the parents' postnatal sense of security (PPSS)

    measured by a questionnaire sent to the parents' in the second week after delivery.

    the PPSS is measured the second week after delivery

Secondary Outcomes (1)

  • ambulation time

    three days

Study Arms (1)

multiparas having a planned cesarean section

elective cesarean section

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

multiparas having a elective cesarean section at Herning hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of gynaecology and obstetrics, Herning Hospital

Herning, Herning, 7400, Denmark

Location

Study Officials

  • Iben P Lorentzen, Midwife

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 13, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 18, 2016

Record last verified: 2014-02

Locations

DK(1)