Outpatient Care for Multiparas After Elective Cesarean Se... | NCT01921465

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

NCT01921465

Sponsor

Herning Hospital

Status

Completed

Last Update Posted

Aug 18, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Outpatient Care

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
outpatientcesareanlorentzen

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Aug 9, 2013

First Submission Date that Met QC Criteria

Aug 12, 2013

First Posted Date

Aug 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2016

Last Update Posted Date

Aug 18, 2016Estimated

Name	Class
University of Aarhus	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
multiparas having a planned cesarean section		elective cesarean section

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

multiparas having a elective cesarean section at Herning hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iben P Lorentzen, Midwife	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of gynaecology and obstetrics, Herning Hospital		Herning	Herning	7400	Denmark