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

Outpatient Care Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921465
• Other study ID #: 1ILorentzen
• Secondary ID: outpatientcesare
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: August 16, 2016
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: February 2014
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Outpatient Care

Locations

Country	Name	City	State
Denmark	Department of gynaecology and obstetrics, Herning Hospital	Herning

Sponsors (2)

Lead Sponsor	Collaborator
Herning Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	ambulation time	ambulation time measured during the first three days after delivery by an accelerometer	three days	No