NCT02609217

Brief Summary

The aim of this study is to gain insight in the experiences and expectations of Belgian parents concerning primary cesarean section. This will be achieved by structured patient interviews and questionnaires in 24 women undergoing the procedure and their partners. This group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and their partners.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

November 10, 2015

Last Update Submit

April 7, 2016

Conditions

Keywords

electivecesarean

Outcome Measures

Primary Outcomes (1)

  • Information on parents' fears and expectations around cesarean section

    Information on parents' fears and expectations around cesarean section will be obtained using structured patient interviews and questionnaires.

    6 weeks post partum

Secondary Outcomes (5)

  • Quantitative data on postoperative pain after cesarean section

    6 weeks post partum

  • Data on the experience of postoperative pain after cesarean section

    6 weeks postpartum

  • Data on frequency of breastfeeding after cesarean section

    6 weeks postpartum

  • Qualitative data of breastfeeding after cesarean section

    6 weeks postpartum

  • Data on the experience of breastfeeding after cesarean section

    6 weeks postpartum

Study Arms (2)

Multiparous

12 multiparous women and their partners, planned to undergo elective term cesarean section.

Other: Questionnaires and interviews

Nulliparous

12 nulliparous women and their partners, planned to undergo elective term cesarean section.

Other: Questionnaires and interviews

Interventions

MultiparousNulliparous

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women planned to undergo term elective cesarean section selected from antenatal low-risk clinic.

You may qualify if:

  • Pregnant women
  • Partner available
  • years of age
  • Singleton pregnancy
  • Booked for planned cesarean section ≥37 weeks of gestation
  • Dutch-speaking
  • Informed consent given

You may not qualify if:

  • Emergency cesarean section
  • \<18 years of age or \>50 years of age
  • Multiple pregnancy
  • Inability to provide consent (language, etc.)
  • Partner not consenting
  • BMI \>35 kg/m2
  • Maternal or fetal pathologies expected to affect pre and postnatal maternal/neonatal management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations