Overview

This trial is active, not recruiting.

Condition cesarean section
Treatment questionnaires and interviews
Sponsor Universitaire Ziekenhuizen Leuven
Start date November 2015
End date May 2016
Trial size 24 participants
Trial identifier NCT02609217, 58593

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
12 multiparous women and their partners, planned to undergo elective term cesarean section.
questionnaires and interviews
12 nulliparous women and their partners, planned to undergo elective term cesarean section.
questionnaires and interviews

Primary Outcomes

Measure
Information on parents' fears and expectations around cesarean section
time frame: 6 weeks post partum

Secondary Outcomes

Measure
Quantitative data on postoperative pain after cesarean section
time frame: 6 weeks post partum
Data on the experience of postoperative pain after cesarean section
time frame: 6 weeks postpartum
Data on frequency of breastfeeding after cesarean section
time frame: 6 weeks postpartum
Qualitative data of breastfeeding after cesarean section
time frame: 6 weeks postpartum
Data on the experience of breastfeeding after cesarean section
time frame: 6 weeks postpartum

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Pregnant women - Partner available - 18-50 years of age - Singleton pregnancy - Booked for planned cesarean section ≥37 weeks of gestation - Dutch-speaking - Informed consent given Exclusion Criteria: - 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

Additional Information

Official title Parents' Expectations and Experiences Around Cesarean Section in Belgium
Description The subjects in both groups will be interviewed twice and will receive three questionnaires. One to two weeks prior to the scheduled cesarean section and during a scheduled obstetric outpatient visit, the first interview and questionnaire will be administered to the couple. A second questionnaire will be provided while still hospitalized (5 days post partum), to both mother and partner. Six weeks post partum, during a scheduled obstetric outpatient visit, the couple will be interviewed for the last time and will be asked to complete the third and last questionnaire.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.