Clinical trial NCT04297956: Survey on Patients After Childbearth Following Bariatric Surgery
Official title: Survey on Patients After Childbearth Following Bariatric Surgery - Data Collection on Mental Health Complications, Weight Change, Nutrition Deficiencies and Postpartal Progress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Status in Childbirth
Puerperal Depression
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting the metabolic ambulance for follow-up care after bariatric surgery are eligible for the study.

Brief summary: Women with a history of bariatric surgery may face various difficulties during pregnancy and puerperal time. Therefore it is assumed the prevalence of mental health disorders might be higher than in average women during and after pregnancy. This could possibly lead to an unsatisfying weight progress and therapeutic non-adherence. These factors shall be observed in the study in order to characterize this special cohort of participants.

Detailed description: Women following bariatric surgery are included at least 6 months after childbirth to evaluate retrospectively pregnancy and puerperal time. For mental health issues questionnaires, a structured clinical interview (SCID) and a psychological interview give an insight to past and present status. In order to evaluate weight progress and nutrient deficiencies routine follow-up care data of bariatric surgery is screened. In order to assess the course of pregnancy and child development data is extracted from pregnancy and child's examinations reports. Furthermore medication adherence, quality of life and sleep are registered by questionnaires.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* status following bariatric / metabolic surgery due to indication criteria
* childbirth after bariatric / metabolic surgery, at least 6 months ago
* written informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview (SCID)
timeFrame: date of recruitement (> 6 months after childbirth)
measure: Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview
timeFrame: retrospective: time frame 0-4 weeks after birth
measure: Number of patients with prevalence of symptoms of depression assessed by structured clinical interview
timeFrame: retrospective: complete lifetime from date of birth until date of recruitment (> 6 months after childbirth), assessed up to 50 years
Secondary outcomes:
measure: Mean change of body weight from baseline
timeFrame: from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years
measure: Status of nutritional deficiencies and therapy adherence
timeFrame: from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years
measure: Adverse events in pregnancy and child development
timeFrame: from date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 years
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital
state: Bavaria
city: Offenbach am Main
country: Germany
facility: Sana Adipositaszentrum Offenbach
state: Hessen
city: Aachen
country: Germany
facility: Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie
state: Nordrhein-Westfalen
city: Remscheid
country: Germany
facility: Sana Adipositaszentrum NRW
state: Nordrhein-Westfalen
city: Heide
country: Germany
facility: Adipositaszentrum Westküstenklinium Heide
state: Schleswig-Holstein
Study officials:
affiliation: Würzburg University Hospital
name: Ann-Cathrin Koschker, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: