Survey on Patients After Childbearth Following Bariatric Surgery

Completed

• Conditions: Puerperal Depression; Bariatric Surgery Status in Childbirth

• Registration Number: NCT04297956
• Lead Sponsor: Wuerzburg University Hospital

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.

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-06
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with prevalence of symptoms of depression assessed by structured clinical interview	retrospective: complete lifetime from date of birth until date of recruitment (> 6 months after childbirth), assessed up to 50 years	Prevalence of symptoms can be defined by scores that lead to diagnosis of psychiatric disorder in structured clinical interview
Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview (SCID)	date of recruitement (> 6 months after childbirth)	questionnaires for depression: * Beck Depression Inventory (BDI-II); * Patient Health Questionnaire-9 (PHQ-9); * Edinburgh Postnatal Depression Scale (EPDS); questionnaire for anxiety: * Generalized Anxiety Disorder-7 (GAD-7); Prevalence of symptoms can be defined by scores higher than defined cut-offs in questionnaires or scores that lead to diagnosis of psychiatric disorder in structured clinical interview
Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview	retrospective: time frame 0-4 weeks after birth	questionnaires for depression: * Patient Health Questionnaire-9 (PHQ-9); questionnaire for anxiety: * Generalized Anxiety Disorder-7 (GAD-7); Prevalence of symptoms can be defined by scores higher than defined cut-offs in questionnaires or scores that lead to diagnosis of psychiatric disorder in structured clinical interview

Secondary Outcome Measures

Name	Time	Method
Mean change of body weight from baseline	from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years	Body weight is measured on scales and participants are asked additionally via questionnaire. Baseline measurement starts at date of bariatric surgery.
Adverse events in pregnancy and child development	from date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 years	Record of prenatal care and record of child's examinations are screened for complications.
Status of nutritional deficiencies and therapy adherence	from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years	Participants are asked to answer Medication Adherence Report Scale (MARS-D) and blood levels concerning nutrients that are examined routinely in bariatric surgery follow-up care are analysed.

Trial Locations

Locations (5)

Sana Adipositaszentrum NRW; 🇩🇪 Remscheid, Nordrhein-Westfalen, Germany

Sana Adipositaszentrum Offenbach; 🇩🇪 Offenbach am Main, Hessen, Germany

Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany

Adipositaszentrum Westküstenklinium Heide; 🇩🇪 Heide, Schleswig-Holstein, Germany

University Hospital; 🇩🇪 Würzburg, Bavaria, Germany