Survey on Patients After Childbearth Following Bariatric Surgery

NCT04297956 | Completed

• 1 other identifier: spot_mom
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 5

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.

Conditions

Bariatric Surgery Status in Childbirth; Puerperal Depression

Outcome Measures

Primary Outcomes (3)

• Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview (SCID)

  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

  date of recruitement (> 6 months after childbirth)

• Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview

  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

  retrospective: time frame 0-4 weeks after birth

• Number of patients with prevalence of symptoms of depression assessed by structured clinical interview

  Prevalence of symptoms can be defined by scores that lead to diagnosis of psychiatric disorder in structured clinical interview

  retrospective: complete lifetime from date of birth until date of recruitment (> 6 months after childbirth), assessed up to 50 years

Secondary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients visiting the metabolic ambulance for follow-up care after bariatric surgery are eligible for the study.

You may qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (5)

University Hospital

Würzburg, Bavaria, 97080, Germany

Location

Sana Adipositaszentrum Offenbach

Offenbach, Hesse, 63069, Germany

Location

Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Sana Adipositaszentrum NRW

Remscheid, North Rhine-Westphalia, 42853, Germany

Location

Adipositaszentrum Westküstenklinium Heide

Heide, Schleswig-Holstein, 25746, Germany

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ann-Cathrin Koschker, Dr. med.

  Würzburg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of outpatient clinic for diabetes and lipids

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 6, 2020
• Study Start: February 5, 2020
• Primary Completion: February 15, 2023
• Study Completion: February 28, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

DE (5)