Survey on Patients After Childbearth Following Bariatric Surgery

Bariatric Surgery Status in Childbirth Clinical Trial

— SPOtMom  

Official title:

Survey on Patients After Childbearth Following Bariatric Surgery - Data Collection on Mental Health Complications, Weight Change, Nutrition Deficiencies and Postpartal Progress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297956
• Other study ID #: spot_mom
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2024
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2023
• Est. primary completion date: February 15, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Bariatric Surgery Status in Childbirth
• Depression, Postpartum
• Puerperal Depression

Locations

Country	Name	City	State
Germany	Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie	Aachen	Nordrhein-Westfalen
Germany	Adipositaszentrum Westküstenklinium Heide	Heide	Schleswig-Holstein
Germany	Sana Adipositaszentrum Offenbach	Offenbach am Main	Hessen
Germany	Sana Adipositaszentrum NRW	Remscheid	Nordrhein-Westfalen
Germany	University Hospital	Würzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	Mean change of body weight from baseline	Body weight is measured on scales and participants are asked additionally via questionnaire. Baseline measurement starts at date of bariatric surgery.	from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years
Secondary	Status of nutritional deficiencies and therapy adherence	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.	from date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 years
Secondary	Adverse events in pregnancy and child development	Record of prenatal care and record of child's examinations are screened for complications.	from date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 years