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Survey on Patients After Childbearth Following Bariatric Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04297956
Acronym
SPOtMom
Enrollment
36
Registered
2020-03-06
Start date
2020-02-05
Completion date
2023-02-28
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Status in Childbirth, Puerperal Depression

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.

Interventions

None listed

Sponsors

Wuerzburg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

\-

Design outcomes

Primary

MeasureTime frameDescription
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 interviewretrospective: time frame 0-4 weeks after birthquestionnaires 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
Number of patients with prevalence of symptoms of depression assessed by structured clinical interviewretrospective: complete lifetime from date of birth until date of recruitment (> 6 months after childbirth), assessed up to 50 yearsPrevalence of symptoms can be defined by scores that lead to diagnosis of psychiatric disorder in structured clinical interview

Secondary

MeasureTime frameDescription
Mean change of body weight from baselinefrom date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 yearsBody weight is measured on scales and participants are asked additionally via questionnaire. Baseline measurement starts at date of bariatric surgery.
Status of nutritional deficiencies and therapy adherencefrom date of bariatric surgery until date of recruitment (> 6 months after childbirth), assessed up to 20 yearsParticipants 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.
Adverse events in pregnancy and child developmentfrom date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 yearsRecord of prenatal care and record of child's examinations are screened for complications.

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORAnn-Cathrin Koschker, Dr. med.

Würzburg University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026