Survey on Patients After Childbearth Following Bariatric Surgery (SPOtMom)
August 24, 2026 updated by: Ann-Cathrin Koschker, Wuerzburg University Hospital
Survey on Patients After Childbearth Following Bariatric Surgery - Data Collection on Mental Health Complications, Weight Change, Nutrition Deficiencies and Postpartal Progress
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bavaria
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Würzburg, Bavaria, Germany, 97080
- University Hospital
-
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Hesse
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Offenbach, Hesse, Germany, 63069
- Sana Adipositaszentrum Offenbach
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North Rhine-Westphalia
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Aachen, North Rhine-Westphalia, Germany, 52074
- Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie
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Remscheid, North Rhine-Westphalia, Germany, 42853
- Sana Adipositaszentrum NRW
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Schleswig-Holstein
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Heide, Schleswig-Holstein, Germany, 25746
- Adipositaszentrum Westküstenklinium Heide
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Patients visiting the metabolic ambulance for follow-up care after bariatric surgery are eligible for the study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with prevalence of symptoms of depression or anxiety assessed by questionnaires and structured clinical interview (SCID)
Time Frame: date of recruitement (> 6 months after childbirth)
|
questionnaires for depression:
questionnaire for anxiety:
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
Time Frame: retrospective: time frame 0-4 weeks after birth
|
questionnaires for depression:
questionnaire for anxiety:
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
Time Frame: 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
|
retrospective: complete lifetime from date of birth until date of recruitment (> 6 months after childbirth), assessed up to 50 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change of body weight from baseline
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
from date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann-Cathrin Koschker, Dr. med., Würzburg University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2020
Primary Completion (Actual)
February 15, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
February 24, 2020
First Submitted That Met QC Criteria
March 3, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 24, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- spot_mom
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.