Bariatric Surgery Status in ChildbirthSPOtMomNCT04297956
Survey on Patients After Childbearth Following Bariatric Surgery
An observational study of Bariatric Surgery Status in Childbirth and Puerperal Depression, run by Wuerzburg University Hospital at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bariatric Surgery Status in Childbirth, Puerperal Depression
- How many people
- 36 participants
- Where
- 5 sitesGermany
- Study dates
- 5 Feb 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients visiting the metabolic ambulance for follow-up care after bariatric surgery are eligible for the study.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie
Aachen, North Rhine-Westphalia, 52074
Adipositaszentrum Westküstenklinium Heide
Heide, Schleswig-Holstein, 25746
Sana Adipositaszentrum Offenbach
Offenbach, Hesse, 63069
Sana Adipositaszentrum NRW
Remscheid, North Rhine-Westphalia, 42853
University Hospital
Würzburg, Bavaria, 97080
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Body weight is measured on scales and participants are asked additionally via questionnaire. Baseline measurement starts at date of bariatric surgery.
Measured: 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
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.
Measured: 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
Record of prenatal care and record of child's examinations are screened for complications.
Measured: from date of beginning of pregnancy until date of recruitment (> 6 months after childbirth), assessed up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start5 Feb 2020
- Primary completion15 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery Status in ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann-Cathrin Koschker, Wuerzburg University Hospital
- Investigators
- Ann-Cathrin Koschker, Dr. med., Principal investigator, Würzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297956
- Sponsor's protocol ID
- spot_mom
- Acronym
- SPOtMom
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Plank U, Wehrmann K, Oehlhof F, Teske E, Stier C, Seyfried F, Buchholz W, Warrings B, Fassnacht M, Kubler A, Koschker AC. Mental Health After Childbirth in Women with Previous Bariatric Surgery: The SPOtMom Pilot Study. Exp Clin Endocrinol Diabetes. 2025 Mar;133(3):112-119. doi: 10.1055/a-2515-3240. Epub 2025 Mar 12.
PubMed 40073878
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Patients After Childbearth Following Bariatric Surgery - Data Collection on Mental Health Complications, Weight Change, Nutrition Deficiencies and Postpartal Progress
- ClinicalTrials.gov ID
- NCT04297956
- Acronym / sponsor ID
- SPOtMom / spot_mom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the metabolic ambulance for follow-up care after bariatric surgery are eligible for the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: * 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
Time frame: 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
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Results publication: PubMed 40073878Plank U, Wehrmann K, Oehlhof F, Teske E, Stier C, Seyfried F, Buchholz W, Warrings B, Fassnacht M, Kubler A, Koschker AC. Mental Health After Childbirth in Women with Previous Bariatric Surgery: The SPOtMom Pilot Study. Exp Clin Endocrinol Diabetes. 2025 Mar;133(3):112-119. doi: 10.1055/a-2515-3240. Epub 2025 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Cathrin Koschker, Dr. med. principal investigator
Würzburg University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Status in Childbirth and Puerperal Depression, run by Wuerzburg University Hospital at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.