Survey on Patients After Childbearth Following Bariatric Surgery (SPOtMom)

April 23, 2024 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

Conditions

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

  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • University Hospital
    • Hessen
      • Offenbach am Main, Hessen, Germany, 63069
        • Sana Adipositaszentrum Offenbach
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie
      • Remscheid, Nordrhein-Westfalen, Germany, 42853
        • Sana Adipositaszentrum NRW
    • Schleswig-Holstein
      • Heide, Schleswig-Holstein, Germany, 25746
        • Adipositaszentrum Westküstenklinium Heide

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:

  • 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
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
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

Wuerzburg University Hospital

Investigators

  • Principal Investigator: Ann-Cathrin Koschker, Dr. med., Würzburg University Hospital

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)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

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.

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