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Completed

NCT Number: NCT04297956

Survey on Patients After Childbearth Following Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Status in Childbirth Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Depression Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital, Würzburg, Bavaria, Germany

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: SPOtMom

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2020
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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