Survey on Patients After Childbearth Following Bariatric Surgery

NCT ID: NCT04297956

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-05

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Bariatric Surgery Status in Childbirth Puerperal Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ann-Cathrin Koschker

Head of outpatient clinic for diabetes and lipids

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann-Cathrin Koschker, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Würzburg University Hospital

Locations

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University Hospital

Würzburg, Bavaria, Germany

Site Status

Sana Adipositaszentrum Offenbach

Offenbach, Hesse, Germany

Site Status

Uniklinikum Aachen, Klinik für Allgemein-, Viszeral-und Transplantationschirurgie

Aachen, North Rhine-Westphalia, Germany

Site Status

Sana Adipositaszentrum NRW

Remscheid, North Rhine-Westphalia, Germany

Site Status

Adipositaszentrum Westküstenklinium Heide

Heide, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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spot_mom

Identifier Type: -

Identifier Source: org_study_id

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