- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815044
Experiences From Pregnancy and Post-partum Period in Women With a History of Eating Disorders. (PREG_PED-t)
Experiences From Pregnancy and Post-partum Period, and Health Outcomes for Mother and Child, in Women With a History of Eating Disorders.
Women with the eating disorder bulimia nervosa (BN) have been found to have a higher risk of unplanned pregnancies than healthy women, and experience greater miscarriage, premature birth, birth complications, and postpartum depression. Other studies have found that women with eating disorders seem to find motivation to refrain from the eating disordered behavior for the sake of the fetus, but that it is highly different whether this gives sustained or only a temporary remission.
Eating disorders are rarely detected in the primary health care service, nor during pregnancy or during follow-up in fertility clinics. Meeting a health care provider in the pregnancy care service who does not know about the eating disorder or who does not understand the disease well enough, can also make the management and experience of pregnancy and weight gain extra difficult.
The aim of this study is to increase the knowledge on how women with a history of eating disorder experience their bodily changes, and how they experience the health service in pregnancy care and post-partum period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Women with the eating disorder bulimia nervosa (BN) have been found to have a higher risk of unplanned pregnancies than healthy women, and experience greater miscarriage, premature birth, birth complications, and postpartum depression. Having a disorder in which the overevaluation of the need to control body weight and food intake is pertinent, may cause a tremendous mental challenge to accept the bodily change through a pregnancy. Other studies have found that women with eating disorders seem to find motivation to refrain from the eating disordered behavior for the sake of the fetus, but that it is highly different whether this gives sustained or only a temporary remission.
Eating disorders are rarely detected in the primary health care service, nor during pregnancy or during follow-up in fertility clinics. Meeting a health care provider in the pregnancy care service who does not know about the eating disorder or who does not understand the disease well enough, can also make the management and experience of pregnancy and weight gain extra difficult.
The aim of this study is to increase the knowledge on how women with a hisory of eating disorders experience bodily changes through pregnancy, and how the pregnancy care service is experienced. The purpose of this data collection is to help design preparatory information for women with eating disorders who become pregnant, and to promote best practice guidelines for the health service in the meeting with, and follow-up of, pregnant women with a history of eating disorders.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Fredrikstad, Norway, 1671
- Therese Fostervold Mathisen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- previous participant in the PED-t project
- previous/current diagnosis of bulimia nervosa or binge eating disorder
- has accepted to take part in the long-term follow up study in the PED-t project
- has been/are pregnant
Exclusion Criteria:
- not matching the above criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Women from the PED-t study
Women who participated in the PED-t study in 2016-2018 who report previous (or in future time) pregnancy.
|
Experiences from being pregnant when having a history of eating disorder
Experiences from the post-partum period when having a history of eating disorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiences of bodily changes in pregnancy and post-partum period
Time Frame: January 2021 - December 2026
|
What are the experiences of bodily changes in pregnancy and post-partum period in women with a history of eating disorders?
(semistructured interviews)
|
January 2021 - December 2026
|
Experiences with pregnancy health care- and post-partum service
Time Frame: January 2021 - December 2026
|
What are the experiences of pregnancy health care service in women with a history of eating disorders?
(semistructured interviews)
|
January 2021 - December 2026
|
Quality of prenatal care
Time Frame: January 2021 - December 2026
|
Questionnaire rating (Likert scale 0, don't agree - 5, totaly agree) different aspects in the prenatal care service
|
January 2021 - December 2026
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Current symptoms of eating disorders
Time Frame: January 2021 - December 2026
|
Measuring current symptoms of eating disorders at time of interview.
Using the eating disorder examination questionnaire by Fairburn.
|
January 2021 - December 2026
|
Current symptoms of depression
Time Frame: January 2021 - December 2026
|
Measuring current symptoms of depression at time of interview.
Using the Beck Depression inventory.
|
January 2021 - December 2026
|
Planning of pregnancy
Time Frame: January 2021 - December 2026
|
Number of pregnancy that was (un)planned, and whether the female was using hormonal contraceptives at time of conception.
|
January 2021 - December 2026
|
Help in becoming pregnant
Time Frame: January 2021 - December 2026
|
Number of women in need of fertility assistance/treatment
|
January 2021 - December 2026
|
Supplementation and drugs during pregnancy
Time Frame: January 2021 - December 2026
|
Number of women who regularly consumed tobacco/were smoking, drank alcohol, or used prescribed drugs during pregnancy
|
January 2021 - December 2026
|
Body weight during pregnancy
Time Frame: January 2021 - December 2026
|
Change in body weight during pregnancy
|
January 2021 - December 2026
|
Blood pressure in pregnancy
Time Frame: January 2021 - December 2026
|
Change in blood pressure during pregnancy
|
January 2021 - December 2026
|
Fetus heart rate
Time Frame: January 2021 - December 2026
|
Change in fetus heart rate during pregnancy
|
January 2021 - December 2026
|
Symphysis measure
Time Frame: January 2021 - December 2026
|
Change in symphysis measure during pregnancy
|
January 2021 - December 2026
|
Frequency and type of pregnancy complication
Time Frame: January 2021 - December 2026
|
Numbers experiences different pregnancy complications (chosing from a list of alternatives: abortion, bleedings, edema, gestational diabetes, preeclampsia, pelvic pain)
|
January 2021 - December 2026
|
Birth delivery method
Time Frame: January 2021 - December 2026
|
Frequency of different birth delivery methods
|
January 2021 - December 2026
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise in pregnancy, frequency
Time Frame: January 2021 - December 2026
|
Change in exercise frequency during pregnancy
|
January 2021 - December 2026
|
Exercise in pregnancy, intensity
Time Frame: January 2021 - December 2026
|
Change in exercise intensity during pregnancy
|
January 2021 - December 2026
|
Exercise in pregnancy, activity type
Time Frame: January 2021 - December 2026
|
Type of physical activity during pregnancy
|
January 2021 - December 2026
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120532
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Binge-Eating Disorder
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
-
ShireCompleted
-
Lindner Center of HOPEUniversity of CincinnatiCompleted
-
Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
-
Nova Scotia Health AuthorityCompletedBinge-Eating Disorder | Eating DisorderCanada
-
University of Southern CaliforniaNot yet recruitingBinge-Eating Disorder
-
Alexandria UniversityActive, not recruitingBinge Eating DisorderEgypt
-
Heidelberg UniversitySelfapy GmbHCompleted
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedBinge-Eating DisorderUnited States
-
Nova Scotia Health AuthorityCompletedBinge Eating DisorderCanada
Clinical Trials on Pregnancy
-
SPD Development Company LimitedIllingworth Research LtdCompleted
-
Michigan State UniversityMichigan Department of Community HealthCompleted
-
University of Southern DenmarkRegion of Southern Denmark; OPEN; Lida og Oskar Nielsens Fond; Esbjerg Fonden; Gangsted...Completed
-
University of California, San FranciscoActive, not recruitingUnintended Pregnancy | Undesired PregnancyUnited States
-
Caixia LiuNot yet recruitingPregnancy Weight of Twin Pregnancy
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...University of Padova; Mount Sinai Hospital, Canada; Istituto Oncologico Veneto... and other collaboratorsRecruitingPregnancy Complications | Pregnancy Loss | Desmoid | Desmoid; AbdominalUnited States, Canada, France, Italy
-
Carlos III Health InstituteMerck Sharp & Dohme LLC; Red Temática de Investigación Cooperativa en SidaUnknownHIV Infections | Pregnancy Related
-
University of OxfordRecruitingCardiovascular Diseases | Vascular Diseases | Cerebrovascular Disorders | HypertensionUnited Kingdom
-
University of OxfordThe George InstituteCompletedAnemia | Pre-Eclampsia | Gestational DiabetesIndia
-
Assisting NatureUnknown