Clinical trial NCT04815044: Experiences From Pregnancy and Post-partum Period in Women With a History of Eating Disorders.
Official title: Experiences From Pregnancy and Post-partum Period, and Health Outcomes for Mother and Child, in Women With a History of Eating Disorders.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pregnancy Related
Eating Disorders
Bulimia Nervosa
Binge-Eating Disorder
Post Partum Depression
Lead sponsor: Ostfold University College
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
name: University of Tromso
First posted: 2021-03-24
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Qualifying women are those who during 2016-2018 participated in the treatment project "PED-t", in which women with bulimia nervosa or binge eating disorder received PED-t or cogntive behavior therapy as treatment for their eating disorder.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Experiences of bodily changes in pregnancy and post-partum period
timeFrame: January 2021 - December 2026
measure: Experiences with pregnancy health care- and post-partum service
timeFrame: January 2021 - December 2026
measure: Quality of prenatal care
timeFrame: January 2021 - December 2026
Secondary outcomes:
measure: Current symptoms of eating disorders
timeFrame: January 2021 - December 2026
measure: Current symptoms of depression
timeFrame: January 2021 - December 2026
measure: Planning of pregnancy
timeFrame: January 2021 - December 2026
measure: Help in becoming pregnant
timeFrame: January 2021 - December 2026
measure: Supplementation and drugs during pregnancy
timeFrame: January 2021 - December 2026
measure: Body weight during pregnancy
timeFrame: January 2021 - December 2026
measure: Blood pressure in pregnancy
timeFrame: January 2021 - December 2026
measure: Fetus heart rate
timeFrame: January 2021 - December 2026
measure: Symphysis measure
timeFrame: January 2021 - December 2026
measure: Frequency and type of pregnancy complication
timeFrame: January 2021 - December 2026
measure: Birth delivery method
timeFrame: January 2021 - December 2026
Other outcomes:
measure: Exercise in pregnancy, frequency
timeFrame: January 2021 - December 2026
measure: Exercise in pregnancy, intensity
timeFrame: January 2021 - December 2026
measure: Exercise in pregnancy, activity type
timeFrame: January 2021 - December 2026
Locations:
city: Fredrikstad
country: Norway
facility: Therese Fostervold Mathisen
Study officials:
affiliation: Østfold University College
name: Therese F Mathisen, PhD
role: PRINCIPAL_INVESTIGATOR
References: