NCT04815044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4.4 years

First QC Date

March 22, 2021

Last Update Submit

September 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Experiences of bodily changes in pregnancy and post-partum period

    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

    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

    Questionnaire rating (Likert scale 0, don't agree - 5, totaly agree) different aspects in the prenatal care service

    January 2021 - December 2026

Secondary Outcomes (11)

  • Current symptoms of eating disorders

    January 2021 - December 2026

  • Current symptoms of depression

    January 2021 - December 2026

  • Planning of pregnancy

    January 2021 - December 2026

  • Help in becoming pregnant

    January 2021 - December 2026

  • Supplementation and drugs during pregnancy

    January 2021 - December 2026

  • +6 more secondary outcomes

Other Outcomes (3)

  • Exercise in pregnancy, frequency

    January 2021 - December 2026

  • Exercise in pregnancy, intensity

    January 2021 - December 2026

  • Exercise in pregnancy, activity type

    January 2021 - December 2026

Study Arms (1)

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.

Other: PregnancyOther: Post-Partum

Interventions

Experiences from being pregnant when having a history of eating disorder

Women from the PED-t study

Experiences from the post-partum period when having a history of eating disorder

Women from the PED-t study

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • not matching the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therese Fostervold Mathisen

Fredrikstad, Fredrikstad, 1671, Norway

Location

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia NervosaBinge-Eating DisorderDepression, Postpartum

Interventions

PregnancyPostpartum Period

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Therese F Mathisen, PhD

    Østfold University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

December 1, 2020

Primary Completion

April 8, 2025

Study Completion

April 8, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data will be held within the research group

Locations