Experiences From Pregnancy and Post-partum Period in Women With a History of Eating Disorders. (PREG_PED-t)

April 18, 2022 updated by: Therese Fostervold Mathisen, Ostfold University College

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

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

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Fredrikstad, Norway, 1671
        • Therese Fostervold Mathisen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be held within the research group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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