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

Pregnancy Related Clinical Trial

— PREG_PED-t  

Official title:

Experiences From Pregnancy and Post-partum Period, and Health Outcomes for Mother and Child, in Women With a History of Eating Disorders.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04815044
• Other study ID #: 120532
• Status: Enrolling by invitation
• Start date: December 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Ostfold University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Depression, Postpartum
• Eating Disorders
• Feeding and Eating Disorders
• Post Partum Depression
• Pregnancy Related

Intervention

Other:
• Pregnancy
Experiences from being pregnant when having a history of eating disorder
• Post-Partum
Experiences from the post-partum period when having a history of eating disorder

Locations

Country	Name	City	State
Norway	Therese Fostervold Mathisen	Fredrikstad

Sponsors (3)

Lead Sponsor	Collaborator
Ostfold University College	Norwegian School of Sport Sciences, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise in pregnancy, frequency	Change in exercise frequency during pregnancy	January 2021 - December 2026
Other	Exercise in pregnancy, intensity	Change in exercise intensity during pregnancy	January 2021 - December 2026
Other	Exercise in pregnancy, activity type	Type of physical activity during pregnancy	January 2021 - December 2026
Primary	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
Primary	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
Primary	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	Current symptoms of eating disorders	Measuring current symptoms of eating disorders at time of interview. Using the eating disorder examination questionnaire by Fairburn.	January 2021 - December 2026
Secondary	Current symptoms of depression	Measuring current symptoms of depression at time of interview. Using the Beck Depression inventory.	January 2021 - December 2026
Secondary	Planning of pregnancy	Number of pregnancy that was (un)planned, and whether the female was using hormonal contraceptives at time of conception.	January 2021 - December 2026
Secondary	Help in becoming pregnant	Number of women in need of fertility assistance/treatment	January 2021 - December 2026
Secondary	Supplementation and drugs during pregnancy	Number of women who regularly consumed tobacco/were smoking, drank alcohol, or used prescribed drugs during pregnancy	January 2021 - December 2026
Secondary	Body weight during pregnancy	Change in body weight during pregnancy	January 2021 - December 2026
Secondary	Blood pressure in pregnancy	Change in blood pressure during pregnancy	January 2021 - December 2026
Secondary	Fetus heart rate	Change in fetus heart rate during pregnancy	January 2021 - December 2026
Secondary	Symphysis measure	Change in symphysis measure during pregnancy	January 2021 - December 2026
Secondary	Frequency and type of pregnancy complication	Numbers experiences different pregnancy complications (chosing from a list of alternatives: abortion, bleedings, edema, gestational diabetes, preeclampsia, pelvic pain)	January 2021 - December 2026
Secondary	Birth delivery method	Frequency of different birth delivery methods	January 2021 - December 2026