Pregnancy RelatedPREG_PED-tNCT04815044
Experiences From Pregnancy and Post-partum Period in Women With a History of Eating Disorders.
An observational study of Pregnancy Related and Eating Disorders, run by Ostfold University College at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related, Eating Disorders, Bulimia Nervosa
- What is being tested?
- Pregnancy and Post-Partum
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2020to 8 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- not matching the above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related, Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder, Post Partum Depression
- Being tested
- Pregnancy, Post-Partum
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregnancyOther
Experiences from being pregnant when having a history of eating disorder
Post-PartumOther
Experiences from the post-partum period when having a history of eating disorder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pregnancy; Other: Post-Partum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: January 2021 - December 2026
Secondary outcomes (11)
Current symptoms of eating disorders
Measuring current symptoms of eating disorders at time of interview. Using the eating disorder examination questionnaire by Fairburn.
Measured: January 2021 - December 2026
Current symptoms of depression
Measuring current symptoms of depression at time of interview. Using the Beck Depression inventory.
Measured: January 2021 - December 2026
Planning of pregnancy
Number of pregnancy that was (un)planned, and whether the female was using hormonal contraceptives at time of conception.
Measured: January 2021 - December 2026
Help in becoming pregnant
Number of women in need of fertility assistance/treatment
Measured: January 2021 - December 2026
Supplementation and drugs during pregnancy
Number of women who regularly consumed tobacco/were smoking, drank alcohol, or used prescribed drugs during pregnancy
Measured: January 2021 - December 2026
Body weight during pregnancy
Change in body weight during pregnancy
Measured: January 2021 - December 2026
Blood pressure in pregnancy
Change in blood pressure during pregnancy
Measured: January 2021 - December 2026
Fetus heart rate
Change in fetus heart rate during pregnancy
Measured: January 2021 - December 2026
Symphysis measure
Change in symphysis measure during pregnancy
Measured: January 2021 - December 2026
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)
Measured: January 2021 - December 2026
Birth delivery method
Frequency of different birth delivery methods
Measured: January 2021 - December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Dec 2020
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, University of Tromso
- Responsible party
- Principal investigator, Therese Fostervold Mathisen, Ostfold University College
- Investigators
- Therese F Mathisen, PhD, Principal investigator, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815044
- Sponsor's protocol ID
- 120532
- Acronym
- PREG_PED-t
- Status last verified
- Sep 2025
- First submitted
- 22 Mar 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be held within the research group
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences From Pregnancy and Post-partum Period, and Health Outcomes for Mother and Child, in Women With a History of Eating Disorders.
- ClinicalTrials.gov ID
- NCT04815044
- Acronym / sponsor ID
- PREG_PED-t / 120532
- Conditions
- Pregnancy Related, Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder, Post Partum Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, University of Tromso
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women from the PED-t study | – | Other: Pregnancy, Other: Post-PartumWomen who participated in the PED-t study in 2016-2018 who report previous (or in future time) pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- not matching the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregnancyExperiences from being pregnant when having a history of eating disorder | Other | Women from the PED-t study |
| Post-PartumExperiences from the post-partum period when having a history of eating disorder | Other | Women from the PED-t study |
Primary outcome
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)
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)
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
11 secondary outcomes
Current symptoms of eating disorders
Time frame: January 2021 - December 2026
Current symptoms of depression
Time frame: January 2021 - December 2026
Planning of pregnancy
Time frame: January 2021 - December 2026
Help in becoming pregnant
Time frame: January 2021 - December 2026
Supplementation and drugs during pregnancy
Time frame: January 2021 - December 2026
Body weight during pregnancy
Time frame: January 2021 - December 2026
Blood pressure in pregnancy
Time frame: January 2021 - December 2026
Fetus heart rate
Time frame: January 2021 - December 2026
Symphysis measure
Time frame: January 2021 - December 2026
Frequency and type of pregnancy complication
Time frame: January 2021 - December 2026
Birth delivery method
Time frame: January 2021 - December 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No. Data will be held within the research group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese F Mathisen, PhD principal investigator
Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Eating Disorders, run by Ostfold University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences of bodily changes in pregnancy and post-partum period (time frame: January 2021 - December 2026). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.