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NCT04550364

MUMMIBODIES. Eating Disorders, Pregnancy and Post Partum Period.

Completed Results posted Last updated 2 May 2025
What this trial tests

trial in Mental Health Disorder in 24 participants. Completed in 11 February 2022.

Timeline
20 May 2020
Primary endpoint
31 January 2022
11 February 2022

Quick facts

Lead sponsorBente Sommerfeldt
StatusCompleted
Study typeOBSERVATIONAL
Enrollment24
Start date20 May 2020
Primary completion31 January 2022
Estimated completion11 February 2022
Sites1 location across Norway

Conditions studied

Sponsor

Bente Sommerfeldt

Who can join

Adults 20 to 40, female only, with Mental Health Disorder or Eating Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Each Type of Personal Features Associated With Worsening or Relapse of Eating Disorder Symptoms During Pregnancy (Time Point 1) Primary · During pregnancy, Interview between week 9 and week 40.

How do women with a history of eating disorders experience being pregnant? How do they understand and describe worsening and relapse and perceived triggers in such eventual changes? Delivery: Categorization, characterization, identification of possible dimensions and experiential descriptions of assumed critical, typical and atypical experiences. Ideal type analysis indicate seven different personal features associated with worsening or relapse: chaotic, rigid, perfect, worried, shameful, motherhood fearing and lost identity. Perceived triggers of worsening or relapse were: loss of control, un

The chaotic mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder5
The rigid mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder3
the perfect mother to be
GroupValue95% CI
Pregnant Women With a History of Eating Disorder3
The worried mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder4
the shameful mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder4
The mother who fears motherhood
GroupValue95% CI
Pregnant Women With a History of Eating Disorder3
The mother with the lost identity
GroupValue95% CI
Pregnant Women With a History of Eating Disorder6
Core Experiences Among 7 Women With a History of Severe Eating Disorders That Have Gone Through IVF-induced Pregnancy and Become Mothers. Time Point 1 and 2 for 7 Participants. Primary · Two time points is summed together and included both. interview timepoints (interview between week 9 and week 40 during pregnancy and Postpartum, on average 4-6 months following birth).

How do women with a history of severe eating disorders who have undergone IVF experience the process of becoming a mother through IVF, pregnancy and the postpartum period? The two time points are summed together in core experiences from pregnancy to brith and after birth. There were four core phenomena that were reported that were strikingly similar across all participants: "anxiousness and fear", "Shame and guilt", "sexual aladjustment" and "Non-disclosure of eating problems".

Anxiousness and fear
GroupValue95% CI
Pregnant Women With a History of Eating Disorder7
Shame and guilt
GroupValue95% CI
Pregnant Women With a History of Eating Disorder7
Sexual maladjustment
GroupValue95% CI
Pregnant Women With a History of Eating Disorder7
Non-disclosure of eating problems
GroupValue95% CI
Pregnant Women With a History of Eating Disorder7
Trajectories of Severe Eating Disorders Through Pregnancy and Early Motherhood.Number of Participants in Different Trajectories Associated With Symptoms of Eating Disorder Primary · Through study completion, an average of 14 months. Both time points (During pregnancy between week 9 and 40. Postpartum, on average 4-6 months following birth) were summed up in five trajectories from pregnancy to postpartum.

This study was based on interviews conducted with 24 participants during both pregnancy and postpartum. Additionaly, both diagnostic descriptions (DSM 5) and self-report (EDE-Q) were reported at both time points (Pregnancy and postpartum). How they experienced pregnancy and postpartum were summed up in five different trajectories. How do women with a history of severe ED experience their ED pathology during the process from pregnancy to postpartum? Is it possible to identify trajectories through pregnancy and early motherhood? Delivery: Empirically based hypothetical model for prototypical pr

The succeeding mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder4
The inadequate. mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder7
The depressed mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder10
The overwhelmed mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder6
The mastering mother
GroupValue95% CI
Pregnant Women With a History of Eating Disorder3
Eating Disorder Symptoms Reported Through Self Report EDE-Q. Secondary · Mean scores collected during pregnancy and postpartum

EDE-Q is a self-report measures to screen for eating disorders. Clinical cutoff scores for self-report measures on EDE-Q provide a means of evaluating clinically significant pathology. A cutoff above 2.7 on the total score has been recommended to screen for eating disorders. Higher values represent higher symptoms. The total score is a average on the four subscales. To obtain a score on each subscale, the items that fall under the individual subscale are added and the sum is divided by the number of items. To obtain the total score, the 4 subscale scores are summed and the total is divided by

EDE-Q mean score time point 1 during pregnancy
GroupValue95% CI
Pregnant Women With a History of Eating Disorder3.541.5 – 5.1
EDE-Q mean score. time point 2. postpartum. Above 2.7 ED diagnosis.
GroupValue95% CI
Pregnant Women With a History of Eating Disorder3.410.25 – 5.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 months. Two time points for each participant: During pregnancy and between 4-6 months after birth. From two to one group of participants that were interviewed at two time points: Pregnancy and postpartum. There were sufficint pregnant women that were recruited, and this made it possible to follow the same group of women longitudinal. No one were recrutied to the other group at this time.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pregnant Women With a History of Eating Disorder
Serious: 0/24 (0%)
Deaths: 0/24
Other adverse events (1 terms — click to expand)

ReactionSystemPregnant Women With a Hist…
Use of contingency planPsychiatric disorders

Data from ClinicalTrials.gov NCT04550364 adverse events section.

Sponsor's own description

MUMMIEBODIES is a research study when women with eating disorders encounter pregnancy, childbirth and postpartum. These are some condensed months that represent major challenges for this group. There are both a scientific and clinical basis for the mother's mental health to influence care and interaction with the child. In the case of eating disorders, there is also a risk of harmful consequences for the fetus as well as for more complicated pregnancies and births. This is a very important field of knowledge, but also a field about which there is far too little scientific knowledge. There is too little scientific knowledge about how women with eating disorders physically and mentally relate to their bodies and food during and after pregnancy. There is a great need for research that promotes expertise in how to help and meet women with eating disorders in these important phases of life. The aim of the study is to bring out the users' experiences. The investigators interview face-to-face pregnant women and mothers with eating disorders about their subjective experiences both during pregnancy and during childbirth. Recruitment of participants will be via health stations. The investigators will identify the course, experiences and solutions when women with eating disorders encounter pregnancy, childbirth and postpartum. The investigators focus on three themes: 1) experience of course and change, 2) experience of emotional, cognitive and relational core experiences, and 3) women's own perceptions of what is the best help. The three themes have in common that they are fundamental for later development of help for this vulnerable group. The investigators have a clear idea that some of the best preventive work can be done before life really starts.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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