Trial document




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  DRKS00017065

Trial Description

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Title

Prevention network Western Pomerania: Mental and neurobiological health in pregnant women and young mothers

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Trial Acronym

PriVileG-M

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URL of the Trial

https://www.uni-greifswald.de/universitaet/information/aktuelles/detail/n/praeventionsstudie-zu-stress-und-sorgen-waehrend-der-schwangerschaft-und-nach-der-geburt-43743/

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Brief Summary in Lay Language

PriVileG-M is a scientific pilot study conducted in Western Pomerania and it is designed to focus on pregnant women. We want to support the expectant mothers in reducing their own and their infants stress level. Furthermore we want to assist the participants in building a stable relationship with their child, reacting more self-confindent in conflicts and strengthen their self-competence.
The duration of the study is approximately 16 months. A total of five study assessments are planned with consultation/psychological support, filling in questionnaires, extraction of biological samples (for example blood and saliva), video recording, internet survey of the partners.



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Brief Summary in Scientific Language

Background: As early as pregnancy, maternal mental stress impinge on the child development and health. Thus, this may cause an enhanced risk for premature birth, lowered fetal growth, and lower fetal birth weight as well as enhanced levels of the stress hormone cortisol and lowered levels of the bonding hormone oxytocin. Maternal stress further reduces maternal sensitivity for the child’s needs which impairs the mother-child-interaction and bonding. Therefore, prevention and intervention studies are necessary that focus on mentally stressed parents begin in prepartum and apply rigorous research methodology, such as randomized controlled trials, to ensure high validity.
Methods: A sequentially randomized controlled trial is used to assess the impact of psychotherapy and telemedicine on maternal mental stress and the child’s mental and physical health. Mentally stressed pregnant women are randomized to an intervention (IG) and a not intervened control group (CG). The IG receives an individualized psychotherapy starting prepartum and lasting for 10 months. Afterwards, a second randomization is used to investigate whether the use of telemedicine can stabilize the therapeutic effects. Using ambulatory assessments and video recording, the transfer into daily life, the maternal sensitivity and the mother-child-bonding are assessed. Psycho-biologically, the synchronicity of cortisol and oxytocin levels between mother and child are assessed. The peptidome of the colostrum and breast milk, which are assumed to be essential for the adaptation of the child to the extra-uterine environment, is investigated. Moreover, an internet survey of the partners will be implemented (baseline, 8 weeks, 26 weeks, 52 weeks) to assess their influence on child development und maternal health.
All assessments made are compared with the assessments of healthy women. Finally, the results of the study will lead to the development of a qualification measure for health professionals who will be trained to detect mental stress, to treat it with low-level interventions and to refer those women with high stress levels to professional institutions
Discussion: The study aims to prevent the transgenerational transfer of psychiatric and somatic disorders from the mother to her child. The effects of the psychotherapy will be stabilized through telemedicine and long-term impacts on the child’s and mothers’ mental health are enhanced. The combination of psychotherapy, telemedicine and the methodologies of ambulatory assessment, video recording and biobanking are new in content-related and methodological manner.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

The study results will be released to the scientific public by conferences and
international peer-reviewed impact journals as well as to the general public
by presentations in health care organizations and national congresses. The
study results will also contribute to the development of a qualification measure informing nurses, midwifes, pediatricians and mental healthcare practitioners about low-level interventions for stressed pregnant and postpartum
women.
The datasets generated during the current study are available from the
corresponding author on reasonable request.

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Organizational Data

  •   DRKS00017065
  •   2019/05/02
  •   [---]*
  •   yes
  •   Approved
  •   BB 012/19, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  •   U1111-1230-9826 
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Health Condition or Problem studied

  •   prenatal und postnatal maternal mental and physical health
  •   prenatal und postnatal mental and physical health of the offspring
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Interventions/Observational Groups

  •   1. control group: mentally stable women
  •   2. control group: mentally stressed women without intervention
  •   Mentally stressed women with psychotherapeutic intervention and following telemedical intervention (psychotherapeutic Intervention from the end of the 2nd trimester until 26 weeks postpartal; telemedical intervention from week 26 postpartal until 52 weeks postpartal)
  •   Mentally stressed women with psychotherapeutic intervention without subsequent telemedical intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Concerning the women, interventions are expected to reduce mental stress (assessed by the BSI-18 to screening, baseline and 8-week, 26-week and 52-week follow-ups)

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Secondary Outcome

(1) concerning the women
i. to improve quality of life
ii. to enhance resilience
iii. to increase rates of breastfeeding mothers

(2) Concerning the children, interventions are expected
i. to reduce rates of preterm birth as well as complications during childbirth
ii. to reduce regulation disorders
iii. to reduce developmental retardations
iv. to strengthen physical health

(3) Concerning women and children, interventions are expected
i. to improve mother-child-interaction and to strengthen bonding (MAAS, PBQ, CARE Index)
ii. to lower cortisol levels and to increase oxytocin levels in both mother and child
The outcomes (1) to (3) are expected to converge to those of healthy mothers and children in the control group. In contrast, it is assumed that these outcomes depart in the group of stressed women without intervention from those of the intervention group.

(4) In addition, the results of the study will lead to the development of a qualification measure for health professionals who will be trained to detect mental stress, and in turn to refer those women to professional institutions.

The study aims to examine by explorative analysis hormonal transmissions between mother and child. Therefore, a biobank will be built up to analyse DNS-sequences, RNA-expression, miRNA as well as DNA methylation and other metabolomics. In particular, the study scrutinizes how the development of the HPA-axis in infants is shaped by depressive symptoms of the mother and how the HPA-axis in mother and infants is influenced by the different interventions of the study. Moreover, the constituents of breast milk will be analyzed, as well as hormonal responses of mother and child to stress.
Quantitative and qualitative analysis of the subjective satisfaction of the woman as well as of the efficacy and feasability of the intervention study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/05/19
  •   240
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   17   Years
  •   45   Years
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Additional Inclusion Criteria

Pregnant women are included if they are between 18 and 45 years of age and at the end of the second pregnancy trimester (25th to 29th week of pregnancy).

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Exclusion Criteria

Women with multiple pregnancies or foreseeable developmental disabilities of the fetus, as well as women requiring withdrawal, exhibiting low motivation for therapy, suffering alcohol or drug addiction (DIPS), having severe psychosis or reporting suicidality (DIPS) need to be excluded. In addition, women being submitted to a recent psychiatric or psychotherapeutic treatment (or another study including such treatments) have to be excluded in order to impede confounding of therapeutic effects. Women who are 17 years old at the screenings, can be included, but will be excluded if they won't reach the age of 18 at delivery.

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Addresses

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    • Universitätsmedizin Greifswald, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr.  Hans  Grabe 
    • Ellernholtzstraße 1-2
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr.  Hans  Grabe 
    • Ellernholzstraße 1-2
    • 17489  Greifswald
    • Germany
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    • Universität Greifswald, Institut für Psychologie Lehrstuhl Gesundheit und Prävention
    • Ms.  Prof. Dr.  Silke  Schmidt 
    • Robert-Blum-Straße 13
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald, Neonatologie und Pädiatrische Intensivmedizin
    • Mr.  Prof. Dr.  Matthias  Heckmann 
    • Ferdinand-Sauerbruch-Straße
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
    • Mr.  Prof. Dr.  Marek  Zygmunt 
    • Ferdinand-Sauerbruch-Straße
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald, Institut für Community Medicine / Abt. Versorgungsepidemiologie und Community Health
    • Ms.  PD Dr.  Neeltje  Van den Berg 
    • Ellernholzstr. 1-2
    • 17489  Greifswald
    • Germany
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    • Hochschule Neubrandenburg, Pflegewissenschaft/Ambulante Dienste
    • Ms.  Prof. Dr.  Bedriska  Bethke 
    • Brodaer Straße 2
    • 17033  Neubrandenburg
    • Germany
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    • Universitätsmedizin Greifswald, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Ms.  Juliane  Corleis 
    • Walther-Rathenau-Str. 43-45
    • 17489  Greifswald
    • Germany
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    • Universitätsmedizin Greifswald, Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Ms.  Juliane  Corleis 
    • Walther-Rathenau-Str. 43-45
    • 17489  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Landesamt für Gesundheit und Soziales M-V
    • E.-Schlesinger-Straße 35
    • 18059  Rostock
    • Germany
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    •   0381
    •   [---]*
    •   [---]*
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    • Ministerium für Arbeit, Gleichstellung und Soziales M-VReferat 540 "ESF-Fondsverwaltung/-steuerung"
    • Mr.  Eberhard  Messmann 
    • Werderstraße 124
    • 19055  Schwerin
    • Germany
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    •   0385 5889540
    •   eberhard.messmann@sm.mv-regierung.de
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.