Trial document




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  DRKS00012854

Trial Description

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Title

Effects of the birthing room environment on vaginal births and client-centred outcomes in women at term planning a vaginal birth: a multicentre RCT

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Trial Acronym

BE-UP

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URL of the Trial

https://be-up-studie.de/english-summary/

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Brief Summary in Lay Language

Background: Research indicates that by changing the hospital birth environment, maternal self-determination during labour will be facilitated. A pilot study by Hodnett 2009 indicates that a redesigned birthing room, which fosters maternal mobility, relaxation, coping with pain, self-determination and personal comfort, may help to increase the rate of vaginal births.
Thus the study will answer the question whether women who aim at a normal birth and who labour in a redesigned birthing room will be more likely to have a normal birth (compared with controls), have less medical interventions, less complications, better health, and are more satisfied with their birth experience.
Methods: In 12 hospitals 4,000 women will be assigned by chance to one of two parallel trial groups: either the intervention or the control group. The intervention birthing room will be environmentally redesigned: the delivery bed won't be visible, and there will be equipment that facilitates mobility, coping with pain, self-determination. The control birthing room will be a typical birthing room with a delivery bed which is centrally positioned. Professionals will care for the women according to hospital standards.
Data will be documented during labour and after birth. The women will fill in questionnaires on the postpartum unit and at 3 months after birth. Additionally, a cost analysis will be done.

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Brief Summary in Scientific Language

Aim: This multicentre RCT tests the effect of a redesigned birthing room (intervention) on the probability of vaginal birth (VB) in 12 obstetric units (hospitals). So far there is no RCT, which was adequately powered, to study the independent effect of the birthing environment. By increasing VB, the rate of caesarean sections will be reduced, which in Germany is higher than recommended by the WHO and associated with increased maternal and infant morbidity. This trial is in line with the recently proclaimed German national health goal “Health in Childbirth” (Gesundheit rund um die Geburt).
Design: Active controlled superiority trial; two-arm parallel design; birthing room with special design features (intervention) which are absent in the control birthing room; independent centrally controlled and concealed randomisation; no blinding possible; data verification by external monitors; 3 months follow-up; power: 90%, significance level: 5%, dropout rate: <10%; health economic evaluation.
Subjects: Primiparae and multiparae with a singleton fetus in cephalic presentation at term planning a VB.
Expected outcome: An increase of VB by 5% from baseline of 72% (nationally 421,241 VB in hospitals) to 77% would result in an additional 21,062 women per year, who experience a VB instead of a CS. Expected benefits are improved physical/emotional client-centred outcomes, more self-determination during birth, less medical interventions, less subsequent CS in future pregnancies, less health care costs for interventions.
On 7 June 2018, the responsible ethics committee was informed of the change in the statistically calculated planned number of random samples from 4,000 to 3,800 participants. The calculation is based on the current perinatal data of the participating clinics for 2017.

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Organizational Data

  •   DRKS00012854
  •   2018/03/07
  •   [---]*
  •   yes
  •   Approved
  •   2017-140, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  •   U1111-1204-0964 
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Health Condition or Problem studied

  •   Vaginal birth
  •   O80 -  Single spontaneous delivery
  •   O81 -  Single delivery by forceps and vacuum extractor
  •   O82 -  Single delivery by caesarean section
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Interventions/Observational Groups

  •   A room in which a delivery bed is absent or concealed, with materials (such as a beanbag, a set of table and chairs, and audiovisuals, floor lamp...) that support the woman’s upright body positions, mobility, and relaxation.
  •   Usual birthing room with a delivery bed which is centrally positioned and accessible from 3 sides; other equipment (e.g. birthing stool, cloth...) need not be removed.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Probability of a vaginal birth.

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Secondary Outcome

Maternal self-determination during birth (assessed by validated questionnaire LAS) at 3 months postpartum; incidence of episiotomy, of 3rd & 4th degree perineal tears, epidural analgesia as well as “critical outcome of newborn at term” (composite indicator).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/04/02
  •   3800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   37   Weeks of pregnancy
  •   41   Weeks of pregnancy
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Additional Inclusion Criteria

Primiparae and multiparae of all ages, a singleton cephalic presentation, gestation between 37+0 weeks to 41+6 weeks, an intended VB, and an active 1st stage.

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Exclusion Criteria

Wish for water birth, active 2nd stage, emergency, pathological (definition according to FIGO) fetal heart tracings on admission, indications for caesarean section (CS) according to the NICE guideline, and limited capability to understand written and oral German.

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Addresses

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    • Martin-Luther-Universität Halle-Wittenberg, Institut für Gesundheits- und Pflegewissenschaft,
    • Ms.  Dr. rer. medic.  Gertrud M.  Ayerle 
    • Magdeburger Str. 8,
    • 06112  Halle (Saale),
    • Germany
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    • Hochschule für Gesundheit,
    • Ms.  Prof. Dr.  Rainhild  Schäfers 
    • Gesundheitscampus 6-8,
    • 44801  Bochum,
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg, Institut für Gesundheits- und Pflegewissenschaft
    • Ms.  Dr. rer. medic.  Gertrud M.  Ayerle 
    • Magdeburger Str. 8,
    • 06112  Halle (Saale),
    • Germany
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    • Martin-Luther-Universität Halle-Wittenberg, Institut für Gesundheits- und Pflegewissenschaft,
    • Ms.  Dipl. med. päd.  Sabine  Striebich 
    • Magdeburger Str. 8,
    • 06112  Halle (Saale),
    • Germany
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    • Hochschule für Gesundheit,
    • Ms.  M.Sc.  Elke  Mattern 
    • Gesundheitscampus 6-8,
    • 44801  Bochum,
    • Germany
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    • Hochschule für Gesundheit,
    • Ms.  M.A.  Theresa  Oganowski 
    • Gesundheitscampus 6-8,
    • 44801  Bochum,
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministeriums für Bildung und Forschung (BMBF),
    • Kapelle-Ufer 1,
    • 10117  Berlin,
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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