We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

NewPreBP: Project Newborn -Preparation for Birth and Parenthood (NewPreBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01672437
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

The Danish regions aim to implement antenatal education in small groups for all expectant parents. The effects of general antenatal education for childbirth or parenthood, or both, remain largely unknown. Also it is unknown if antenatal education in small groups is superior to antenatal lectures which is currently standard care.

The aim of the trial is to evaluate if antenatal birth and parent preparation in small groups can increase parenting resources thereby easing birth and creating a smoother and less stressful transition to parenthood among the participants, compared to those allocated to standard care. This in turn is hypothesized to improve health and thriving among newborn families and affect their use of healthcare services. A thorough process evaluation will be conducted highlighting enabling factors and barriers to the implementation. Finally cost-effectiveness analysis will be conducted.

Individually randomised trial sited at Hvidovre Hospital, a large birth clinic in the Copenhagen Capital Region of Denmark.

Participants: 1756 pregnant women ≥ 18 years old, recruited before 20+0 weeks gestation, due to give birth at Hvidovre Hospital. Being legally able and willing to provide signed consent, and being fluent in Danish.

Women are randomised to receive:

  1. A research-based birth and parenting program. The intervention consists of 4 sessions in small groups that last for 2,5 hours per session at 25, 33 and 35 weeks of gestation, and a post-natal session 5 weeks after expected due date.
  2. Standard care (control group). The pregnant woman and her partner are offered two antenatal lectures in an auditorium.

The allocation of participants to the intervention will be 1:1 to the intervention and the control group.

Data will be collected via questionnaires at baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum and 1 year post-partum, via the hospital obstetric database, and via the national registers. Analyses will be intention to treat. Subgroup analysis will be conducted in relation to personal and demographic characteristics. Process evaluation will be conducted using questionnaires and qualitative interviews. The incremental societal cost of the intervention will be computed and compared to the measured outcomes in a cost-effectiveness analysis.

Outcomes: Stress, parenting alliance, depressive symptoms, wellbeing obstetric intervention, use of health care services, self-efficacy, divorce.

Condition or disease Intervention/treatment
Stress Depression Communication Self-efficacy Coping Other: Birth and parent preparation

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1766 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: NewPreBP: Project Newborn -Preparation for Birth and Parenthood. A Large Interdisciplinary Randomised Trial on the Effect of Birth and Parent Preparation
Study Start Date : November 2012
Primary Completion Date : September 2014
Study Completion Date : September 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Birth and parent preparation

The following subjects will be covered in the sessions:

Session 1 (25 weeks gestation):

  • Common challenges in the transition to parenthood and in the relationship
  • Couple communication

Session 2 (33 weeks gestation):

  • Expectations in relation to birth
  • The normal course of labour
  • Obstetric intervention
  • Pain relief,coping strategies
  • Partner support

Session 3 (35 weeks gestation):

  • Feeding a newborn
  • Interpreting the newborn's signs, symptoms and behaviour
  • Taking care of a newborn
  • Mood swings, postnatal depressive symptomatology

Session 4 (5 weeks post-partum):

  • Birth experiences
  • Mood swings, postnatal depressive symptomatology
  • The first time at home with a newborn
  • Couplehood - partner support, communication, division of household tasks
Other: Birth and parent preparation
4 sessions of birth and parent preparation in small groups of 6-8 couples. 3 sessions during pregnancy, 1 session following birth.
No Intervention: control group
The control group are offered two lectures in an auditorium during pregnancy - one on breastfeeding and one on labour. This is standard care.

Outcome Measures

Primary Outcome Measures :
  1. Epidural use [ Time Frame: during labour ]
    Epidural use during will be measured using data from the hospital obstetric database

Secondary Outcome Measures :
  1. Perceived stress [ Time Frame: baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum, 1 year post-partum ]
    The perceived stress scale (PSS) will be used to measure global levels of perceived stress. The PSS takes into account the individual's ability to cope. The scale was developed on the basis of appraisal theory and was designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading.

  2. Parenting stress [ Time Frame: 9 weeks post-partum, 6 months post-partum, 1 year post-partum ]
    Parenting stress will be measured using the Swedish Parenthood Stress Questionnaire (SPSQ) translated into Danish. The scale takes into account the individual's ability to cope and assesses parental stress with a sum score and subscale scores of incompetence, role restriction, social isolation, spouse relationship and health problems

  3. Parenting alliance [ Time Frame: 6 months post-partum, 1 year post-partum ]
    Parenting alliance will be measured by the Parenting Alliance Measure

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Expectant pregnant women (and partners)
  • ≥ 18 years old
  • Due to give birth at Hvidovre Hospital, Denmark
  • Able to speak and understand Danish
  • Being legally able and willing to provide signed consent

Exclusion Criteria:

  • Not providing signed informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672437

Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Vibeke Koushede
Copenhagen Trial Unit, Center for Clinical Intervention Research
Danish Cancer Society
Study Director: Pernille Due, MD University of Southern Denmark
Principal Investigator: Vibeke Koushede, PhD University of Southern Denmark
Study Chair: Christian Gluud, MD Copenhagen Trial Unit, Center for Clinical Intervention Research
Study Chair: Morten Grønbæk, MD University of Southern Denmark
More Information

Abidin RR. The Determinants of Parenting Behavior. Journal of Clinical Child Psychology 1992 Dec;21(4):407-12.
Cowan CP, Cowan PA. When partners become parents: The big life change for couples. Mahwah NJ: Lawrence Erlbaum Associates Publishers; 2000.
Deater-Deckard K. Parenting stress and child adjustment: Some old hypotheses and new questions. Clinical Psychology-Science and Practice 1998;5(3):314-32
National Board of Health D. Status on regional and municipal offers in relation to pregnancy and delivery with focus on delivery and early discharge ( In Danish: Status for regionernes og kommunernes tilbud til gravide og fødende med fokus på ambulante fødsler og tidlige udskrivelser). Copenhagen: National Board of Health, Denmark; 2011. Report No.: j.nr. 7-205-03-31/1/chb.
Dunkley J. Health promotion in midwifery practise: a resource for health professionals. Edinburgh: Bailliere Tindall; 2000.
Brot C, Poulsen A. Recommendations in relation to antenatal care 2009 (In Danish: Anbefalinger for svangreomsorgen 2009). Copenhagen: National Board of Health, Denmark; 2009.
Nutbeam D, Kickbusch I. Advancing health literacy: a global challenge for the 21st century. Health Promotion International 2000 Sep;15(3):183-4.
Illeris K, Jarvis P, Kegan R, Engeström Y, Elkjaer B, Mezirow J, et al. Contemporary Theories of Learning: Learning Theorists...in their own words. New York: Routledge; 2009.
Bartholomew L.K, Parcel G.S, Kok G, Gottlieb N.H, Fernández M.E. Planning Health Promotion Programs - An intervention mapping approach. 3 rd ed. San Francisco: Jossey-Bass; 2011.
Whittakar KA, Cowley S. An effective programme is not enough: a review of factors associated with poor attendance and engagement with parenting support programmes. Children and Society 2010.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vibeke Koushede, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01672437     History of Changes
Other Study ID Numbers: Nyfødt -DP -269
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Keywords provided by Vibeke Koushede, University of Southern Denmark:
Birth and parent preparation
Parenting stress
social network and support

Additional relevant MeSH terms:
Behavioral Symptoms