NewPreBP: Project Newborn -Preparation for Birth and Parenthood

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Danish Cancer Society
Information provided by (Responsible Party):
Vibeke Koushede, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01672437
First received: August 21, 2012
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention
Stress
Depression
Communication
Self-efficacy
Coping
Other: Birth and parent preparation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Epidural use [ Time Frame: during labour ] [ Designated as safety issue: No ]
    Epidural use during will be measured using data from the hospital obstetric database


Secondary Outcome Measures:
  • Perceived stress [ Time Frame: baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum, 1 year post-partum ] [ Designated as safety issue: No ]
    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.

  • Parenting stress [ Time Frame: 9 weeks post-partum, 6 months post-partum, 1 year post-partum ] [ Designated as safety issue: No ]
    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

  • stress frequency [ Time Frame: baseline, 9 weeks post-partum, 6 months post-partum, 1 year post-partum ] [ Designated as safety issue: No ]
    single item question

  • stress intensity [ Time Frame: baseline, 9 weeks post-partum, 6 months post-partum, 1 year post-partum ] [ Designated as safety issue: No ]
    single item question

  • Parenting alliance [ Time Frame: 9 weeks post-partum, 6 months post-partum, 1 year post-partum ] [ Designated as safety issue: No ]
    Parenting alliance will be measured by the Parenting Alliance Measure


Estimated Enrollment: 2350
Study Start Date: November 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672437

Locations
Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Vibeke Koushede
Copenhagen Trial Unit, Center for Clinical Intervention Research
Danish Cancer Society
Investigators
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

Publications:
Abidin RR. The Determinants of Parenting Behavior. Journal of Clinical Child Psychology 1992 Dec;21(4):407-12.
Nutbeam D, Kickbusch I. Advancing health literacy: a global challenge for the 21st century. Health Promotion International 2000 Sep;15(3):183-4.
Milgrom J, Schembri C, Ericksen J, Ross J, Gemmill AW. Towards parenthood: an antenatal intervention to reduce depression, anxiety and parenting difficulties. J Affect Disord 2011 May;130(3):385-94.

Responsible Party: Vibeke Koushede, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01672437     History of Changes
Other Study ID Numbers: Nyfødt -DP -269
Study First Received: August 21, 2012
Last Updated: May 23, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Southern Denmark:
Birth and parent preparation
Parenting stress
Depression
self-efficacy
social network and support

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014