NewPreBP: Project Newborn -Preparation for Birth and Parenthood

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.

Conditions

• Stress
• Depression
• Communication
• Self-efficacy
• Coping

Interventions

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.

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Danish Cancer Society

  collaborator OTHER

• Vibeke Koushede

  lead OTHER

Principal Investigators

• Pernille Due, MD · University of Southern Denmark

• Vibeke Koushede, PhD · University of Southern Denmark

• Christian Gluud, MD · Copenhagen Trial Unit, Center for Clinical Intervention Research

• Morten Grønbæk, MD · University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2014-09-30

Completion

2015-09-30

Countries

• Denmark

Study Locations