NewPreBP: Project Newborn -Preparation for Birth and Parenthood (NewPreBP)
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|ClinicalTrials.gov Identifier: NCT01672437|
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : September 18, 2017
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:
- 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.
- 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||Phase|
|Stress Depression Communication Self-efficacy Coping||Other: Birth and parent preparation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1766 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2015|
Experimental: Birth and parent preparation
The following subjects will be covered in the sessions:
Session 1 (25 weeks gestation):
Session 2 (33 weeks gestation):
Session 3 (35 weeks gestation):
Session 4 (5 weeks post-partum):
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.
- Epidural use [ Time Frame: during labour ]Epidural use during will be measured using data from the hospital obstetric database
- 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.
- 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
- Parenting alliance [ Time Frame: 6 months post-partum, 1 year post-partum ]Parenting alliance will be measured by the Parenting Alliance Measure
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, Denmark, 2650|
|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|