Depression Clinical Trial
— NewPreBPOfficial title:
NewPreBP: Project Newborn -Preparation for Birth and Parenthood. A Large Interdisciplinary Randomised Trial on the Effect of Birth and Parent Preparation
Verified date | September 2017 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1766 |
Est. completion date | September 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Vibeke Koushede | Copenhagen Trial Unit, Center for Clinical Intervention Research, Danish Cancer Society |
Denmark,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epidural use | Epidural use during will be measured using data from the hospital obstetric database | during labour | |
Secondary | Perceived stress | 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. | baseline, 37 weeks gestation, 9 weeks post-partum, 6 months post-partum, 1 year post-partum | |
Secondary | Parenting stress | 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 | 9 weeks post-partum, 6 months post-partum, 1 year post-partum | |
Secondary | Parenting alliance | Parenting alliance will be measured by the Parenting Alliance Measure | 6 months post-partum, 1 year post-partum |
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