New Programme for Antenatal Preparation for Early Parenthood
NCT ID: NCT03679520
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
71 participants
INTERVENTIONAL
2018-09-03
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The overall aim is to develop, pilot test and evaluate a new programme for antenatal preparation for the early parenthood period. The hypothesis is that expectant first-time parents who receive an intervention with a new programme for antenatal preparation for parenthood will show higher scores for parental self-efficacy in the early parenthood period than those who do not receive the intervention. The specific aims for the pilot study are:
1. To assess the acceptability of the procedures for parents and providers (midwives)
2. To estimate the likely rates of recruitment and retention of participants
3. To estimate the effects on outcome measurements in order to calculate the appropriate sample size in a full scale randomized controlled trial (RCT).
Antenatal clinics will be randomised to either intervention group, and provide a new programme of antenatal parental preparation, or to control group and provide a regular programme of antenatal parental preparation. First-time expectant parents will be invited in early pregnancy by the midwives at the antenatal clinics to participate in the study by partaking in an evaluation of the different ways to provide antenatal parental preparation. Parents who agree to participate will receive postal questionnaires before the antenatal parental preparation start and approximately four weeks after giving birth.
Midwives working in antenatal clinics randomised to the intervention group will receive a one-day-education before providing the intervention antenatal parental preparation. These midwives will also receive questionnaires, after the education and after providing the antenatal parental preparation.
All midwives, in both control group and intervention group, providing antenatal parental preparation will be given a form with questions related to the content in the provided programme to fill in.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
NCT03707834
Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
NCT02169024
Pregnancy Weight Tracking Pilot Project
NCT03652766
Fetal Growth and Pregnancy Complications Among Women With Heart Disease
NCT03657823
Screening for Pregnancy Related Pelvic Girdle Pain
NCT05382845
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Details of recruitment and randomisation of Antenatal clinics; Antenatal clinics (ANCs), which offer the most common model (regular) for antenatal parental preparation, as mapped out in a previous study, will be invited to participate in the pilot study which will compare the regular programme for antenatal parental preparation (control group) with a new programme for antenatal parental preparation (intervention group). Cluster randomisation of ANCs will be used to minimise contamination between the different programmes of antenatal preparation in the two groups. Randomisation will be stratified according to Care Need Index (CNI) which is based on socio-demographic variables of expectant mothers registered with the participating ANCs. A mean value of the CNIs of participating ANCs will be calculated, those below the mean value will form one strata and those above the mean value will form the other strata. Half of the ANCs will be randomised to the intervention group and half to the control group.
Details of preparations to provide the new programme intervention; A full-day education will be provided for midwives at the ANCs randomised to the intervention group which will include group leadership skills to facilitate peer learning among parents, evidence-based websites, framework for co-parenting and details regarding the new programme. The education to the midwives will be followed up with personal phone contact 1-2 months after the education, by the educator, in order to give opportunities for questions and clarifications in order to provide the intervention programme.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
New programme
A new programme of antenatal parental preparation provided by midwives to groups with 8-16 individuals. It will include 5 sessions á 2 hours and start in gestational week 25.
New programme
Time for topics related to the time after birth and in reversed chronological order to give an early and joint focus on parenthood for both parents. Involving new parents to share their experiences of early parenthood with expectant parents. Introducing and using evidence-based websites in the sessions A breastfeeding preparation that gives tools to meet common challenges in the initial phase of breastfeeding. Based on principles for adult learning.
Sessions
1. Introduction, life-change of becoming a parent and co-parenting
2. Early parenthood
3. Breastfeeding, caring for the baby and early parenthood
4. and 5 Labour, birth and postnatal care
Regular programme
A regular programme of antenatal parental preparation provided by midwives to groups of 8-16 individuals and encompassing between 5 and 7 hours of antenatal parental preparation.
Regular programme
Antenatal parental preparation "as usual". As no guidelines exist the number of sessions may vary between 2 and 3 sessions and smaller variations in content may also occur.
Sessions
1. (or 1 and 2) Labour, birth and postnatal care
2. or 3 Breastfeeding, caring for the baby and early parenthood
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
New programme
Time for topics related to the time after birth and in reversed chronological order to give an early and joint focus on parenthood for both parents. Involving new parents to share their experiences of early parenthood with expectant parents. Introducing and using evidence-based websites in the sessions A breastfeeding preparation that gives tools to meet common challenges in the initial phase of breastfeeding. Based on principles for adult learning.
Sessions
1. Introduction, life-change of becoming a parent and co-parenting
2. Early parenthood
3. Breastfeeding, caring for the baby and early parenthood
4. and 5 Labour, birth and postnatal care
Regular programme
Antenatal parental preparation "as usual". As no guidelines exist the number of sessions may vary between 2 and 3 sessions and smaller variations in content may also occur.
Sessions
1. (or 1 and 2) Labour, birth and postnatal care
2. or 3 Breastfeeding, caring for the baby and early parenthood
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Intention to participate in group based antenatal parental preparation
* Understand written and spoken Swedish
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lund University
OTHER
Region Skane
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linda J Kvist, PhD
Role: STUDY_CHAIR
Lund University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barnmorskemottagningen Dalby
Dalby, , Sweden
Barnmorskorna Mitt i Skåne
Höör, , Sweden
Barnmorskemottagningen Kävlinge
Kävlinge, , Sweden
Barnmorskemottagningen Knislinge
Knislinge, , Sweden
Barnmorskemottagningen Capio Singelgatan
Malmo, , Sweden
Barnmorskemottagningen Capio Västra hamnen
Malmo, , Sweden
Barnmorskemottagningen Granen
Malmo, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Barimani M, Vikstrom A, Rosander M, Forslund Frykedal K, Berlin A. Facilitating and inhibiting factors in transition to parenthood - ways in which health professionals can support parents. Scand J Caring Sci. 2017 Sep;31(3):537-546. doi: 10.1111/scs.12367. Epub 2017 Jan 31.
Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.
Reece SM. The parent expectations survey: a measure of perceived self-efficacy. Clin Nurs Res. 1992 Nov;1(4):336-46. doi: 10.1177/105477389200100404.
Persson EK, Fridlund B, Dykes AK. Parents' postnatal sense of security (PPSS): development of the PPSS instrument. Scand J Caring Sci. 2007 Mar;21(1):118-25. doi: 10.1111/j.1471-6712.2007.00442.x.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
MRC (2006). Developing and evaluating complex interventions: new guidance. Medical Research Council. Available [2018-08-28] at https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/
Entsieh AA, Hallstrom IK. First-time parents' prenatal needs for early parenthood preparation-A systematic review and meta-synthesis of qualitative literature. Midwifery. 2016 Aug;39:1-11. doi: 10.1016/j.midw.2016.04.006. Epub 2016 Apr 28.
Palsson P, Persson EK, Ekelin M, Kristensson Hallstrom I, Kvist LJ. First-time fathers experiences of their prenatal preparation in relation to challenges met in the early parenthood period: Implications for early parenthood preparation. Midwifery. 2017 Jul;50:86-92. doi: 10.1016/j.midw.2017.03.021. Epub 2017 Mar 31.
Palsson P, Kvist LJ, Ekelin M, Hallstrom IK, Persson EK. "I Didn't Know What to Ask About": First-Time Mothers' Conceptions of Prenatal Preparation for the Early Parenthood Period. J Perinat Educ. 2018 Jun;27(3):163-174. doi: 10.1891/1058-1243.27.3.163.
Feinberg ME. Coparenting and the transition to parenthood: a framework for prevention. Clin Child Fam Psychol Rev. 2002 Sep;5(3):173-95. doi: 10.1023/a:1019695015110.
Bandura, A. (1997). Self-efficacy: the exercise of control. New York: W. H. Freeman and Company.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017/746
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.