NCT03679520

New Programme for Antenatal Preparation for Early Parenthood

Completed NA Last updated 13 November 2019

What this trial tests

NA trial testing New programme in Parents in 71 participants. Completed in 31 October 2019.

Timeline

3 September 2018

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	Region Skane
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	71
Start date	3 September 2018
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	7 locations across Sweden

Drugs / interventions tested

• New programme
• Regular programme

Conditions studied

• Parents — all drugs for Parents →

Sponsor

Region Skane — full company profile →

Who can join

Eligibility, any sex, with Parents. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Becoming a parent is a challenging stage in life, which provokes feelings of both excitement and insecurity; parents strive to develop confidence in their parenting role. Studies show that new parents often feel inadequately prepared for early parenthood which may have a negative impact on adjustment to life as a parent as well as health and wellbeing for the whole family.

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Breastfeeding interventions for preventing postpartum depression.
   Lenells M, Uphoff E, Marshall D, Wilson E, et al · · 2025 · cited 1× · PMID 39963955 · DOI 10.1002/14651858.cd014833.pub2