A Swedish population-based reproductive life plan intervention
| ISRCTN | ISRCTN11081163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11081163 |
| Secondary identifying numbers | RFR-385381 |
- Submission date
- 01/11/2016
- Registration date
- 25/11/2016
- Last edited
- 12/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
From an international perspective, Swedish midwives have a unique role in family planning counseling and testing for sexually transmitted infections. They are responsible for about 90% of all prescription of contraceptives. Traditionally, midwives focus on counseling about contraceptive methods with emphasis on their effectiveness and safety. Other aspects of reproductive health are often not discussed and consequently women lack important information about fertility and reproductive health. The aim of this study is to find out whether structured information about reproductive health given by midwifes improves women’s knowledge about the importance of lifestyle for pregnancy planning.
Who can participate?
Women aged 20-40
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives ordinary care at a midwife visit. The other group receives extended oral and written information (leaflet) at a midwife visit about lifestyle factors that affect fertility and pregnancy outcomes, including the effects of smoking, snuff, obesity, alcohol use and folic acid intake. Participants’ knowledge is assessed by questionnaire before and after 2 months after the visit.
What are the possible benefits and risks of participating?
Participants may benefit from better and more extensive information when planning pregnancies in the future. There are no risks involved in this study.
Where is the study run from?
Uppsala University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
March 2016 to January 2017
Who is funding the study?
1. Region Örebro County (Sweden)
2. Bayer HealthCare (Germany)
Who is the main contact?
Prof. Tanja Tyden
Contact information
Scientific
Dept of Women's and Children's Health
Akademiska sjukhuset
Uppsala
75185
Sweden
Study information
| Study design | Randomized trial in primary care setting |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Reproductive life plan intervention - a Swedish randomized controlled trial |
| Study objectives | This study evaluates the effect of structured information (reproductive life plan [RLP]) about reproductive health in maternal health care (primary care setting), on women's knowledge of reproductive health and pregnancy outcomes both long and short term. |
| Ethics approval(s) | Regional Ethics Board Uppsala, 20/08/2014, ref: 2012/101 |
| Health condition(s) or problem(s) studied | Reproductive health |
| Intervention | All women booking an appointment with the midwife regarding preconception care received general information about the study and filled a baseline questionnaire and consent before the visit. Before meeting the midwife the woman took a sealed envelope (the first one) from a box, and the midwife opened this and got the information to which group the patient was randomized. Then, depending on allocation, the patient had either: 1. A traditional visit about prepregnancy care or 2. An extended visit with oral and written information (leaflet) about lifestyle and factors affecting reproduction, including smoking, snuff, obesity, alcohol use and folic acid intake. After the intervention (or control) the patient receives a questionnaire 2 months after the visit with three reminders. Follow up will be done later on through matching the cohort with the national pregnancy register to evaluate if the intervention actually had an effect on lifestyle entering a pregnancy. |
| Intervention type | Behavioural |
| Primary outcome measure | Knowledge of reproduction, assessed by questionnaire at baseline and 2 months after visit |
| Secondary outcome measures | 1. Knowledge of folic acids effect on reproduction, assessed by questionnaire at baseline and 2 months after visit 2. Knowledge of lifestyle effect on reproduction, assessed by questionnaire at baseline and 2 months after visit |
| Overall study start date | 01/03/2016 |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2000, 1000 in each arm |
| Key inclusion criteria | 1. Females aged 20-40 2. Understand Swedish and able to communicate 3. Give written consent to participate in the study |
| Key exclusion criteria | Below 20 years old or over 40 years old |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Sweden
Study participating centre
70185
Sweden
Sponsor information
Research council
Box 1613
Örebro
70116
Sweden
| Website | https://www.regionorebrolan.se/ |
|---|---|
"ROR" |
https://ror.org/00maqj547 |
Funders
Funder type
Research council
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- BHC
- Location
- Germany
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study will generate at least two-three publications about baseline knowledge before the intervention and the results of the effect of the intervention on knowledge score. Time to be confirmed later date. |
| IPD sharing plan | Basic data from the questionnaires are kept locked and safe by the researcher according to ethics approval. |
Editorial Notes
12/10/2017: internal review.
