Condition category
Pregnancy and Childbirth
Date applied
01/11/2016
Date assigned
25/11/2016
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Tanja Tyden

ORCID ID

Contact details

Dept of Women's and Children's Health
Akademiska sjukhuset
Uppsala
75185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RFR-385381

Study information

Scientific title

Reproductive life plan intervention - a Swedish randomized controlled trial

Acronym

Study hypothesis

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

Regional Ethics Board Uppsala, 20/08/2014, ref: 2012/101

Study design

Randomized trial in primary care setting

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2016

Overall trial end date

01/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females aged 20-40
2. Understand Swedish and able to communicate
3. Give written consent to participate in the study

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

2000, 1000 in each arm

Participant exclusion criteria

Below 20 years old or over 40 years old

Recruitment start date

01/03/2016

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

Örebro and Uppsala Region
Örebro
70185
Sweden

Sponsor information

Organisation

Region Örebro County

Sponsor details

Box 1613
Örebro
70116
Sweden

Sponsor type

Research council

Website

https://www.regionorebrolan.se/

Funders

Funder type

Research council

Funder name

Region Örebro County

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bayer HealthCare

Alternative name(s)

BHC

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

Results and Publications

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.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes