Delayed ChildbearingNCT01739101
The Reproductive Life Plan in Midwifery Counseling
A study testing Reproductive Life Plan in people with Delayed Childbearing and Pregnancy, run by Uppsala University at 1 site in Sweden.
Trial summary
Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and have unrealistic family planning intentions and insufficient knowledge of health promoting lifestyle prior to conception. Without sufficient support from the health care system this can lead to negative consequences. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Childbearing, Pregnancy, Health Behavior
- What is being tested?
- Reproductive Life Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Visitor at the Student Health Clinic
Who cannot join
- Not speaking Swedish
- Male
Trial locations and contacts
1 site in 1 country.
About this study
Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and have unrealistic family planning intentions and insufficient knowledge of health promoting lifestyle prior to conception. Without sufficient support from the health care system this can lead to negative consequences. The aim of our study was to investigate if the usage of the Reproductive Life Plan in midwifery counselling increases women's knowledge of reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary aims were to evaluate the influence on women's family planning and to further explore how women experienced the Reproductive Life Plan-based counselling.
- Conditions
- Delayed Childbearing, Pregnancy, Health Behavior, Lifestyle
- Being tested
- Reproductive Life Plan
- Medical subject headings
- Reproductive Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive Life PlanBehavioural
A structured discussion based on the Reproductive Life plan, including information about reproduction and a brochure with the same information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care. Receives: Behavioral: Reproductive Life Plan |
| Control group 1 | No intervention | The control group 1 answered a baseline questionnaire in the waiting room and received standard care. |
| Control group 2 | No intervention | The control group 2 received standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of reproduction
Knowledge will be measured by knowledge of the following:
- the fecundity of an ovum
- how likely it is that a 25-year old women gets pregnant if she has unprotected intercourse at the time of ovulation
- at what age there is a marked decline in women's ability to become pregnant
- baby take home rate after IVF-treatment
- factors that can impair female fertility
- healthy lifestyle during pregnancy planning
Measured: 2 months after the intervention
Secondary outcomes (1)
Family Planning Intentions
Family planning intentions will be measured by the following questions:
- Do you want (more) children in your life?
- If yes, how many (more) children do you want?
- If yes, at which age would you like to have your first/next child?
- If yes, at which age you like to have your last child?
Measured: 2 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Delayed ChildbearingStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Stern, Uppsala University
- Investigators
- Jenny Stern, Principal investigator, Uppsala UniversityTanja Tydén, PhD, Study director, Uppsala UniversityMargareta Larsson, PhD, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739101
- Sponsor's protocol ID
- UU-RLP-RCT-2012
- Status last verified
- Dec 2012
- First submitted
- 28 Nov 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moos MK. Unintended pregnancies: a call for nursing action. MCN Am J Matern Child Nurs. 2003 Jan-Feb;28(1):24-30; quiz 31.
PubMed 12514353Sanders LB. Reproductive life plans: initiating the dialogue with women. MCN Am J Matern Child Nurs. 2009 Nov-Dec;34(6):342-7; quiz 348-9. doi: 10.1097/01.NMC.0000363681.97443.c4.
PubMed 19901694Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23.
PubMed 16617292Stern J, Larsson M, Kristiansson P, Tyden T. Introducing reproductive life plan-based information in contraceptive counselling: an RCT. Hum Reprod. 2013 Sep;28(9):2450-61. doi: 10.1093/humrep/det279. Epub 2013 Jul 10.
PubMed 23842564
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reproductive Life Plan in Midwifery Counseling
- ClinicalTrials.gov ID
- NCT01739101
- Acronym / sponsor ID
- UU-RLP-RCT-2012
- Conditions
- Delayed Childbearing, Pregnancy, Health Behavior, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many women and men are at risk for sexual transmitted infections and unwanted pregnancies and have unrealistic family planning intentions and insufficient knowledge of health promoting lifestyle prior to conception. Without sufficient support from the health care system this can lead to negative consequences. The aim of our study was to investigate if the usage of the Reproductive Life Plan in midwifery counselling increases women's knowledge of reproduction and particularly knowledge of folic acid intake prior to pregnancy. Secondary aims were to evaluate the influence on women's family planning and to further explore how women experienced the Reproductive Life Plan-based counselling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Reproductive Life PlanThe intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care. |
| Control group 1 | No intervention | –The control group 1 answered a baseline questionnaire in the waiting room and received standard care. |
| Control group 2 | No intervention | –The control group 2 received standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Visitor at the Student Health Clinic
Key exclusion criteria (2 listed)
- Not speaking Swedish
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reproductive Life PlanA structured discussion based on the Reproductive Life plan, including information about reproduction and a brochure with the same information. | Behavioural | Intervention group |
Primary outcome
Knowledge of reproduction
Time frame: 2 months after the intervention
Knowledge will be measured by knowledge of the following: * the fecundity of an ovum * how likely it is that a 25-year old women gets pregnant if she has unprotected intercourse at the time of ovulation * at what age there is a marked decline in women's ability to become pregnant * baby take home rate after IVF-treatment * factors that can impair female fertility * healthy lifestyle during pregnancy planning
1 secondary outcome
Family Planning Intentions
Time frame: 2 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Background: PubMed 12514353Moos MK. Unintended pregnancies: a call for nursing action. MCN Am J Matern Child Nurs. 2003 Jan-Feb;28(1):24-30; quiz 31.
- Background: PubMed 19901694Sanders LB. Reproductive life plans: initiating the dialogue with women. MCN Am J Matern Child Nurs. 2009 Nov-Dec;34(6):342-7; quiz 348-9. doi: 10.1097/01.NMC.0000363681.97443.c4.
- Background: PubMed 16617292Johnson K, Posner SF, Biermann J, Cordero JF, Atrash HK, Parker CS, Boulet S, Curtis MG; CDC/ATSDR Preconception Care Work Group; Select Panel on Preconception Care. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006 Apr 21;55(RR-6):1-23.
- Derived from this study: PubMed 23842564Stern J, Larsson M, Kristiansson P, Tyden T. Introducing reproductive life plan-based information in contraceptive counselling: an RCT. Hum Reprod. 2013 Sep;28(9):2450-61. doi: 10.1093/humrep/det279. Epub 2013 Jul 10.
- Home page of Department of Public Health and Caring Sciences at Uppsala UniversityLink provided by the sponsor.
Related trials for Delayed Childbearing
Active, not recruiting
Youth Outlook on Life Opportunities Study
Childbearing, Delayed, Marriage Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Stern principal investigator
Uppsala University
Tanja Tydén, PhD study director
Uppsala University
Margareta Larsson, PhD study director
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reproductive Life Plan in people with Delayed Childbearing and Pregnancy, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of reproduction (time frame: 2 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739101, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.