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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01739101
Other study ID # UU-RLP-RCT-2012
Secondary ID
Status Completed
Phase N/A
First received November 28, 2012
Last updated December 12, 2012
Start date March 2012
Est. completion date August 2012

Study information

Verified date December 2012
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 299
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Visitor at the Student Health Clinic

Exclusion Criteria:

- Not speaking Swedish

- Male

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Reproductive Life Plan
A structured discussion based on the Reproductive Life plan, including information about reproduction and a brochure with the same information.

Locations

Country Name City State
Sweden The Student Health Centre Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Johnson 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. — View Citation

Moos MK. Unintended pregnancies: a call for nursing action. MCN Am J Matern Child Nurs. 2003 Jan-Feb;28(1):24-30; quiz 31. Review. — View Citation

Sanders 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Experience of the intervention Experience of the intervention is measure by
The overall experience of the intervention (very positive - very negative)
If the intervention made them think about reproduction in a different way
If the intervention made them search for more information about reproduction
The likelihood of approaching a midwife if they have more questions about reproduction
If they considered that midwifes or other health care professionals routinely should discuss the Reproductive Life Plan with their patients
2 months after the intervention No
Primary 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
2 months after the intervention No
Secondary 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?
2 months after the intervention No
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