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The Reproductive Life Plan in Midwifery Counseling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jenny Stern, Uppsala University
ClinicalTrials.gov Identifier:
NCT01739101
First received: November 28, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Delayed Childbearing
Pregnancy
Health Behavior
Lifestyle
 Behavioral: Reproductive Life Plan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Reproductive Life Plan in Midwifery Counseling

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Knowledge of reproduction [ Time Frame: 2 months after the intervention ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Family Planning Intentions [ Time Frame: 2 months after the intervention ] [ Designated as safety issue: No ]

    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?


Other Outcome Measures:
  • Experience of the intervention [ Time Frame: 2 months after the intervention ] [ Designated as safety issue: No ]

    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


Enrollment: 299
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
The intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care.
 Behavioral: Reproductive Life Plan
A structured discussion based on the Reproductive Life plan, including information about reproduction and a brochure with the same information.
No Intervention: Control group 1
The control group 1 answered a baseline questionnaire in the waiting room and received standard care.
No Intervention: Control group 2
The control group 2 received standard care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Visitor at the Student Health Clinic

Exclusion Criteria:

  • Not speaking Swedish
  • Male
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739101

Locations
Sweden
The Student Health Centre
Uppsala, Sweden, 753 10
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Jenny Stern Uppsala University
Study Director: Tanja Tydén, PhD Uppsala University
Study Director: Margareta Larsson, PhD Uppsala University
  More Information

Additional Information:
Home page of Department of Public Health and Caring Sciences at Uppsala University  This link exits the ClinicalTrials.gov site
Home page of the Student Health Centre  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jenny Stern, RN, PhD-student, Uppsala University
ClinicalTrials.gov Identifier: NCT01739101     History of Changes
Other Study ID Numbers: UU-RLP-RCT-2012
Study First Received: November 28, 2012
Last Updated: December 12, 2012
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on May 16, 2013