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The Reproductive Life Plan in Midwifery Counseling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01739101
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : December 13, 2012
Sponsor:
Information provided by (Responsible Party):
Jenny Stern, Uppsala University

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date December 13, 2012
Study Start Date  ICMJE March 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
Knowledge of reproduction [ Time Frame: 2 months after the intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
Family Planning Intentions [ Time Frame: 2 months after the intervention ]
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?
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
Family Planning Intentions [ Time Frame: 2 months after the intervention ]
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2012)
Experience of the intervention [ Time Frame: 2 months after 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
Original Other Pre-specified Outcome Measures
 (submitted: November 28, 2012)
Experience of the intervention [ Time Frame: 2 months after the intervention ]
 
Descriptive Information
Brief Title  ICMJE The Reproductive Life Plan in Midwifery Counseling
Official Title  ICMJE The Reproductive Life Plan in Midwifery Counseling
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Delayed Childbearing
  • Pregnancy
  • Health Behavior
  • Lifestyle
Intervention  ICMJE Behavioral: Reproductive Life Plan
A structured discussion based on the Reproductive Life plan, including information about reproduction and a brochure with the same information.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Reproductive Life Plan
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2012)
299
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Visitor at the Student Health Clinic

Exclusion Criteria:

  • Not speaking Swedish
  • Male
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01739101
Other Study ID Numbers  ICMJE UU-RLP-RCT-2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jenny Stern, Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jenny Stern Uppsala University
Study Director: Tanja Tydén, PhD Uppsala University
Study Director: Margareta Larsson, PhD Uppsala University
PRS Account Uppsala University
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP