CClinicalTrials.gg
CompletedNCT01739101Updated Dec 13, 2012

The Reproductive Life Plan in Midwifery Counseling

An interventional study of Reproductive Life Plan in Delayed Childbearing, Pregnancy and Health Behavior, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-13.

Sponsored by Uppsala University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
299
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Delayed Childbearing
  • Pregnancy
  • Health Behavior
  • Lifestyle
03

In context

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Visitor at the Student Health Clinic

Exclusion criteria

Exclusion Criteria:

  • Not speaking Swedish
  • Male
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
299 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralReproductive Life Plan

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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?

    Time frame: 2 months after the intervention

Other outcomes

  1. 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

    Time frame: 2 months after the intervention

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Study locations

1 site
  • The Student Health Centre
    Uppsala, 753 10, Sweden
08

References and documents

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 12514353 ↗
  • 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. PubMed 19901694 ↗
  • 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. PubMed 16617292 ↗
  • Stern 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01739101
Lead sponsor
Uppsala University
Responsible party
Jenny Stern (RN, PhD-student, Uppsala University) — Principal investigator
First posted
Nov 30, 2012
Start date
Mar 2012
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Dec 13, 2012

Study contacts

Jenny Stern
principal investigator · Uppsala University
Tanja Tydén, PhD
study director · Uppsala University
Margareta Larsson, PhD
study director · Uppsala University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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