NCT01739101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

November 28, 2012

Last Update Submit

December 12, 2012

Conditions

Delayed ChildbearingPregnancyHealth BehaviorLifestyle

Outcome Measures

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

    2 months after the intervention

Secondary Outcomes (1)

  • Family Planning Intentions

    2 months after the intervention

Other Outcomes (1)

  • Experience of the intervention

    2 months after the intervention

Study Arms (3)

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.

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.

Interventions

Reproductive Life PlanBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Visitor at the Student Health Clinic

You may not qualify if:

  • Not speaking Swedish
  • Male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Student Health Centre

Uppsala, 753 10, Sweden

Location

Related Publications (4)

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

    PMID: 12514353BACKGROUND

  • 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.

    PMID: 19901694BACKGROUND

  • 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.

    PMID: 16617292BACKGROUND

  • 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.

    PMID: 23842564DERIVED

Related Links

MeSH Terms

Conditions

Reproductive BehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jenny Stern

    Uppsala University

    PRINCIPAL INVESTIGATOR

  • Tanja Tydén, PhD

    Uppsala University

    STUDY DIRECTOR

  • Margareta Larsson, PhD

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD-student

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

SE(1)