Pregnancy Clinical Trial
Official title:
Reproductive Life Plan-based Counseling With Men
Verified date | May 2017 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Many women and men in fertile age are at risk for sexual transmitted infections and unwanted pregnancies, and have insufficient knowledge of health promoting lifestyle prior to conception. There is a need to increase awareness among people in fertile age about how sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy outcomes. Previous studies on preconception health and care have mainly focused on women. The aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife could increase men's reproductive knowledge. The second aim was to evaluate men's experiences of the intervention.
Status | Completed |
Enrollment | 229 |
Est. completion date | April 25, 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Visitors at drop-in hours at two clinics testing for sexually transmitted infections Exclusion Criteria: - Non-Swedish speaking - Female gender identity |
Country | Name | City | State |
---|---|---|---|
Sweden | The RFSU clinic | Stockholm | |
Sweden | Flogsta Mansmottagning | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University |
Sweden,
Frey KA, Navarro SM, Kotelchuck M, Lu MC. The clinical content of preconception care: preconception care for men. Am J Obstet Gynecol. 2008 Dec;199(6 Suppl 2):S389-95. doi: 10.1016/j.ajog.2008.10.024. — View Citation
Stern J, Larsson M, Kristiansson P, Tydén 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. — View Citation
Warner JN, Frey KA. The well-man visit: addressing a man's health to optimize pregnancy outcomes. J Am Board Fam Med. 2013 Mar-Apr;26(2):196-202. doi: 10.3122/jabfm.2013.02.120143. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knowledge of reproduction, measured by a total knowledge score | Knowledge of reproduction will be measured by knowledge of the following items: the viability of an ovum the viability of sperm 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 the proportion of infertility-cases that are caused by a male factor success rate of IVF-treatment The outcome will be given as a total score, based on number of correct answers to the items above, and compared to the total score at baseline |
2-3 months after the intervention | |
Primary | Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned | The participants will be asked to mention as many factors as they can remember that can impair male fertility could be modified in the preconception period to increase the chances of conception and having a healthy offspring The number of factors mentioned after the intervention will be compared to the number of factors mentioned at baseline |
2-3 months after the intervention | |
Secondary | Overall experiences of the intervention (Likert-scale) | Experience of the intervention is measured on a Likert-scale by the question of - The participants overall experience of the intervention (very positive - very negative) |
2-3 months after the intervention | |
Secondary | Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale) | Experience of discussing RLP with a midwife is measured on a Likert-scale by the question - How was the experience of talking to a midwife about the reproductive life plan (very positive - very negative) |
2-3 months after the intervention | |
Secondary | Generating new thoughts (Likert-scale) | If the intervention could generate new thoughts on reproduction is measured on a Likert-scale by the question - Has the intervention brought new thoughts about reproduction (In very large extent - in very small extent) |
2-3 months after the intervention | |
Secondary | Generating further knowledge seeking (Likert-scale) | If the intervention could lead to further knowledge seeking is measured on by the question - Did the discussion with the midwife lead to a search for more information about reproduction (A lot more - some more - not at all) |
2-3 months after the intervention | |
Secondary | Implications for future health care seeking (Likert-scale) | Whether the availability of discussing RLP with a midwife would be of future interest is measured on a Likert-scale by the question - The likelihood of approaching a midwife if more questions about reproduction occured (Very likely - Very unlikely) |
2-3 months after the intervention | |
Secondary | Implications for implementing RLP-counseling as a routine (yes/no) | The acceptance of implementing RLP-counselling as a routine is measured by the question - Should midwives or other health care professionals routinely discuss the Reproductive Life Plan with their patients (yes/no) |
2-3 months after the intervention | |
Secondary | Likelihood of future lifestyle change (Likert-scale) | Whether participants would consider making a preconception lifestyle change is measured on a Likert-scale by the question - The likelihood among of making a lifestyle change in the future when planning for a pregnancy (Very likely - Very unlikely) |
2-3 months after the intervention | |
Secondary | Importance of discussing fertility and preconception health with men (Likert-scale) | The perceived significance of RLP-counselling is measured on a Likert-scale by the question - The importance of informing/educating men about fertility and preconception health issues (Very important - Very unimportant) |
2-3 months after the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Completed |
NCT02408315 -
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
|
Phase 3 |