300 Participants Needed

Preconception Screening for Women

SI
Overseen ByShannon I Maloney, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Sixteen years have passed since the Centers for Disease Control recommended routine preconception screening and counseling in primary care settings, yet time constraints and low preconception counseling adherence have prevented widespread uptake. This innovative, self-selected preconception screening tool encourages participants to be active in their own care and eliminates the time burden associated with typical pre-selected screening in clinics. This project will generate important knowledge about the promise of utilizing a participant-selected preconception screening tool to promote preconception health behavior change during routine medical encounters for women of reproductive age.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Preconception Screening Questionnaire, Preconception Health Assessment Tool, Preconception Screening Tool?

Research shows that preconception health interventions can improve women's health and pregnancy outcomes by addressing risk factors like smoking, alcohol use, and inadequate nutrition. Screening tools, like questionnaires, help identify these risks early, allowing for timely interventions to prevent adverse pregnancy outcomes.12345

Is preconception screening safe for women?

The research does not provide specific safety data for preconception screening tools, but these tools are generally used to assess health risks before pregnancy, which suggests they are non-invasive and safe for use.56789

How is the Preconception Screening Questionnaire treatment different from other treatments for preconception health?

The Preconception Screening Questionnaire is unique because it is a quick and easy tool that helps identify high-risk behaviors and environmental factors that could affect a woman's health before pregnancy, unlike other treatments that may focus on addressing health issues after conception. It is designed to be completed in just a few minutes and is available in multiple languages, making it accessible and practical for use in various healthcare settings.23101112

Research Team

SI

Shannon I Maloney, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for women of reproductive age who are interested in preconception care. It's designed to help them become active participants in their health by using a self-selected screening tool during routine medical visits.

Inclusion Criteria

I am biologically female.
I am of child-bearing age.
I will visit the clinic for routine check-ups during the study.

Exclusion Criteria

I am not biologically female.
I am either younger than 19 or older than 49 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to receive either preselected preconception screening, patient-selected preconception risk screening, or no screening.

18 months
1 visit (in-person)

Follow-up

Participants are invited to a follow-up interview to discuss their experiences with the preconception tools and how to better incorporate preconception screening and counseling into primary care settings.

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Preconception Screening Questionnaire
Trial Overview The study tests a new approach where patients use a self-selected questionnaire for preconception screening, followed by counseling. The goal is to see if this method improves the uptake and effectiveness of preconception care services.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Patient-centered Pre-conception ScreeningExperimental Treatment1 Intervention
A short form, 2 question screening form which asks participants which preconception health topics they would like to discuss with their doctor today. Includes an option for "None of these. I would not like to discuss how my health can affect fertility and any future pregnancies"
Group II: Risk-based Pre-conception ScreeningActive Control1 Intervention
A long form questionnaire screening for a range of preconception health risk factors including: age, weight, exercise, diet, nutrition, health conditions, risky behaviors, immunization status, prescription medications, birth control use
Group III: ControlActive Control1 Intervention
Participant is asked a single question: "Your health today can make a difference for the pregnancy you experience tomorrow. Do you agree with the statement above?"

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Findings from Research

The Preconception Care Improvement Scale (PCIS) was developed and validated in a study involving 623 pregnant women in Ethiopia, demonstrating good reliability and validity for assessing preconception care.
The PCIS effectively identifies key areas of preconception care, such as substance-related behaviors and disease screening, and shows a positive association with the practice of preconception and antenatal care, indicating its potential to improve maternal and child health outcomes.
Development and validation of preconception care improvement scale (PCIS) in a resource-limited setting.Teshome, F., Birhanu, Z., Kebede, Y.[2022]
Preconception counseling is crucial for improving women's health and preventing adverse pregnancy outcomes, yet it has been largely overlooked by healthcare providers until recently.
The Oklahoma State Department of Health has created a Women's Health Appraisal Questionnaire to help identify high-risk behaviors in women of childbearing age, which can be completed in just 3-5 minutes, facilitating early intervention and support.
Preconception health: a public health challenge.Feuerborn, VR., Pearson, K.[2015]
This systematic review identified 22 standardized tools for preconception and interconception screening applicable in outpatient clinical practice, based on a comprehensive search of over 15,000 studies.
Among the identified tools, 10 were supported by evidence from randomized clinical trials, highlighting the potential for these tools to improve reproductive health outcomes, although further research is needed to assess their long-term effectiveness.
Preconception, Interconception, and reproductive health screening tools: A systematic review.Ren, M., Shireman, H., VanGompel, EW., et al.[2023]

References

Development and validation of preconception care improvement scale (PCIS) in a resource-limited setting. [2022]
Preconception health: a public health challenge. [2015]
Preconception, Interconception, and reproductive health screening tools: A systematic review. [2023]
Core state preconception health indicators - pregnancy risk assessment monitoring system and behavioral risk factor surveillance system, 2009. [2022]
Preconception care: a screening tool for health assessment and risk detection. [2015]
Determining Pre-Conception Risk Profiles Using a National Online Self-Reported Risk Assessment: A Cross-Sectional Study. [2018]
Validation of an internet questionnaire for risk assessment in preconception care. [2022]
[Drug safety in pregnancy-a particular challenge]. [2019]
A multistate competing risks framework for preconception prediction of pregnancy outcomes. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Preconception health assessment in China, Lebanon and the Philippines: applicability to other countries. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Health Care System Measures to Advance Preconception Wellness: Consensus Recommendations of the Clinical Workgroup of the National Preconception Health and Health Care Initiative. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Preconception Care Resources: Where to Start. [2017]
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