Preconception Screening for Women

Overseen By Shannon I Maloney, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Under 19, Over 49, Not female

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{2 3 10 11 12}

Research Team

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

Group I: Patient-centered Pre-conception Screening Experimental Treatment 1 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 Screening Active Control 1 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: Control Active Control 1 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?"

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception, Interconception, and reproductive health screening tools: A systematic review. Ren, M., Shireman, H., VanGompel, EW., et al.[2023]

Promoting preconception health can significantly improve women's health and pregnancy outcomes by addressing risky behaviors and chronic conditions, as evidenced by data from 40,388 respondents in the Pregnancy Risk Assessment Monitoring System (PRAMS) and 62,875 respondents in the Behavioral Risk Factor Surveillance System (BRFSS).

The findings highlight the need for targeted interventions to reduce unintended pregnancies and risky behaviors, as well as to improve access to healthcare and preventive services for women of reproductive age, particularly among diverse racial and ethnic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core state preconception health indicators - pregnancy risk assessment monitoring system and behavioral risk factor surveillance system, 2009. Robbins, CL., Zapata, LB., Farr, SL., et al.[2022]

A study involving 193 women showed that self-administered questionnaires for preconception health assessment had an excellent agreement with physician-verified answers, indicating they are reliable for identifying risk factors for adverse pregnancy outcomes.

The overall agreement for the Preconceptional Health Assessment form was very high (kappa = 0.88), suggesting that these questionnaires can effectively facilitate preconception care in various healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception care: a screening tool for health assessment and risk detection. de Weerd, S., van der Bij, AK., Cikot, RJ., et al.[2015]

A large study involving 89,946 women revealed that many non-pregnant Dutch women preparing for pregnancy reported a significant number of health risk factors, indicating a need for improved pre-conception care.

Women over 36 years old, of non-Western descent, and those living in urban or deprived areas exhibited higher risk profiles, suggesting that tailored approaches to pre-conception care are necessary for different socio-demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining Pre-Conception Risk Profiles Using a National Online Self-Reported Risk Assessment: A Cross-Sectional Study. Vink-van Os, LC., Birnie, E., van Vliet-Lachotzki, EH., et al.[2018]

The self-administered online questionnaire for preconception risk assessment showed good to high agreement with traditional history taking for most lifestyle and medical history factors, indicating its effectiveness as a screening tool.

However, the questionnaire had poor agreement regarding over-the-counter drug use and unreliable results for partner's family history, highlighting the need for follow-up interviews by healthcare professionals to ensure accurate risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an internet questionnaire for risk assessment in preconception care. Landkroon, AP., de Weerd, S., van Vliet-Lachotzki, E., et al.[2022]

Observational data, particularly from the German Embryotox institute, are crucial for assessing drug safety in pregnancy, as they help estimate relative risks for birth defects and other developmental issues through prospective cohort studies.

Effective drug counseling during pregnancy requires individualized risk assessments and the integration of high-quality data on pregnancy outcomes after drug exposure, as demonstrated with examples like acetaminophen and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug safety in pregnancy-a particular challenge]. Schaefer, C.[2019]

The study introduces a new multistate model for assessing pregnancy risk that considers both conception and gestation outcomes, allowing for earlier intervention by obstetricians before conception occurs.

Using data from the EAGeR trial, the new risk assessment tool effectively distinguishes between different pregnancy outcomes, significantly improving prediction accuracy compared to random chance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multistate competing risks framework for preconception prediction of pregnancy outcomes. Cook, K., Perkins, NJ., Schisterman, E., et al.[2022]

The preconception checklist tool was effective in identifying common health needs among 6,530 women across China, Lebanon, and the Philippines, highlighting the importance of modern contraceptives, immunization, HIV and STI screening, anemia treatment, and weight management counseling.

This pilot study suggests that the checklist can be adapted to different cultural contexts, paving the way for future validation and standardization to improve preconception care policies globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception health assessment in China, Lebanon and the Philippines: applicability to other countries. Reeve, ME., Charafeddine, L., Zhong, N., et al.[2021]

The National Preconception Health and Health Care Initiative identified nine core measures to assess a woman's preconception wellness, which is crucial for improving health outcomes for women and their future children.

These measures include factors like pregnancy intention, access to care, multivitamin use, and avoidance of tobacco and certain medications, aiming to standardize and improve the quality of preconception care across health care systems.

NCBI (Pubmed)

pubmed.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. Frayne, DJ., Verbiest, S., Chelmow, D., et al.[2021]

Preconception health care is crucial for improving women's health and reducing poor birth outcomes by identifying and mitigating risk factors related to family health history, medical conditions, and lifestyle choices.

Resources and screening tools are available to help health care providers efficiently incorporate preconception health education into their practices, making it easier to assist individuals in planning for a healthy pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception Care Resources: Where to Start. Nobles-Botkin, J., Lincoln, A., Cline, J.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Development and validation of preconception care improvement scale (PCIS) in a resource-limited setting. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Preconception health: a public health challenge. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Preconception, Interconception, and reproductive health screening tools: A systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Core state preconception health indicators - pregnancy risk assessment monitoring system and behavioral risk factor surveillance system, 2009. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Preconception care: a screening tool for health assessment and risk detection. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Determining Pre-Conception Risk Profiles Using a National Online Self-Reported Risk Assessment: A Cross-Sectional Study. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of an internet questionnaire for risk assessment in preconception care. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Drug safety in pregnancy-a particular challenge]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A multistate competing risks framework for preconception prediction of pregnancy outcomes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Preconception health assessment in China, Lebanon and the Philippines: applicability to other countries. [2021]

11. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Preconception Care Resources: Where to Start. [2017]