Preconception Screening for Women
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Nebraska
No Placebo Group
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 patients to be active participants in their own care and eliminates the time burden associated with typical preselected screening in clinics. This project will generate important knowledge about the promise of utilizing a patient-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.
12345Is 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.
56789How 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.
23101112Eligibility 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.
Exclusion Criteria
I am either younger than 19 or older than 49 years old.
I am not biologically female.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Patient-centered Pre-conception ScreeningExperimental Treatment1 Intervention
A short form, 2 question screening form which asks patients 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
Patient 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
Research locations nearbySelect from list below to view details:
Nebraska Medicine - Fontenelle ClinicOmaha, NE
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Who is running the clinical trial?
University of NebraskaLead Sponsor
References
Development and validation of preconception care improvement scale (PCIS) in a resource-limited setting. [2022]Preconception care helps to close the gaps in a continuum of care. It is of paramount importance to reduce maternal and child adverse pregnancy outcomes, increase the utilization of services such as antenatal care, skilled delivery care, and post-natal care, and improve the lives of future generations. Therefore, a validated instrument is required. The purpose of this study was to develop and validate the preconception care improvement scale (PCIS) in a resource-limited setting.
Preconception health: a public health challenge. [2015]Minimal attention has been paid to preconception counseling even though good preconception health may be among the most important segments of a woman's life. Only in recent years have most healthcare providers, including obstetricians, realized that the initiation of health care and guidance after conception may be too late to prevent birth defects, low birthweight and infant mortality. The Oklahoma State Department of Health's Birth Defect Registry has developed a Women's Health Appraisal Questionnaire to assist physicians in identifying high-risk behaviors and other condition in the patient's environment that may be linked to detrimental outcomes to the fetus. The Women's Health Questionnaire can be offered to women of childbearing age in the waiting rooms of health clinics. The questionnaire takes about three to five minutes for the patient to complete. Free English and Spanish versions of the Women's Health Appraisal Questionnaire and other preconception tip booklets are being offered to physicians and health departments in Oklahoma. To order the preconception health questionnaire and booklets, there is an order form included in this journal.
Preconception, Interconception, and reproductive health screening tools: A systematic review. [2023]To identify and describe the standardized interconception and preconception screening tools for reproductive health needs that are applicable in general outpatient clinical practice.
Core state preconception health indicators - pregnancy risk assessment monitoring system and behavioral risk factor surveillance system, 2009. [2022]Promoting preconception health can potentially improve women's health and pregnancy outcomes. Evidence-based interventions exist to reduce many maternal behaviors and chronic conditions that are associated with adverse pregnancy outcomes such as tobacco use, alcohol use, inadequate folic acid intake, obesity, hypertension, and diabetes. The 2006 national recommendations to improve preconception health included monitoring improvements in preconception health by maximizing public health surveillance (CDC. 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 2006;55[No. RR-6]).
Preconception care: a screening tool for health assessment and risk detection. [2015]Identification of risk factors for adverse pregnancy outcome is a main component of preconception care, but requires adequate time and knowledge. This study compares self-administered questionnaires to history taking by a physician to evaluate the reliability of such a screening tool for prepregnancy risk detection.
Determining Pre-Conception Risk Profiles Using a National Online Self-Reported Risk Assessment: A Cross-Sectional Study. [2018]To measure the prevalence of health risk factors in women who are preparing for pregnancy, using an online publicly available questionnaire aimed at identifying personal and pre-conception risks and at providing tailored information.
Validation of an internet questionnaire for risk assessment in preconception care. [2022]Validation of a self-administered Internet questionnaire for preconception risk assessment.
[Drug safety in pregnancy-a particular challenge]. [2019]Drug safety in pregnancy is of utmost importance because prenatal exposure to the unborn child may result in side effects with life-long consequences. Data on their risks in pregnancy are scarce for many drugs. Furthermore, there is often uncertainty how to translate risk data into practice.This article aims to identify tools to improve data ascertainment on exposed pregnancies and their outcome. Using the example of the German Embryotox institute, it is demonstrated how to disseminate drug safety knowledge to healthcare professionals and patients for clinical decision-making.Observational data are the most important basis for drug risk assessment in pregnancy. Such data are collected by Embryotox through the risk consultation process. Prospective cohort studies with comparison cohorts allow to estimate relative risks for birth defects, pregnancy loss, and other developmental anomalies. Retrospectively ascertained adverse drug reactions contribute to identification of distinct pattern of congenital anomalies.Drugs in pregnancy counselling require risk characterization dependent on the individual clinical setting: recommendation of treatment of choice (comparative risk assessment between effective drugs), individual risk estimation after (inadvertent) exposure, and assessment of causal relationship in cases of congenital anomalies. Combining counselling and protocols of pregnancy outcome after drug exposure is optimal to cost-efficiently ascertain data of high quality.Using acetaminophen, valproic acid, AT1-receptor blockers and retinoids as examples, recent discussions on drug risks in pregnancy and their clinical implications are presented.
A multistate competing risks framework for preconception prediction of pregnancy outcomes. [2022]Preconception pregnancy risk profiles-characterizing the likelihood that a pregnancy attempt results in a full-term birth, preterm birth, clinical pregnancy loss, or failure to conceive-can provide critical information during the early stages of a pregnancy attempt, when obstetricians are best positioned to intervene to improve the chances of successful conception and full-term live birth. Yet the task of constructing and validating risk assessment tools for this earlier intervention window is complicated by several statistical features: the final outcome of the pregnancy attempt is multinomial in nature, and it summarizes the results of two intermediate stages, conception and gestation, whose outcomes are subject to competing risks, measured on different time scales, and governed by different biological processes. In light of this complexity, existing pregnancy risk assessment tools largely focus on predicting a single adverse pregnancy outcome, and make these predictions at some later, post-conception time point.
Preconception health assessment in China, Lebanon and the Philippines: applicability to other countries. [2021]To test the utility of a preconception checklist tool in identifying preconception health needs of women in three countries; China, Lebanon and the Philippines. An academic medical center within each country participated in the development and testing of a preconception checklist tool, which was administered over a 6 month period to selected target groups in each country. The checklist provided valuable data on the preconception health of 6,530 women. Aggregated data identified common preconception health needs across all countries, including provision of modern contraceptives and adequate immunization coverage; HIV and STI screening; treatment for anemia; and counseling for maintenance of a healthy weight. A preconception checklist tool was found to be useful in distinct cultural settings. The study was a pilot. Future steps include validation and standardization of the checklist, data from which could be used to help shape preconception care policies and implementation strategies.
Health Care System Measures to Advance Preconception Wellness: Consensus Recommendations of the Clinical Workgroup of the National Preconception Health and Health Care Initiative. [2021]Preconception wellness reflects a woman's overall health before conception as a strategy to affect health outcomes for the woman, the fetus, and the infant. Preconception wellness is challenging to measure because it attempts to capture health status before a pregnancy, which may be affected by many different service points within a health care system. The Clinical Workgroup of the National Preconception Health and Health Care Initiative proposes nine core measures that can be assessed at initiation of prenatal care to index a woman's preconception wellness. A two-stage web-based modified Delphi survey and a face-to-face meeting of key opinion leaders in women's reproductive health resulted in identifying seven criteria used to determine the core measures. The Workgroup reached unanimous agreement on an aggregate of nine preconception wellness measures to serve as a surrogate but feasible assessment of quality preconception care within the larger health community. These include indicators for: 1) pregnancy intention, 2) access to care, 3) preconception multivitamin with folic acid use, 4) tobacco avoidance, 5) absence of uncontrolled depression, 6) healthy weight, 7) absence of sexually transmitted infections, 8) optimal glycemic control in women with pregestational diabetes, and 9) teratogenic medication avoidance. The focus of the proposed measures is to quantify the effect of health care systems on advancing preconception wellness. The Workgroup recommends that health care systems adopt these nine preconception wellness measures as a metric to monitor performance of preconception care practice. Over time, monitoring these baseline measures will establish benchmarks and allow for comparison within and among regions, health care systems, and communities to drive improvements.
Preconception Care Resources: Where to Start. [2017]Preconception health care and reproductive life planning are essential to improving women's health and reducing poor birth outcomes. Preconception health care and education provide opportunities to identify risk factors related to family health history, preexisting medical conditions, body weight, nutrition, physical activity, and immunization status. Modifiable risk factors can be mitigated, thereby improving the health of a woman before she becomes pregnant. Preconception health covers a broad range of topics and may be difficult to incorporate into the busy schedules of health care providers. National and state resources have been developed to help health care providers assist women and men of reproductive age (including adolescents) in developing a reproductive life plan, identifying risk factors for adverse pregnancy outcomes, and providing education and resources to assist in addressing risk factors prior to pregnancy. The current amount of literature available on preconception and interconception health can be overwhelming. This article presents some key screening tools and resources that are available to assist busy health care providers and staff. Some of these resources can be obtained at little or no cost and tailored to individual practices.