Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

For women with low-risk pregnancy status, what is the comparative effectiveness of continuous electronic fetal heart rate monitoring versus alternative monitoring to prevent neonatal morbidity and mortality?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Electronic fetal heart rate monitoring: continuous and intermittent, external and internal Hand-held doppler listening device Fetoscope

No monitoring

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Pregnant women, designated low-risk pregnancy status, in the states of active labor, early labor, threatened labor, and premature rupture of the membranes.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Interested in medicaid populations Differences in outcomes and utility of technologies by racial-ethnic variations

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Reduction in: neonatal mortality, neonatal morbidity primary Cesarean section rate operative delivery (use of forceps) maternal mortality maternal morbidity labor induction and augmentation length of stay Increase in patient, maternal-child bonding and family satisfaction

Describe any health-related risks, side effects, or harms that you are concerned about.

overdiagnosis of pregnancy-related complications, impact on maternal physical and mental health at the point of care and subsequent clinical decisions and coordination of care outcomes due to fetal monitoring

implications for antepartum course of care during labor and mode of delivery.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Developmental delays, attention-deficit hyperactivity disorder, and autism
• Functional limitations and disability
• Pregnancy, including preterm birth

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare
• State Children's Health Insurance Program (SCHIP)

Importance

Describe why this topic is important.

Each year there are approximately 4.3 Million births in the USA. Over half of all hospital admissions in America are for maternity. Approximately half of pregnancies are designated low-risk. Childbirth is a common and important event in a woman’s life. The desire for a healthy baby is a preeminent concern.

In the USA, it is very common for all women in labor to have continuous monitoring, despite an apparent absence of evidence for benefit of this intervention in the non-high risk pregnancy. Understanding the comparative effectiveness of fetal heart monitoring and alternative monitoring methods during the antepartum period is critical to assess benefits or harms to mother and baby, including costs associated with monitoring with respect to clinical birth outcomes.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

The value of continuous electronic fetal heart rate monitoring is controversial. The current state of the evidence is somewhat unclear. Fetal monitoring surveillance may do more harm than good and while the intervention may not harm, the value for continuous fetal monitoring during labor is uncertain and a cause for concern and discomfort for women during the labor process. Monitoring may increase risk of further interventions, maternal morbidity, and length of stay without conferring any benefits to the newborn. A comparative effectiveness review which explores fetal heart monitoring modalities in relation to other alternatives will systematically clarify the current evidence on the benefits and harms of this intervention during the course of labor management in low-risk pregnancies.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Hospitals, nurses, midwives, nurse practitioners, and physicians are uncertain about what to recommend. Their practice is influenced by vendors of monitoring devices and persistent concerns of the risk of malpractice suits if there is a bad outcome. An independant AHRQ comparative effectiveness review which helps inform clinical guidance and policy on use of fetal monitoring devices would be of value.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Per above, it will inform the community of ob-gyn's, nurse midwives, nurse practitioners, family practice physicians practicing ob, policy-makers, educators and patients on the harms and benefits of fetal heart monitoring and pregnancy outcomes.

Describe the timeframe in which an answer to your question is needed.

A CER that addresses an IOM and AHRQ high priority population and condition should ideally be completed within a 12-13 month timeline

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

All women in labor are affected by the decisions regarding fetal monitoring. A CER which explores fetal monitoring by subpopulations (ie women of lower socioeconomic status and with less education and limited access to ob care settings vs. women of high socioeconomic status and perhaps? better access to health systems and prenatal care) would be helpful to understand the role for fetal monitoring if any in select subpopulations and if alternative modalities for monitoring (ie watchful waiting, patterns of fetal movement, etc...) are applicable in select settings and population.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Per above, it will inform the community of ob-gyn's, nurse midwives, nurse practitioners, family practice physicians practicing ob, policy-makers, educators and patients on the harms and benefits of fetal heart monitoring and pregnancy outcomes.

Are you making a suggestion as an individual or on behalf of an organization?

Individual

Please tell us how you heard about the Effective Health Care Program

EHC program medical officer