Prenatal care is one of the most common preventive services in the United States—over 98% of the almost 4 million patients who give birth each year receive at least some prenatal care. Until the COVID-19 pandemic, prenatal care delivery had remained largely unchanged since 1930. National guidelines recommend a uniform 12- to 14-visit schedule for all patients to deliver evidence-based services. Catalyzed by changes in prenatal care delivery launched during the COVID-19 pandemic, the American College of Obstetricians and Gynecologists (ACOG), in collaboration with the University of Michigan, convened a panel to redesign prenatal care delivery recommendations. The resulting Plan for Appropriate Tailored Healthcare in pregnancy (PATH) is a paradigm shift in prenatal care delivery, providing a more individualized and flexible approach to prenatal care that matches recommended services to patients’ medical needs. The panel identified for low-risk prenatal care delivery a flexible schedule of visits every 6 weeks until 28 weeks, every 4 weeks until 36 weeks, every 2 weeks until delivery. All in-person prenatal care services can be streamlined to 4 visits: the first prenatal visit, 28 weeks, 36 weeks, and 39 weeks. For other visits, telemedicine would be an option for prenatal care delivery if preferred by the patient. We anticipate that outcome research will be necessary to compare this new prenatal method to the traditional delivery of prenatal care. A core outcome set for evaluating evidence for the best frequency and method of delivery (in-person versus audio/video visits) as well as other innovative models of care, including group prenatal care, pregnancy medical homes or wrap around digital support (e.g. OB Nest model) is necessary. Our objective is to develop a clinically relevant core outcome set to standardize outcome selection, collection and reporting across future randomized or observational studies on the frequency of prenatal visits and method of delivery of prenatal care.
ContributorsMark Turrentine, MD (principle investigator) - Baylor College of Medicine
Chris Zahn, MD - American College of Obstetricians and Gynecologists
Sindhu Srinivas, MD - Society of Maternal Fetal Medicine
Wanda Barfield, MD MPH - Centers for Disease Control and Prevention
Tekoa King, CNM MPH - American College of Nurse-Midwives
Beth Choby, MD - American Academy of Family Physicians
Sue Kendig - National Association of Nurse Practitioners in Women's Health
Joia Crear-Perry, MD - National Birth Equity Collaborative
Alex Peahl, MD MSc (senior investigator) - University of Michigan
Disease Category: Pregnancy & childbirth
Disease Name: Prenatal care
Age Range: 12 - 55
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Systematic review
A steering group including healthcare professionals, researchers and pregnant women will be established to develop a core outcome set (COS). The potential core outcomes will be identified from recent published systematic reviews on the frequency of prenatal visits and outcomes reported. A comprehensive inventory of outcomes will be developed in consultation with the study’s steering group. This inventory will be reviewed using a modified eDelphi approach delivered through sequential online surveys using Delphi survey software. We anticipate a 3-round survey. Outcomes will be ranked on a 1 to 9 Linkert scale ranging from least important to critical importance (1 to 3 an outcome is of limited importance, 4 to 6 important but not critical, and 7 to 9 critical). In round 2, participants will receive their own scores and stakeholder group feedback for each round 1 outcome. Participants will be asked to reflect on their own scores and on the scores of other participants. Participants will be given opportunity to share explanations for their ratings through online message boards, which will be collated and shared with scoring summaries. After the round 2 survey has closed, the percentage of participants scoring each outcome will be calculated and tabulated for the stakeholder group. This will be repeated for a round 3. After the round 3 survey has closed, a consensus definition would be identified when > 70% of participants scored the outcome critical for decision-making (a score of 7 to 9) and < 15% of participants in the stakeholder group scored the outcome of “limited importance for decision making” (a score of 1 to 3). This will be followed then by a consensus meeting of the steering committee where a list of the core outcomes will be finalized to form the core outcome set. The core outcome set would then be submitted for publication using the COS-STAD guidelines.