• Institute for Clinical Systems Improvement (ICSI). Routine prenatal care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2008 Aug. 89 p. [290 references]

This is the current release of the guideline.

This guideline updates a previous version: Routine prenatal care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2007 Aug. 87 p. [260 references]

• Preconception and pregnancy (Counseling; Screening)
• Perinatal complications (Prevention; Risk Assessment)

Counseling
Evaluation
Prevention
Risk Assessment
Screening

Family Practice
Internal Medicine
Nursing
Obstetrics and Gynecology
Preventive Medicine

Advanced Practice Nurses
Allied Health Personnel
Health Care Providers
Health Plans
Hospitals
Nurses
Physician Assistants
Physicians
Public Health Departments

• To increase the percentage of pregnant women who receive timely, comprehensive screens for risk factors
• To increase the percentage of pregnant women who receive timely prenatal counseling and education as outlined in the guideline
• To increase the number of first-trimester patients who have documentation of counseling about appropriate aneuploidy screening
• To increase the percentage of vaginal birth after Cesarean (VBAC)-eligible women who receive documented education describing risks and benefits of VBAC
• To increase the rate of appropriate interventions for identified change in status in women with preterm birth (PTB) risk factors

All women who are pregnant or are considering pregnancy

Screening Maneuvers

1. Risk profiles, including preconception risk assessment, preterm labor risks, workplace/lifestyle hazards assessment, infectious disease risks, genetic risks, risks of vaginal birth after Cesarean
2. Height, weight, blood pressure, history, and physical
3. Screening for rubella/rubeola and varicella status
4. Screening for depression and domestic violence
5. Cervix assessment
6. Laboratory studies
   • Cholesterol
   • Cervical cancer screening
   • ABO/Rh/antibodies
   • Syphilis
   • Urine culture
   • Complete blood count (CBC)
   • Fetal aneuploidy screening
   • Hepatitis B surface antigen
   • Human immunodeficiency virus (HIV)
   • Blood lead screening
   • Gonococci/chlamydia
   • Gestational diabetes mellitus test and postpartum surveillance
7. Fetal heart tones, fetal position, fundal height, and optional obstetric ultrasound

Counseling, Education and Interventions

1. Preterm labor (PTL) education and prevention
2. Complete inventory of medications, herbal supplements, and vitamins
3. Accurate recording of menstrual dates
4. Counseling on risks and benefits of vaginal birth after Cesarean
5. Prenatal and lifestyle education

Immunization and Chemoprophylaxis

1. Vaccinations: varicella, rubella/rubeola [measles/mumps/rubella-MMR], hepatitis B, tetanus-diphtheria [Td] booster and influenza
2. RhoGAM - D immunoglobulin
3. Hepatitis B immunoglobulin
4. Nutritional supplements, including folic acid supplementation
5. Progesterone for women at high-risk for preterm delivery
6. Treatment of HIV-infected mothers with a combination antiretroviral therapy using zidovudine as a backbone
7. Intrapartum antibiotic prophylaxis for group B Streptococcus (GBS) culture – positive and negative women

• Cost-effectiveness of prenatal care
• Sensitivity and specificity of screening maneuvers
• Maternal/fetal health outcomes

Searches of Electronic Databases

A literature search of clinical trials, meta-analysis, and systematic reviews is performed.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Conclusion Grades:

Key conclusions (as determined by the work group) are supported by a conclusion grading worksheet that summarizes the important studies pertaining to the conclusion. Individual studies are classed according to the system presented below and are designated as positive, negative, or neutral to reflect the study quality.

Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power.

Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most.

Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results of different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed.

Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion.

Study Quality Designations:

The quality of the primary research reports and systematic reviews are designated in the following ways on the conclusion grading worksheets:

Positive: indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generalizability, and data collection and analysis.

Negative: indicates that these issues have not been adequately addressed.

Neutral: indicates that the report or review is neither exceptionally strong nor exceptionally weak.

Not Applicable: indicates that the report is not a primary reference or a systematic review and therefore the quality has not been assessed.

Evidence Grading System

1. Primary Reports of New Data Collection:

   Class A:

   • Randomized, controlled trial

   Class B:

   • Cohort study

   Class C:

   • Non-randomized trial with concurrent or historical controls
   • Case-control study
   • Study of sensitivity and specificity of a diagnostic test
   • Population-based descriptive study

   Class D:

   • Cross-sectional study
   • Case series
   • Case report

2. Reports that Synthesize or Reflect upon Collections of Primary Reports:

   Class M:

   • Meta-analysis
   • Systematic review
   • Decision analysis
   • Cost-effectiveness analysis

   Class R:

   • Consensus statement
   • Consensus report
   • Narrative review

   Class X:

   • Medical opinion

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Not stated

Expert Consensus

New Guideline Development Process

A new guideline, order set, and protocol is developed by a 6- to 12-member work group that includes physicians, nurses, pharmacists, other healthcare professionals relevant to the topic, along with an Institute for Clinical Systems Improvement (ICSI) staff facilitator. Ordinarily, one of the physicians will be the leader. Most work group members are recruited from ICSI member organizations, but if there is expertise not represented by ICSI members, 1 or 2 members may be recruited from medical groups or hospitals outside of ICSI.

The work group will meet for seven to eight three-hour meetings to develop the guideline. A literature search and review is performed and the work group members, under the coordination of the ICSI staff facilitator, develop the algorithm and write the annotations and footnotes and literature citations.

Once the final draft copy of the guideline is developed, the guideline goes to the ICSI members for critical review.

Not applicable

The guideline developers reviewed published cost analyses.

Internal Peer Review

Critical Review Process

Every newly developed guideline or a guideline with significant change is sent to Institute for Clinical Systems Improvement (ICSI) members for Critical Review. The purpose of critical review is to provide an opportunity for the clinicians in the member groups to review the science behind the recommendations and focus on the content of the guideline. Critical review also provides an opportunity for clinicians in each group to come to consensus on feedback they wish to give the work group and to consider changes necessary across systems in their organization to implement the guideline.

All member organizations are expected to respond to critical review guidelines. Critical review of guidelines is a criterion for continued membership within the ICSI.

After the critical review period, the guideline work group reconvenes to review the comments and make changes, as appropriate. The work group prepares a written response to all comments.

Approval

Each guideline, order set, and protocol is approved by the appropriate steering committee. There is one steering committee each for Respiratory, Cardiovascular, Women's Health, and Preventive Services. The Committee for Evidence-based Practice approves guidelines, order sets, and protocols not associated with a particular category. The steering committees review and approve each guideline based on the following:

• Member comments have been addressed reasonably.
• There is consensus among all ICSI member organizations on the content of the document.
• To the extent of the knowledge of the reviewer, the scientific recommendations within the document are current.
• Either a critical review has been carried out, or to the extent of the knowledge of the reviewer, the changes proposed are sufficiently familiar and sufficiently agreed upon by the users that a new round of critical review is not needed.

Once the guideline, order set, or protocol has been approved, it is posted on the ICSI Web site and released to members for use. Guidelines, order sets, and protocols are reviewed regularly and revised, if warranted.

Revision Process of Existing Guidelines

ICSI scientific documents are revised every 12 to 36 months as indicated by changes in clinical practice and literature. Every 6 months, ICSI checks with the work group to determine if there have been changes in the literature significant enough to cause the document to be revised earlier than scheduled.

Prior to the work group convening to revise the document, ICSI members are asked to review the document and submit comments. During revision, a literature search of clinical trials, meta-analysis, and systematic reviews is performed and reviewed by the work group. The work group will meet for 1-2 three-hour meetings to review the literature, respond to member organization comments, and revise the document as appropriate.

If there are changes or additions to the document that would be unfamiliar or unacceptable to member organizations, it is sent to members to review prior to going to the appropriate steering committee for approval.

Review and Comment Process

ICSI members are asked to review and submit comments for every guideline, order set, and protocol prior to the work group convening to revise the document.

The purpose of the Review and Comment process is to provide an opportunity for the clinicians in the member groups to review the science behind the recommendations and focus on the content of the order set and protocol. Review and Comment also provides an opportunity for clinicians in each group to come to consensus on feedback they wish to give the work group and to consider changes needed across systems in their organization to implement the guideline.

All member organizations are encouraged to provide feedback on order sets and protocol, however responding to Review and Comment is not a criterion for continued membership within ICSI.

After the Review and Comment period, the work group reconvenes to review the comments and make changes as appropriate. The work group prepares a written response to all comments.

The following algorithms are provided in Appendix G of the original guideline document:

• Aneuploidy Testing Integrated Screening Tool
• Aneuploidy Testing Stepwise Sequential Screening Tool
• Aneuploidy Testing Contingency Screening Tool

The type of supporting evidence is not specifically stated for each recommendation.

Appropriate and cost-effective prenatal care

Not stated

• Refer to Annotation #22 in the original guideline document for information on contraindications to vaginal birth after Cesarean (VBAC).
• Vaccination against influenza is contraindicated for women with a history of hypersensitivity to chicken eggs or to vaccine components such as the preservatives.
• High doses of vitamin A and molybdenum supplements are contraindicated in pregnancy.
• Administration of the varicella vaccine during pregnancy is contraindicated.

• This clinical guideline is designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. A guideline will rarely establish the only approach to a problem.
• This clinical guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstances. Patients are urged to consult a health care professional regarding their own situation and any specific medical questions they may have.

Once a guideline is approved for general implementation, a medical group can choose to concentrate on the implementation of that guideline. An action group is formed when a topic is selected as an initiative. In addition to the action group and measures, each medical group sets specific goals they plan to achieve in improving patient care based on the particular guideline(s). Each medical group shares its experiences and supporting measurement results within the action group. This sharing facilitates a collaborative learning environment. Action group learnings are also documented and shared with interested medical groups within the collaborative.

Currently, action groups may focus on one guideline or a set of guidelines such as hypertension, lipid treatment, and tobacco cessation.

Detailed measurement strategies are presented in the original guideline document to help close the gap between clinical practice and the guideline recommendations. Summaries of the measures are provided in the National Quality Measures Clearinghouse (NQMC).

Key Implementation Recommendations

The following system changes were identified by the guideline work group as key strategies for health care systems to incorporate in support of the implementation of this guideline.

1. Use of simple prenatal forms and checklists can provide an inexpensive and effective means of improving implementation of periodic health maintenance and increase the likelihood that providers will put clinical evidence into practice.
2. Use of electronic medical records for computer-generated reminders can significantly improve provider acceptance and implementation of these recommendations.

Staying Healthy

Effectiveness
Patient-centeredness

• Institute for Clinical Systems Improvement (ICSI). Routine prenatal care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2008 Aug. 89 p. [290 references]

Not applicable: The guideline was not adapted from another source.

1997 Aug (revised 2008 Aug)

Institute for Clinical Systems Improvement - Private Nonprofit Organization

The following Minnesota health plans provide direct financial support: Blue Cross and Blue Shield of Minnesota, HealthPartners, Medica, Metropolitan Health Plan, PreferredOne and UCare Minnesota. In-kind support is provided by the Institute for Clinical Systems Improvement's (ICSI) members.

Ob/Gyn Steering Committee

Committee Members: Dale Akkerman, MD (Work Group Leader) (Park Nicollet Health Services) (OB/GYN); Katie Klingberg, MD (Northpoint Health and Wellness) (Family Medicine); Kari Rabie, MD (Southside Community Health Services) (Family Medicine); Jennifer Schriever, MD (Sanford Health System) (Family Medicine); Carol Stark, MD (Family HealthServices Minnesota) (Family Medicine); Peter Van Eerden, MD (Sanford Health System) (Maternal-Fetal Medicine); Georgeanne Croft, CNM (HealthPartners Medical Group) (Nurse Midwifery); Anna Levine, CNM (Park Nicollet Health Services) (Nurse Midwifery); Joan Kreider, MD (HealthPartners Medical Group) (OB/GYN); John Vickers, MD (HealthPartners Medical Group) (OB/GYN); Corinne Esch, RN, CDS (HealthPartners Medical Group) (OB/GYN Nursing); Nancy Jaeckels (Institute for Clinical Systems Improvement) (Implementation Advisor); Amy Murphy, MHHA (Institute for Clinical Systems Improvement) (Implementation Advisor); Linda Setterlund, MA (Institute for Clinical Systems Improvement) (Facilitator)

This is the current release of the guideline.

This guideline updates a previous version: Routine prenatal care. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2007 Aug. 87 p. [260 references]

This summary was completed by ECRI on February 15, 2000. The information was verified by the guideline developer on March 15, 2000. This summary was updated by ECRI on April 19, 2001, May 7, 2002, February 5, 2003, March 25, 2004, November 12, 2004, and October 13, 2005. This summary was updated by ECRI on March 3, 2006 following the FDA advisory on varicella zoster immune globulin (VZIG). This summary was updated by ECRI on November 30, 2006. This NGC summary was updated by ECRI Institute on December 14, 2007, and again on November 19, 2008.

This NGC summary (abstracted Institute for Clinical Systems Improvement [ICSI] Guideline) is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

The abstracted ICSI Guidelines contained in this Web site may be downloaded by any individual or organization. If the abstracted ICSI Guidelines are downloaded by an individual, the individual may not distribute copies to third parties.

If the abstracted ICSI Guidelines are downloaded by an organization, copies may be distributed to the organization's employees but may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Improvement, Inc.

All other copyright rights in the abstracted ICSI Guidelines are reserved by the Institute for Clinical Systems Improvement, Inc. The Institute for Clinical Systems Improvement, Inc. assumes no liability for any adaptations or revisions or modifications made to the abstracts of the ICSI Guidelines.