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APPENDIX C A Summary of Three Prematurity Prevention Programs Descr ibed below in outline form are three innovative programs designed to reduce the occurrence of preterm delivery. I. The March of Dimes Multicenter Prevention of Preterm Delivery . Program* A. Location: ThiS program originated at the University of California, San Francisco (UCSF). It has been expanded to include studies at the University of California, San Diego; Northwestern University, Chicago; the University of Alabama, Birmingham; Vanderbilt University, Nashville; and Ohio State University, Columbus. B. Investigators responsible for uroaram: Robert R. Creasy, M.D.; Richard Depp, M.D.; Stephen Entmen, M.D.; Thomas Key, M.~.; Robert Goldenberg, M.D.; and Jay Tams, M.~. C. Funding source: The March of Dimes Birth Defects Foundation. D. Dates of implementation: 1. Original UCSF program: _ . July I, 1978 to May/June, 1985. 2 . Pilot Phase of multicenter program: November 1, 1982 to April 30 r 1983 (baseline preprogram data collected before any intervention initiated). 3. Implementation of multicenter program began July 1, 1982 4. Tentative concluding date: January 1, 1986. Program description 1. Basic type of program: The original San ~rancisco program was a longitudinal demonstration project to test the effectiveness of an educational program for patients at risk of preterm labor and for providers of obstetric care. This program focused on self-detection of early signs of preterm labor to allow patients to be treated as soon as possible with tocolys~s.t The program also . *Program summary prepared by committee member Calvin J. Hobel in consultation with Robert K. Creasy. tThe use of a medication to inhibit uterine activity, described more fully in Chapter 8. 266

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267 included intensive in-service education for the obstetr ic care providers. The same basic program will be implemented in the five new areas; however, at these sites, higher isk patients will be divided randomly into a study group (basic program) and a control group. 2. Health care providers: The program utilizes both physicians and nurse practitioners to carry out risk assessment, to allocate into study/control groups, to provide primary care, and to supervise the overall program. Entry into the study: All new patients who enroll for prenatal care at the designated study sites will have an opportunity to participate in this program. Informed consent will be obtained. Risk assessment will be performed using modifications by Creasy of the scoring system developed by Papiernik {Chapter 21. H~gh-risk patients will be randomized into either the study group or the control group. High-risk patients in the study group will receive weekly pelvic exams to identify early cervical changes. At 22 to 26 weeks of pregnancy, low- risk patients will be rescreened to determine whether events warrant their transfer to the high-risk group. 4. Patient self-detection education program (for study patients only): The program emphasizes the importance of early preterm labor detection and provides instruction on self-detectzon of the subtle symptoms of preterm labor. Patients are trained in self-detection of painless contractions by palpation and are requested to report immediately if any one of five different symptoms develops. All study patients are reevaluated weekly by specially trained nurses. Interventions: The early evaluation of patients, the self-detection education program, and the weekly exam are considered the main interventions in this program. 6. Staff training/education program: In-service training for all providers is given to ensure a prompt response to patient complaints, liberal and early hospitalization, an aggressive therapeutic approach, and awareness of certain contraindications for therapeutic measures. F. Program effectiveness: Preliminary results indicate that during the first 2 years of the San Francisco study, early recognition of preterm labor was significantly improved. About 93 percent of high-risk patients who went into preterm labor and 79 percent of low-risk patients who went into preterm labor were candidates for tocolytic treatment, compared with less than 20 percent before introduction of the program.* In addition, a significant reduction occurred in *Hereon MA, Katz M, and Creasy RR: Evaluation of a preterm birth prevention program: Preliminary report. Obstet. Gynecol. 59:452-456, 1982.

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D. 268 TABLE C.1 Comparison of Preterm Births at University of California at San Francisco (UCSF) and an Aff lliated Institution (AI ~ 1978/79 1979/80 1980/81 1981/82 1982/83 UCSF 6.75 6.75 2.40 3.5 NAa AI 6.90 6.20 7.00 NA NA aNA means not available. the preterm delivery rate compared to the same institution in earlier years and to an affiliated institution. See Table C.1. II. The Los Angeles Prematurity Prevention Program* A. Location: This program is being implemented in selected health centers in the west health districts of Los Angles. There are five study clinics and three nonstudy clinics (controls). These health centers provide prenatal care for patients who deliver at Harbor-UCLA Medical Center. B. Investigators responsible for program: Calvin J. Hobel, M.D.; Robert Bragonier , M.D., Ph.D. ; Michael Ross, M.D. ; Rose Bemis , Re N. N.P . Funding source: Dates of implementation: 1. Pilot Phase: April 15, 1983 to July 15, 1983. 2. Full Implementation: August 15, 1983 to present; anticipated completion date is June 30, 1986. E. Program description 1. Basic type of program: This is a randomized tr ial to test the effectiveness of five different interventions designed to prevent preterm labor, superimposed on an intensive educational program for both patients and providers. Health care providers: The program uses nurse practitioner teams to carry out risk assessment; allocation of intervention; primary care; and supervision of the program components, including education, social service, nutrition, home visits, and the audit of outcome. Entry into the study: A' 1 new patients less than 31 weeks pregnant receive an or zentation and a welcome pamphlet. If the patient elects to participate, she signs an informed consent form. All patients complete a psychological questionnaire, whether or not they choose to participate. Data for r ask assessment is collected! using California Department of Health. 2. 3. *Program summary prepared by committee member Calvin Hobel.

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269 the Problem Oriented Per~natal Risk Assessment System (POPPAS) perinatal record. A complete history is taken, followed by a physical exam with pelvic assessment. All data are entered into a computer system and the patient designated as high or low risk based on a scoring system der ived for this population of patients.* If low-risk, the patient is assigned randomly to either a standard visit schedule or an abbreviated visit schedule. If the low-risk patient is in one of the study clinics, she also receives the education program--thus, within the low-risk population, this study will evaluate the impact of clinic visits and education in preventing a low-risk pregnancy from becoming high-risk. All low-risk patients are reassessed at 28 weeks. If high-risk, the patient is assigned randomly to one of four intervention groups or a control group. 4. Education program: Education is provided for both the health care providers (clinic and hospital) and the patients within the designated health districts. a. The education program for the provider concentrates on the concept of the prevention program, the importance of program design, methods of risk assessment, justification for the interventions, description of the patients' education program, reasons for hospitalization for early preterm labor, importance of continuity of care, and benefits of a successful program. b. The education program for patients is based on three special preterm labor classes that cover the following: a general overview of the prevention program, the detection of signs and symptoms of preterm labor and several other problems that may develop, and information about going to the hospital If preterm labor is suspected and what to expect. Information is also provided on how best to use the telephone for assistance. 5. Interventions; All h~gh-risk patients who agree to participate in this study are assigned randomly to one of the following groups: a. Bed rest: Patients are asked to rest for 1 hour, three times daily (morning, afternoon, and evening). A bed rest log is completed by the patient, which includes an assessment of the presence or absence of uterine contractions. b. Social service: Patients are assigned to a social worker who meets with her at every visit to assess *Ross M, Hobel CJ, Bragonier By, and Bear M: Prematurity: A simplified r isk scor ing system. Obstet. Gynecol. In press.

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270 social problems. provided . Progestational agent: Patients receive oral Provera (medroxyprogesterone acetate) as permitted under a special protocol approved by the FDA. d. Placebo: A number of patients equal to the number in group C are given placebo. Control group: These patients receive no additional intervention other than the education program. F. Program effectiveness: The effectiveness of this program will be determined in four ways. The outcome variable is the incidence of prematur ity: 1. Incidence of prematur ity in control versus study clinics. 2 . Incidence of prematur ity in each of the intervention groups compared to the control group (randomized) and also control clinics (without education). Shifts in preter~birth bir~chweight categories between study and control groups. 4. Comparison of the incidence of prematurity during the study period with the incidence of prematurity in Me same population for a 5-year per iod before the study. Four stress management classes ar e III. The French Prematurity Prevention Program* Locations: Since 1971, the French have stated that reducing the incidence of prematur ity is an important national goal and have developed various plans to meet this goal. One of these strategies has involved the development of a prematurity prevention program, common to three locations: Haguenau (in Eastern France), Clamart (a suburb of Paris}, and Martinique (a Caribbean island under French rule). B. Investigator responsible for the three programs: Emile Papiernik, Professor of Obstetrics and Gynecology, University of Par is-Sud, Hospital Antoine Beclere, France. Ce Funding source: French Government Social Services. D. Dates of implementation: Haguenau, 1971; Clamart, 1972; Martinique, 1978--all to the present. E. Program descr iption: 1. Basic type of program: The French program is a national longitudinal one begun in 1971. It includes certain clinical components, described below, and ~ s supported by complete work leave beginning at 34 weeks, monetary payments for early prenatal care, and free obstetric care. }Iealth care providers: In France, the program of prevention is generally understood by most obstetric care providers--obstetr icians, general practitioners, and midwives--par ticular ly s ince the mid 1970 s, when the *Program sublunary prepared by Emile Papiernik.

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271 concepts outlined here became widely discussed in the French obstetric community. On the island of Martinique, the program was implemented more recently by midwives and is not so much the standard of care. Entry into the program: Patients who seek prenatal care are assessed for risk factors by history and pelvic exam. The risk assessment system used is based on the system described by Papiernik in 1969 (Chapter 2~. Some practitioners use a risk assessment "score card, n while others no longer formally score patients because the notion and content of risk assessment have become a standard part of patient care. The most important parts of the Papiernik risk assessment system are the assessment of lifestyle and physical work, the patients' recognition of uterine contractions, and pelvic examinations to uncover those signs strongly indicative of the risk of preterm labor. 4. Education: The program includes education of: physicians, midwives, and associated personnel concerning --the correct use of risk assessment --the var ions techniques of intervention --the importance of individualizing and personalizing the intervention. b. the public (both men and women) concerning --the availability and importance of early and regular prenatal care --activities that could endanger the pregnancy (long road trips, moving, strenuous activities, and hard physical work). the patients to --increase their awareness of the availability of special individualized preventive care for all women and of care specific to women at high risk --increase their ability to detect uterine contractions early --elicit their cooperation in working with the obstetrical team, and to recognize and report which physical activities trigger contractions. Interventions: Various specific interventions have been used in the French program, but the efficacy of only one has been studied carefully (cervical cerclage). The following interventions are used, with those employed most frequently listed first: a. Reduction of physical exertion accomplished by: a physician's prescription to stop work, which must be honored by employers under law and which must be accompanied by full salary or an equivalent public subsidy; a change to less strenuous ~ ~ in working hours; and/or a general work; a reduction emphasis on rest.

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272 b. Household help through eliciting the support of husband, friends, and family, and/or free domestic help when needed through the local social service system. System of weekly follow-up care at home by midwives for the 5 to 10 percent of patients found to be at high risk for preterm labor. d. Oral progestins--Chlarmadinone acetate was used frequently; however, its use in Clamart has been discontinued. The frequency of its use in France generally is unknown at present. Cervical cerclage--the use of cerclage for classical indications and beyond was common; however, a recent randomized trial in Hag uenau and Clamart indicated that its extended use did not reduce the incidence of prematurity. In fact, it was shown to increase ache preterm rate in soree high-risk patients. Its use is currently restricted to classical indications. F. Program effectiveness: A November 1983 press release from the French government reported an overall drop in preterm births in France from 8.2 percent in 1973 to 5.3 percent in 1982. In the tables that follow, declining rates of preterm births are presented for a Smart teaching hospital, the region of Haguenau, for France generally, and for the Mar tinique program. In the absence of a careful statistical approach to implementing the preterm prevention strategies outlined here, it is not possible to determine the cause of the declines noted.

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273 TABLE C.2 Live Births and Percent Preterm Among Women Followed in the Prenatal Clinic of Chart Teaching Hospital, France, 1973-1983 1973-75 1976-78 1980-83 Births 5009 5594 8212 Percent preterm 6.46 3.37 3.76 Nail;. Preterm births are live births of less than 37 weeks gestation. TABLE C.3 Preterm Births.per 100 Live Births by Week of Gestation in Haguenau, France, 1971-1982 Week of Gestation 1971-74 1975-78 1979-82 <32 1.8 1.3 0.8 33-34 1.2 1.0 0.8 35-36 3.1 2.4 2.5 <37 6.l 4.5 4.2 Now;: - Preterm births are live births of less than 37 weeks gestation. TABLE C.4 Preterm Births per 100 Live Births by Week of Gestation, France, National Representative Studies Week of Gestation 1972 1976 1981 <34 2.4 1.7 1.2 34-36 5.8 5.1 4.4 <37 ~ ;-8.2 6.8 5.6 NOTE;: Preterm births are live births of less. that 37 weeks gestation.

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274 TABLE C.5 Live Births and Percent Preterm Among Women Followed in the Martinique Prenatal Care System 1980 1981 1982 Births 2250 2326 2526 Percent preterm 6.0 5.0 4.4 Per inatal mortality ratea 16 13 12 NOTE: Preterm births are live births of less than 37 weeks gestation aFor infants weighing 500 grams or more e e