The following guidelines are intended only as a general educational resource for hospitals and clinicians, and are not intended to reflect or establish a standard of care or to replace individual clinician judgment and medical decision making for specific healthcare environments and patient situations. Guideline for Medically Indicated Induction of Labor Approved February, 2011 Please note NNEPQIN has separately published “Guideline Suggestions for Elective Induction of Labor”. INTRODUCTION From 1990 to 2006, the national rates of induction of labor have doubled to approximately 22.5% (1). In 2010, many NNEPQIN member hospitals reported overall rates of induction of labor of 28-32%. The benefits of labor induction must be weighed against the potential maternal and fetal risks associated with this procedure (2). The induction of labor may increase the likelihood of neonatal complications or result in unnecessary cesarean section. These risks may be necessary to assume in complicated pregnancies, in which prolongation of gestation presents further risk to the mother or fetus. Prior to initiating the induction, the patient should be counseled about the indications for induction, the agents and methods to be employed, and the risks of failure, cesarean delivery, or fetal compromise. A physician capable of performing cesarean section should be readily available during the induction of labor (3). UNIT STRUCTURE Each hospital’s department of obstetrics should develop written protocols for the induction of labor. Elements of protocols should include (3): Indications for medical and elective induction Methods of induction of labor used Qualifications of staff authorized to administer agents and monitor patients Methods for assessment of the mother and fetus before and during induction Institutional protocols for the prioritizing of resources and scheduling of patients DEFINITIONS Elective Induction: Induction of labor when there is no clear medical benefit to mother or child for delivery at that point in time compared with continuation of pregnancy. Medically Indicated Induction: Induction of labor when there is clear medical benefit to either mother or baby from ending the pregnancy rather than continuing with it. Cervical Ripening: The process of causing softening of the cervix, ultimately leading to partial cervical dilatation and effacement. This is employed when the cervix is considered unripe, prior to induction of labor, for the purpose of increasing success with induction of labor. Induction of Labor: The purposeful stimulation of uterine contractions for the purpose of accomplishing delivery, prior to the natural onset of labor. Augmentation of labor: The stimulation of ineffective uterine contractions after the onset of spontaneous labor, to manage labor dystocia. Labor: Painful and regular contractions with progressive cervical change. Tachysystole: More than 5 contractions in 10 minutes, averaged over a 30 minute period of time. INDICATIONS Conditions considered consistent with the elective induction of labor are defined in “NNEPQIN Guideline Suggestions for Elective Induction of Labor”. Following is a list of medical conditions commonly accepted as indications for induction of labor. This list of indications is not absolute. Post term pregnancy (41 0/7 weeks) Premature rupture of the membranes Intrauterine fetal growth restriction Gestational hypertension/preeclampsia/eclampsia Chorioamnionitis Fetal demise Fetal indications: oligohydramnios, abnormal FHR or biophysical testing, isoimmunization, anomalies Maternal indications: diabetes mellitus, renal disease, pulmonary disease, chronic hypertension, cardiac disease, thrombophilia, or other serious medical conditions impacted by pregnancy 2 CONTRAINDICATIONS Certain clinical conditions may present a higher risk associated with labor and delivery compared to cesarean delivery, and in such cases induction of labor is considered contraindicated. This list is not absolute. Vasa previa/complete placenta previa/partial placental previa Transverse fetal lie Umbilical cord prolapse Previous classical cesarean delivery Active genital herpes infection Previous myomectomy entering the uterine cavity Other clinical conditions may present a higher than average risk for complications and, while not considered contraindications to labor, may warrant closer monitoring. prior low transverse cesarean delivery multifetal pregnancy nonreactive nonstress test TIMING OF DELIVERY When medical complications of pregnancy are present, it is incumbent upon the practitioner to carefully weigh the risks of continuing the pregnancy against the risks of prematurity and the induction process. In many clinical situations there is little data available to guide decision making regarding the proper timing of delivery. In many cases, additional factors such as comorbidities require consideration. Premature rupture of the membranes at term Women presenting at term with premature rupture of the membranes should undergo labor induction upon presentation, to reduce the risk of chorioamnionitis, postpartum febrile morbidity and neonatal antibiotic treatments (4) (Level A). Oxytocin or prostaglandins are effective and safe (5) (Level A). Preterm Premature Rupture of the Membranes Delivery is indicated at 34 0/7 weeks and beyond (6) (Level A). When PPROM occurs at 24-31 weeks, expectant management should be undertaken if no maternal or fetal complications are present (7) (Level C). Delivery at 32-33 weeks can be considered if amniotic fluid samples demonstrate pulmonary maturity (8) (Level A). Otherwise, expectant management may be beneficial. Hypertensive Disorders of Pregnancy Patients with mild chronic hypertension without complications can be delivered at term (9) (Level A). 3 Patients with mild chronic hypertension with a history of prior adverse outcome (e.g., stillbirth) may be candidates for delivery when pulmonary maturity is demonstrated (10) (Level C). Patients with mild preeclampsia may be delivered at term (11) (Level C). In general, the presence of severe preeclampsia is considered an indication for delivery regardless of gestational age (11) (Level C). Gestational Diabetes Mellitus There is a lack of well designed, randomized studies to indicate the most effective strategy for timing the delivery of patients with gestational diabetes. Most comparative studies demonstrate a high level of induction in control groups, due to confounding factors and a low tolerance for suspected complications in this population. Induction of labor for patients with insulin requiring GDM at 38-39 weeks may reduce the risk of macrosomia and shoulder dystocia without increasing the rate of cesarean delivery (12,13) (Level B) Patients with GDM managed medically (insulin or oral hypoglycemic) may benefit from induction at 39 weeks (14) (Level C). Patients with diet-controlled GDM, for whom macrosomia is not suspected, may be managed expectantly up to 41 0/7 weeks (15) (Level C). Patients with poor glucose control may be delivered prior to 39 weeks if pulmonary maturity is documented by amniocentesis (15) (Level C). Pregestational Diabetes Mellitus Patients with well controlled diabetes may be managed expectantly until 40 0/7 weeks, but expectant management beyond that point is generally not recommended (16) (level C). Patients with poor glucose control, a prior stillbirth, vasculopathy, nephropathy or other complicating factors may require delivery prior to 39 weeks. Amniocentesis for fetal lung maturity should be considered in these cases (16) (Level C). Idiopathic oligohydramnios Timing of delivery in cases of oligohydramnios (AFI ≤ 5 centimeters) with an appropriately grown, nonanomalous fetus, a reassuring fetal heart rate pattern, and no maternal disease is controversial. One randomized trial limited to 54 patients at term comparing induction of labor to expectant management showed no difference in outcome (17) (Level A). In an observational study, corrected perinatal mortality in structurally normal fetuses was significantly improved when induction was performed at the time of diagnosis, compared to expectant management (18) (Level B). Some experts recommend delivery at 37-38 weeks without amniocentesis (19) (Level C). 4 Intrauterine Growth Restriction Timing of delivery is individualized, based upon the gestational age, severity of restriction, presence or absence of fetal anomalies or maternal conditions (eg, diabetes, hypertensive disorders), fetal status determined by antenatal testing, and the serial assessment of growth. Delivery near term (34 weeks and greater) is often based on the development of nonreassuring fetal assessment (low BPP score, absence or reversal of umbilical arterial Doppler velocimetry) or the cessation of growth with serial ultrasound at least 2 weeks apart (20) (Level C). In the very preterm pregnancy (32 weeks or less) outcomes are largely impacted by gestational age, and delaying delivery may be best when there is uncertainty about the need for intervention. (21) (Level C). PATIENT ASSESSMENT A thorough evaluation of the mother and fetus is necessary prior to induction in order to identify potential risks and to estimate the likelihood of success. Factors to assess include: The patient’s pregnancy history and medical history Gestational age of the fetus Estimated fetal weight The fetal presenting part The adequacy of the pelvis The cervical status Gestational age and fetal lung maturity In cases of indicated induction of labor prior to term, the risks of fetal prematurity, primarily fetal respiratory compromise, need to be weighed against the benefits of early delivery. The frequencies of respiratory morbidity are reduced when delivery is at 39 weeks (OR 0.6) as compared to 38 weeks (OR 1.4) or 37 weeks (OR 2.5) (22) (Level B). ACOG has published criteria for confirmation of term gestation (39 weeks or greater) (23). Fetal heart tones have been documented for 30 weeks by Doppler. Thirty-six weeks have elapsed since a serum or urine hCG based pregnancy test was reported to be positive. Ultrasound measurement at less than 20 weeks gestation supports gestational age of 39 weeks or greater. Overall neonatal outcome may be improved with delivery at 39 weeks or greater, compared to delivery from 36-38 weeks in the presence of pulmonary maturity determined by amniocentesis (24) (Level B). 5 Cervical status The status of the cervix is the most important predictor of the ability to reach the active phase of labor and achieve vaginal delivery. The most commonly used method of assessment of the cervical status is by use of the Bishop score. A high Bishop score (variably defined as ≥5 or ≥8) indicates a similar likelihood of vaginal birth whether labor is spontaneous or induced. A low Bishop score (<6) is associated with a higher rate of failed induction of labor, particularly in nulliparous women (25) (Level B). When the cervix is unfavorable, cervical ripening should be considered prior to induction of labor. BISHOP SCORING SYSTEM (26) SCORE 0 1 2 3 Dilation (cm) Closed 1-2 3-4 >/=5 Effacement (%) 0-30 40-50 60-70 >/=80 Station Consistency Position -3 -2 -1,0 >/=+1 Firm Medium Soft - Posterior Mid Anterior - INDUCTION OF LABOR METHODS Breast stimulation may be effective for inducing labor, but this is primarily in patients with a favorable cervix (27) (Level B). Amniotomy, when used alone, can be effective when the cervix is favorable. Long periods without contractions can occur after amniotomy alone (28) (Level C). Amniotomy is more effective when used in combination with oxytocin (29) (Level A). The use of cervical ripening methods is indicated when labor induction is indicated, but the cervix is considered unripe or unfavorable for induction of labor. For recommendations regarding cervical ripening methods, refer to the NNEPQIN publication, “Guideline for Cervical Ripening”. Prostaglandins can be used for labor induction, although studies have not always distinguished between the uses of these agents for cervical ripening vs. induction of labor. Repeated doses of prostaglandins, using guidelines as for cervical ripening, can be given for induction of labor with results similar to that of oxytocin (30) (Level B). Oxytocin is used for labor induction when the cervix is considered ripe or favorable for induction. For recommendations regarding the use of oxytocin, refer to the NNEPQIN publication, “Guideline for the Use of Oxytocin”. PROPOSED PERFORMANCE MEASURE The percentage of cases of medical induction of labor in which the indications noted in the patient record are consistent with previously agreed upon departmental indications, and are not considered consistent with an elective induction of labor. 6 REFERNCES 1. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S, et al. Births: final data for 2006. Natl Vital Stat Rep 2009;57:1–102. 2. Agency for Healthcare Research and Quality. Maternal and neonatal outcomes of elective induction of labor. AHRQ Evidence Report/Technology Assessment No. 176. Rockville (MD): AHRQ; 2009. (Systematic review) 3. Guidelines for Perinatal Care, October 2007, American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. — 6th ed. 4. Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, et al. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med 1996;334:1005–10. 5. Ray DA, Garite TJ. Prostaglandin E2 for induction of labor in patients with premature rupture of membranes at term. Am J Obstet Gynecol 1992;166:836–43. 6. Naef RW 3rd, Allbert JR, Ross EL, Weber BM, Martin RW, Morrison JC. Premature rupture of membranes at 34 to 37 weeks' gestation: aggressive versus conservative management. Am J Obstet Gynecol 1998;178:126–30. 7. ACOG Practice Bulletin #80, April 2007, Premature Rupture of Membranes 8. Mercer BM, Crocker LG, Boe NM, Sibai BM. Induction versus expectant management in premature rupture of the membranes with mature amniotic fluid at 32 to 36 weeks: a randomized trial. Am J Obstet Gynecol 1993;169:775–82. 9. Sibai BM, Mabie WC, Shamsa F, Villar MA, Anderson GD. A comparison of no medication versus methyldopa or labetalol in chronic hypertension during pregnancy. Am J Obstet Gynecol 1990;162:960–966; discussion 966–967. 10. ACOG Practice Bulletin #29, July 2001 (Reaffirmed 2010), Chronic Hypertension in Pregnancy 11. Report of the National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy. Am J Obstet Gynecol 2000;183:S1–S22. 12. Kjos SL, Henry OA, Montoro M, Buchanan TA, Mestman JH. Insulin-requiring diabetes in pregnancy: a randomized trial of active induction of labor and expectant management. Am J Obstet Gynecol 1993;169:611–615. 13. Lurie S, Insler V, Hagay ZJ. Induction of labor at 38 to 39 weeks of gestation reduces the incidence of shoulder dystocia in gestational diabetic patients Class A2. Am J Perinatol 1996;13:293–296. 14. Caughey, Aaron B, Obstetrical management of pregnancies complicated by gestational diabetes mellitus, UpToDate, September 2010. 15. ACOG Practice Bulletin #30, September 2001, Gestational Diabetes. 16. ACOG Practice Bulletin #60, March 2005, Pregestational Diabetes Mellitus 17. Ek S, Andersson A, Johansson A, Kublicas M, Oligohydramnios in uncomplicated pregnancies beyond 40 completed weeks. A prospective randomized pilot study on maternal and neonatal outcomes. Fetal Diagn Ther 2005;20,182. 18. Bastide A, Manning F, Harman C, Lange I, Morrison I, Ultrasound evaluation of amniotic fluid: outcome of pregnancies with severe oligohydramnios. Am J Obstet Gynecol 1986;154:895-900. 19. Beloosesky R, Ross MG. Oligohydramnios, UpToDate, December 1, 2009 20. ACOG Practice Bulletin #12, January 2000, Fetal Growth Restriction 7 21. When do obstetricians recommend delivery for a high-risk preterm growth retarded fetus? The GRIT Study Group. Growth Restriction Intervention Trial. Eur J Obstet Gynecol Reprod Biol 1996:67:121. 22. Morrison JJ, et al. Neonatal respiratory morbidity and mode of delivery at term: influencing of timing of elective cesarean delivery. Br J Obstet Gynaecol 1995;102:101 23. ACOG Practice Bulletin #97, August 2008, Fetal Lung Maturity 24. Bates E, Rouse D, Mann M, et al., Neonatal outcomes after demonstrated lung maturity before 39 weeks of gestation. Obstet Gynecol 2010;116:1288. 25. Vrouenraetsm F, Roumen F, Dehing C, et al. Bishop score and risk of cesarean delivery after induction of labor in nulliparous women. Obstet Gynecol 2005;105:690. 26. Bishop E, Pelvic scoring for elective induction. Obstet Gynecol 1964;24:266. 27. Kavanaugh J, Kelly A, Thomas J, Breast stimulation for cervical ripening and induction of labor (Cochrane Review). Cochrane Database Syst Rev 2001;2:CD003392. 28. Bricker L, Luckas M, Amniotomy alone for induction of labour. Cochrane Database Syst Rev 2000; :CD002862 29. Selo-Ojeme D, Pisal P, Lawal O, et al. A randomized controlled trial of amniotomy and immediate oxytocin infusion versus amniotomy and delayed oxytocin infusion for induction of labor at term. Arch Gynecol Obstet 2009;279:813. 30. Kelly A, Kavanaugh J, Thomas J, Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst rev 2003; :CD003101. APPENDIX Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventative Services Task Force I Evidence obtained from at least one properly designed randomized controlled trial. II–1 Evidence obtained from well–designed controlled trials without randomization. II–2 Evidence obtained from well–designed cohort or case–control analytic studies, preferably from more than one center or research group. II–3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence. III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees. Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories: Level A—Recommendations are based on good and consistent scientific evidence. Level B—Recommendations are based on limited or inconsistent scientific evidence. Level C—Recommendations are based primarily on consensus and expert opinion. 8