39-week Rule Research Articles

997 The impact of ACOG's 39-week rule on fetal death rates in america: a systematic review

997 The impact of ACOG's 39-week rule on fetal death rates in america: a systematic review

Impact of the "39-week rule" on adverse pregnancy outcomes: a statewide analysis.

The "39-week rule," adopted by the American College of Obstetricians and Gynecologists circa 2009, discouraged routine elective induction of labor in early-term gestations (37 weeks 0 days-38 weeks 6 days) to decrease the risk of adverse neonatal outcomes. However, little research exists regarding any unintended adverse pregnancy outcomes associated with this policy shift. This study aimed to quantify the difference in incidence of adverse pregnancy outcomes before and after the implementation of the 39-week rule. Deidentified data from all births in the state of South Carolina from 2000 to 2008 (before the 39-week rule) and from 2013 to 2017 (after statewide implementation and enforcement of the rule) were obtained from the South Carolina Revenue and Fiscal Affairs Office. Demographic data and International Classification of Diseases 9/10 codes were obtained for each birth. Our primary outcome was the incidence of any of the following adverse pregnancy outcomes: cesarean delivery, hypertensive disorders, chorioamnionitis, postpartum hemorrhage, high-degree lacerations, placental abruption, and intensive care unit admission. Propensity score analysis was used to control for age, body mass index, and race. After stratification by propensity score, the Cochran-Mantel-Haenszel test was used to compare the prerule and postrule groups. A total of 633,985 births were eligible for inclusion-412,632 from 2000 to 2008, and 221,353 from 2013 to 2017. There was a significant increase in the primary outcome in the postrule period (39.94% pre vs 42.76% post; P<.01). The incidence of all hypertensive disorders was significantly increased in the postrule period compared with the prerule period (7.75% pre vs 10.1% post; P<.01). The incidence of chorioamnionitis and cesarean delivery also increased in the postrule period (1.45% pre vs 1.92% post; P<.01; 29.6% pre vs 31.82% post; P<.01; respectively). There was a significant increase in the primary outcome following the implementation of the 39-week rule. Although the policy shift was driven by a desire to decrease adverse neonatal outcomes, aggregate benefit was not observed for pregnancy outcomes.

Impact of restricting early-term deliveries on adverse neonatal outcomes: a statewide analysis

The "39-Week Rule" was adopted by the American College of Obstetricians and Gynecologists in 2009 to eliminate nonmedically indicated (elective) deliveries before 39 weeks in an effort to improve neonatal outcomes. Our primary objective was to quantify the effect of this policy change on adverse neonatal outcomes among a cohort of term births in South Carolina. Deidentified data from all births in the state of South Carolina from 2000 to 2008 (before the 39-week rule) and from 2013 to 2017 (after statewide implementation and enforcement of the rule) were obtained from the South Carolina Revenue and Fiscal Affairs Office. Demographic data and International Statistical Classification of Diseases and Related Health Problems Ninth/Tenth Revision codes were obtained for each birth. Our primary outcome was admission to a neonatal intensive care unit. Our secondary outcomes were respiratory morbidities (including respiratory distress syndrome and transient tachypnea of the newborn), hypoxic-ischemic encephalopathy,seizure, sepsis, birth injuries, hyperbilirubinemia, hypoglycemia, and feeding difficulties. Propensity score analysis was used to control for maternal age, body mass index, race, gestational hypertension, infection, placental abruption, and gestational and pregestational diabetes mellitus. After stratification by propensity score, the Cochran-Mantel-Haenszel test was used to compare groups. A total of 620,121 infants were liveborn at term during the 2 study periods. After implementation of the 39-week rule, there was a significant reduction in early-term deliveries. In adjusted analyses, neonatal intensive care unit admission was significantly more common in the postimplementation period. Respiratory morbidities were also significantly more common postimplementation. In contrast, there were significant reductions in birth injuries and hyperbilirubinemia in the postimplementation period. Implementation of the 39-week rule was associated temporally with an increase in adverse neonatal outcomes. The outcomes intended to be reduced by the 39-week rule, including neonatal intensive care unit admission and respiratory morbidity, seem to have increased in incidence despite adherence to the proposed guidelines.

Review of Unsafe Changes in the Practice of Cesarean Section with Analysis of Flaws in the Interpretation of Statistics and the Evidence

Cesarean section is the commonest major operation. Unfortunately, many recent practice-changes have been rushed based on flawed interpretation limited data that are debated in this review. The discussion includes non-closure of the peritoneum, the 39-week rule for elective cesarean, incorrect implementation of four-category urgency classification, and abdominal entry with excessive blunt force. It took NASA two fatal space-shuttle disasters over 18 years to change its culture of dismissing reasoning and observations in addition to numerical data. Reasoning becomes even more important when there is emerging data, especially in soft sciences like medicine. This review discusses flawed science behind the change to “non-closure of peritoneum” in details (and other changes briefly). This practice change was based on narrow mistaken considerations and solely on statistical significance, studying irrelevant short-term outcomes like increased requirement of analgesia. Several statistical mistakes in interpreting this evidence with wider applications are discussed. This weak/flawed evidence has been subsequently disproven by large randomized controlled trials. Small reduction in operating time should never have been a consideration. The merit of hypothesis favoring peritoneal closure to prevent adhesions is very strong to begin with. More importantly, the meta-analysis of available studies shows that closing peritoneum significantly reduces the formation of adhesions, particularly the severe ones. Extensive adhesion of uterus to the abdominal wall is relatively rare to reach statistical significance in small studies but is clinically highly significant due to operative complications. The rushed mistaken recommendation of non-closure of peritoneum should not have been made. However, reversing these changes is perceived as admitting errors, and there is simply no interest in doing so with detriment of the patients. Guidelines should now change their advice on many important aspects of cesarean, as discussed in this review.

577: Impact of the '39 week Rule' on adverse neonatal outcomes: a statewide analysis

To quantify the rates of adverse neonatal outcomes in term births in pre- and post-statewide implementation of the 39 week rule. De-identified data from all term (> 37 weeks gestational age) births in the state from 2000-2008 (prior to the 39-week rule) and 2013-2017 (after statewide implication and enforcement of the rule) were obtained from the Revenue and Fiscal Affairs Office. Demographic data and ICD9/10 codes were obtained for each birth. Primary outcome was a composite of the incidence of RDS, TTN, HIE, seizure, sepsis, birth trauma (bone fracture or neurologic injury), hyperbilirubinemia, hypoglycemia, feeding difficulties, and NICU admissions. Propensity score analysis was used to control for maternal age, maternal BMI, maternal race, maternal gestational hypertensive disorders, infection, abruption,and diabetes. After stratification by propensity score, the Cochran-Mantel-Haenszel test was used to compare the two groups. 620,121 infants were liveborn at term during the study periods (402,139 pre-, 217,982 post-). There was a significant difference in composite neonatal adverse outcomes between the two study periods. However the direction of the difference varied with propensity score stratification. Stratifications corresponding to lower risk pregnancies experienced an increase in the composite outcome, while stratifications corresponding to higher risk pregnancies experienced a decrease. In adjusted analysis, there were statistically significant reductions in brachial plexus injuries, skeletal injuries, peripheral nervous system injuries, and hyperbilirubinemia between pre and post-implementation periods (p < 0.01 for all comparisons). However, there was a statistically significant increase in respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), hypoglycemia, and NICU admissions between pre-and post-implementation periods (p < 0.01 for all comparisons). At a state level, lower risk pregnancies have experienced an increased risk of composite adverse neonatal outcomes following the statewide implementation of the 39 week rule.

62: Impact of the “39-week rule” on adverse maternal outcomes: a statewide analysis

62: Impact of the “39-week rule” on adverse maternal outcomes: a statewide analysis

Association of Widespread Adoption of the 39-Week Rule With Overall Mortality Due to Stillbirth and Infant Death

To improve neonatal morbidity, efforts have been made to reduce elective deliveries prior to 39 weeks' gestation, also known as the 39-week rule. Prolonging pregnancies also prolongs exposure to the risk of stillbirth. The true association of a 39-week rule with mortality is unknown and studies to date have shown conflicting results. To determine if widespread adoption of a 39-week rule, limiting elective deliveries prior to 39 weeks' gestation, is associated with an increase or decrease in overall mortality when considering both stillbirths and infant deaths. This historical cohort study used birth certificate and infant death certificate data in the United States to compare years before and after the adoption of the 39-week rule. Births between 2008 and 2009 were considered to be in the preadoption period (n = 7 322 234), and those between 2011 and 2012 were considered to be in the postadoption period (n = 6 972 626). Included births were singleton, nonanomalous births between 37 0/7 weeks' and 42 6/7 weeks' gestation. Statistical analysis was performed from July 19, 2016, through June 27, 2019. The exposure of interest was the Joint Commission adoption of the 39-week rule as a quality measure. The primary outcomes of interest were stillbirth and infant death. A total of 7 322 234 births (49.0% girls and 51.0% boys) were included in the preadoption period and 6 972 626 births (49.1% girls and 50.9% boys) were included in the postadoption period. Compared with the preadoption period, there was a decrease in the proportion of deliveries at 37 weeks (-0.06%) and 38 weeks (-2.5%) and an increase in the proportion of deliveries at 39 weeks (6.8%) and 40 weeks (0.2%) in the postadoption period (P < .001). The stillbirth rate increased in the postadoption cohort compared with preadoption (0.09% vs 0.10%; P < .001). The infant death rate decreased in the postadoption period compared with preadoption (0.21% vs 0.20%; P < .001). An overall mortality rate of 0.31% was calculated for the preadoption period and 0.30% for the postadoption period (P = .06). Additional analysis in a counterfactual model suggests that up to 34.2% of the difference in mortality could be associated with the 39-week rule. Stable overall perinatal mortality rates were observed in the 2-year period immediately after adoption of the 39-week rule, despite an increase in stillbirth.

Repeat cesarean delivery in the 39-week rule era: outcomes at a community based hospital

Objective: To compare adverse perinatal outcomes between scheduled and unscheduled repeat cesarean deliveries performed prior to 39 weeks' gestation. Materials and Methods: The authors performed a single-center, retrospective cohort study comparing scheduled, and unscheduled repeat cesarean deliveries. Outcomes compared included (1) adverse operative injuries, (2) excessive blood loss, defined as drop in Hg greater than then 97% (3.6 g), or need for blood transfusion, and (3) adverse neonatal outcome (low 5-minute Apgar, or NICU admission). The presence of any adverse event, and the number of adverse events per 100 deliveries were compared between scheduled and unscheduled cases. Results: A total of 724 repeat cesarean deliveries were reviewed, of which 48.9% (n = 354) were unscheduled. There were significantly more adverse outcomes in the unscheduled cesarean cohort (32 per 100 deliveries), compared to the scheduled cesarean cohort (13 per 100 deliveries) (p Conclusion: Almost half (48.9%) of patients with previous cesarean deliveries deliver for either maternal or fetal indication prior to 39 weeks of gestation, and carry greater risk for adverse perinatal outcome.

Risk of Expectant Management and Optimal Timing of Delivery in Low-Risk Term Pregnancies: A Population-Based Study.

The benefits of the 39-week rule have been questioned and concerns of increased stillbirth after adoption of this rule have been raised. Whether expectant management risks outweigh the benefits of awaiting 39 weeks has not been studied. We analyze the risks of expectant management at term and the optimal timing for delivery. All U.S. nonanomalous singleton term deliveries in 2013 were selected, excluding diabetes/hypertension, and low birth weight. Maternal/neonatal complications and stillbirth/infant death were compared among expectant management versus deliveries at each term gestational age. Logistic regression was used to calculate adjust odds ratios of complications according to delivery plan at each gestational age. From approximately 3 million deliveries, maternal complications during expectant management were lower at early term, and became higher at 39 weeks, relative risk [RR] (95% confidence interval [CI]) = 1.18 (1.16-1.19). Neonatal complications during expectant management were lower during early term, and became higher at ≥39 weeks, RR (95% CI) = 1.09 (1.08-1.09). The risk of perinatal mortality in the expectant management group was lower during early term, and became higher at ≥39 weeks, 18.93 (17.83-20.10) versus 17.37 (16.61-18.16), p = 0.010. Complications during expectant management occurring while awaiting full term do not outweigh the benefits of better outcomes from reaching 39 weeks. However, extending beyond 39 weeks may put these pregnancies at an increased risk.

US Term Stillbirth Rates and the 39-Week Rule: A Cause for Concern?

(Am J Obstet Gynecol. 2016;214(5):621.e1–621.e9) The restriction of the use of “elective” delivery before 39 weeks 0 days of gestation, known as “the 39-week rule” or “the Rule,” was mandated in 2010 in the United States. The Rule was applicable to both labor induction and prelabor cesarean delivery, and was developed as higher rates of adverse childbirth outcomes, including infant morbidity and mortality, subsequent to deliveries that occurred before 39 weeks 0 days of gestation had been reported. However, the prospective risk of term stillbirth was known to increase as a function of increasing gestational age, and hence it was speculated that the Rule might increase the overall rate of term stillbirth. This study aimed to determine whether the term stillbirth rate increased during the 7-year period that the 39-week rule was adopted. The number of live births and the number of stillbirths that occurred within each week of gestational age at and further than 37 weeks were obtained from the state health departments for the years 2007 to 2013. The patterns of the timing of term childbirth and term stillbirth were determined as a function of calendar year and gestational age for each state and for the United States overall. The number needed to treat, which represented the number of women who would need to have an early-term delivery without an accepted indication to prevent one term stillbirth, was estimated based on the change in the proportion of deliveries that occurred before the 39th week of gestation in 2013 compared with 2007, and by the estimated change in the incidence of term stillbirth that occurred in 2013 compared with 2007.

US term stillbirth rates and the 39-week rule: a cause for concern?

More than a decade ago an obstetric directive called "the 39-week rule" sought to limit "elective" delivery, via labor induction orcesarean delivery, before 39 weeks 0 days of gestation. In 2010 the 39-week rule became a formal quality measure in the United States. The progressive adherence to the 39-week rule throughout the United States has caused a well-documented, progressive reduction in the proportion of term deliveries occurring during the early-term period. Because of the known association between increasing gestational age during the term period and increasing cumulative risk of stillbirth, however, there have been published concerns that the 39-week rule-by increasing the gestational age of delivery for a substantial number of pregnancies-might increase the rate of term stillbirth within the United States. Although adherence to the 39-week rule is assumed to be beneficial, its actual impact on the US rate of term stillbirth in the years since 2010 is unknown. To determine whether the adoption of the 39-week rulewas associated with an increased rate of term stillbirth in the United States. Sequential ecological study, based on state data, of US term deliveries that occurred during a 7-year period bounded by 2007 and 2013. The patterns of the timing of both term childbirth and term stillbirth were determined for each state and for the United States as a whole. A total of 46 usable datasets were obtained (45 states and the District of Columbia). During the 7-year period, there was a continuous reduction in all geographic entities in the proportion of term deliveries that occurred before 39 weeks of gestation. The overall rate of term stillbirth, when we compared 2007-2009 with 2011-2013, increased significantly (1.103/1000 vs 1.177/1000, RR 1.067, 95% confidence interval 1.038-1.096). Furthermore, during the 7-year period, the increase in the rate of US term stillbirth appeared to be continuous (estimated slope: 0.0186/1000/year, 95% confidence interval 0.002-0.035). Assuming 3.5 million term US births per year, and given 6 yearly "intervals" with this rate increase, it is possible that more than 335 additional term stillbirths occurred in the United States in 2013 as compared with 2007. In addition, during the 7-year period, there was a progressive shift in the timing of delivery from the 40th week to the 39th week. Absent this confounding factor, the magnitude of association between the adoption of the 39-week rule and the increase in rate of term stillbirth might have been greater. Between 2007 and 2013 in the United States, the adoption of the 39-week rule caused a progressive reduction in the proportion of term births occurring before the 39th week of gestation. During the same interval the United States experienced a significant increase in its rate of term stillbirth. This study raises the possibility that the 39-week rule may be causing unintended harm. Additional studies of the actual impact of the adoption of the 39-week rule on major childbirth outcomes are urgently needed. Pressures to enforce the 39-week rule should be reconsidered pending the findings of such studies.

22: Changes in the patterns and rates of term stillbirth in the USA following the adoption of the 39-week rule: a cause for concern?

22: Changes in the patterns and rates of term stillbirth in the USA following the adoption of the 39-week rule: a cause for concern?

508: Increases in the rates of term stillbirth in the USA following the adoption of the 39-week rule: when are the additional stillbirths occurring?

508: Increases in the rates of term stillbirth in the USA following the adoption of the 39-week rule: when are the additional stillbirths occurring?

The 39-week rule and term stillbirth: beneficence, autonomy, and the ethics of the current restrictions on early-term labor induction in the US

The cumulative risk of term stillbirth, i.e., the death of a fetus in utero on or after 37 weeks 0 days of gestation, increases with increasing gestational age throughout the term period (37 weeks 0 days – 41 weeks 6 days)[1]. Despite this fact, a rule – called the 39-week rule – was established in 2009 that restricts labor induction in the 37 and 38 week of pregnancy (i.e., in the “earlyterm period”) unless an accepted/approved “indication” is present (Table 1). [2] The 39-week rule is now a strict clinical guideline that is enforced by professional organizations, governmental agencies and the medical insurance industry[3-5]. The 39-week rule means that a pregnant woman who has an identifiable risk factor for stillbirth but who does not have an accepted “indication” for labor induction has no choice but to wait until at least 39 weeks 0 days before she can be delivered. Unfortunately, the strict application of the 39-week rule has probably led to hundreds early-term stillborn infants in the US over the past few years[6,7]. The purpose of this presentation was to disclose major problems with the development, application and ethics of the 39-week rule. Firstly, the evidentiary foundation of the 39-week rule is composed almost entirely of observational studies (i.e., Level 2 evidence) that contain a variety of serious flaws including confounding by indication, [8-10] confounding by situation, [10-12] selection bias, [13] misclassification bias, [14] incorrect modelling, [8-10] and the use of data from pre-37 week deliveries [10,15] and/or pre-labor cesarean deliveries.[16,17]. Secondly, these observational studies report magnitudes of association between early-term non-indicated labor induction and adverse birth outcomes (as measured in relative risk [RR], odds ratio [OR]) that are not large enough to be used to claim the identification of an underlying “truth” (i.e., that early-term non-indicated labor inductions per se cause adverse birth outcomes). [18] Thirdly, the evidentiary foundation ignores recent higher-quality research that suggests that early-term non-indicated labor induction might provide significant benefits[19-21]. Fourthly, the 39-week rule was created by a process that chose the relatively arbitrary “cutpoint” of 39 weeks 0 days of gestation [22], failed to consider the potential importance of intermediate levels of prenatal risk [23], ignored the opinions and experience of non-academic providers [24], and excluded input from the general public. Fifthly, the 39-week rule ignores the primary importance of the medical ethical principle of Autonomy [25,26]. Autonomy represents the concept that a patient, given that she has a reasonably good understanding of risk and benefit, has the right to either request or refuse any given reasonable medical therapy. The 39-week rule prevents a woman from requesting and receiving a non-indicated induction Correspondence: jnicholson@hmc.psu.edu Department of Family and Community Medicine, Hershey Medical Center, Pennsylvania State University, Hershey, Pennsylvania, USA Table 1 Accepted Indications for Labor Induction