Evidence-based methods for induction of labor (IOL) are underutilized, increasing risk of prolonged induction, complications, and unnecessary costs. To address heterogeneity in response to quality improvement (QI) efforts, an adaptive implementation strategy can “step up” support to hospitals, moving from less to more intensive support to address inadequate hospital improvement. In a statewide network of hospitals, we developed an adaptive implementation strategy (AIS) with three hospital-level components: (1) BASE, delivered virtually, offers provider training, monthly hospital performance reports, technical assistance, and a participation incentive to hospitals (Intensity: Low); (2) LEAD (unit leaders), offers recurring virtual calls to support hospital QI leaders (Intensity: Moderate); and (3) TEAM (maternity clinician team), offers two in-person site visits with bedside maternity clinicians (Intensity: Very High). This study aims to build an optimized AIS that guides sequential decisions about which hospitals should receive BASE, LEAD, and TEAM to increase adherence to evidence-based IOL management at scale in a statewide quality collaborative. A clustered, sequential, multiple-assignment randomized trial design with at least 48 hospitals recruited from the Obstetrics Initiative, a perinatal collaborative quality initiative separately funded by Blue Cross Blue Shield of Michigan and Blue Care Network. Evidence-based induction of labor (EB-IOL) includes (a) dual-agent cervical ripening and (b) early amniotomy. Hospitals will receive BASE for five months (Stage 1; Month 1–5). At Month 6, all hospitals are randomized to augment with LEAD vs. continue BASE only (Stage 2; Month 6–12). Hospitals not achieving Top Performer status (defined as ≥ 80
Current practice guidelines for postpartum pain management lack specific recommendations for opioid prescribing after vaginal births or vaginal births with associated procedures such as operative vaginal birth (ie, forceps, vacuum-assisted birth) and repair of third- or fourth-degree lacerations. This study used adjusted logistic regression models to assess between-hospital variation in opioid prescribing rates and prescription amounts in oral morphine equivalents (OMEs) for vaginal births with associated procedures. We performed a retrospective cohort study across 67 hospitals of 14,690 opioid-naive, nulliparous patients with term births, of whom 7.2% (n=1,053) had operative vaginal births and 4.9% (n=724) had third- or fourth-degree lacerations. In total, 1.8% of patients (n=269) received an opioid prescription, with a median amount of 60 OMEs (IQR 37.5-75). Prescription rate was higher for third- or fourth-degree laceration (11.6%), and prescription amount was highest for operative birth (75 OMEs, IQR 45-90 OMEs). At a hospital level, the largest range of proportion of patients receiving discharge opioid prescriptions was for third- or fourth-degree lacerations (0-66.7%) and the largest amount was for operative birth (25-135 OMEs). Opioid prescribing after vaginal births with associated procedures is higher than for routine vaginal birth and marked by variation among hospitals, highlighting an opportunity for standardization.
Introduction Adults globally are experiencing increases in diseases attributable to overnutrition, yet child undernutrition persists at high levels. This "double burden of malnutrition" increases the risk of nutrition-related non-communicable diseases in mother and child. Evidence-based interventions promote optimal maternal weight or child growth, but gaps remain in implementing them as integrated, sustainable, and equity-focused solutions. Methods and analysis K'ASLEM is an individually randomized, parallel-group Hybrid Type 1 effectiveness-implementation trial in Indigenous Maya communities in Guatemala with high levels of the double burden of malnutrition. We will enroll 766 pregnant women aged ≥16 years at less than 28 weeks' gestation, allocated 1:1 to intervention or comparator. The intervention integrates (a) food supplementation for pregnant and postpartum mothers and their infants and (b) behavioral counseling to optimize maternal weight and promote healthy nutrition, physical activity, and infant feeding practices. The comparator is enhanced usual care. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age z-score at 12 months. Secondary outcomes are child stunting, child development, maternal overweight or obesity, and maternal hemoglobin. We will collect quantitative and qualitative implementation data, use Implementation Mapping to identify factors shaping implementation, and conduct an economic evaluation of costs and cost-effectiveness. Ethics and dissemination Ethics approval was obtained from the Institutional Review Boards of Mass General Brigham and Maya Health Alliance and the Institute of Nutrition of Central America and Panama Research Ethics Committee. Results will be published in peer-reviewed, open-access journals.
BackgroundPain management after childbirth is widely variable, increasing risk of untreated pain, opioid harms, and inequitable experiences of care. The Creating Optimal Pain Management FOR Tailoring Care (COMFORT) clinical practice guideline (CPG) seeks to promote evidence-based, equitable acute peripartum pain management in the United States. We aimed to identify contextual conditions (i.e., barriers and facilitators) and discrete implementation strategies (i.e., theory-based actions taken to routinize a clinical practice) likely to influence COMFORT CPG uptake and specify corresponding multi-component implementation interventions at the perinatal quality collaborative- and unit-level.MethodsWe conducted a qualitative study involving virtual individual interviews and focus groups. Interviews included individuals undergoing childbirth from 2018-2023, (recruited through two online registries), and actively practicing maternity clinicians and surgeons, (recruited via snowball sampling with the eDelphi panel creating the COMFORT CPG), caring for pregnant people in the United States. Focus groups included physicians, midwives, nurses, and unit-based quality improvement (QI) staff working at Michigan hospitals within the Obstetrics Initiative, a statewide perinatal quality collaborative funded by Blue Cross Blue Shield of Michigan and Blue Care Network. The Consolidated Framework for Implementation Research, Expert Recommendations for Implementing Change taxonomy, and Replicating Effective Programs framework informed data collection and analysis. Qualitative content analysis characterized influential contextual conditions, which were linked to implementation strategies and tools using principles of implementation mapping. We then specified multi-component implementation interventions for use by quality collaboratives and unit-based teams.ResultsFrom May-September 2023, we completed 57 semi-structured individual interviews (31 patients, 26 clinicians) and six focus groups (44 QI champions). Participants identified 10 key conditions influential for COMFORT CPG adoption. Findings enabled identification of five collaborative-level implementation strategies, 27 unit-level implementation strategies, and 12 associated tools to promote COMFORT CPG adoption including the specification of each strategy's hypothesized mechanism of action and each tool's goal and potential uses.ConclusionsThis work identifies contextual conditions and implementation strategies and tools at the perinatal quality collaborative and unit levels to promote COMFORT CPG adoption on maternity units. These findings may foster more rapid CPG implementation and thereby promote more equitable and evidence-based perinatal pain management care.
( Birth . 2024;51(3):541-558. doi:10.1111/birt.12809) Rates of opioid prescriptions and amount of medication prescribed for postpartum women vary significantly worldwide, which presents a concern since opioid use itself may lead to addiction. This study focused on understanding the situations in which opioids were prescribed to patients, with the hope to improve postpartum prescribing practices.
(Abstracted from Birth 2024;51:541–558) Management of postpartum pain—including the use of opioids—varies significantly in practice. In Europe, postpartum opioid prescribing is rare; however, in the United States, at least one opioid is prescribed to an estimated 30% of people after vaginal birth and 75% after cesarean delivery (CD).
BackgroundOur objective is to determine the effect of a new national clinical practice guideline (CPG) for pain management after childbirth, as implemented with less vs. more intensive implementation support, on postpartum opioid prescribing.MethodsA quasi-experimental analysis will measure the impact of post-childbirth pain management guidelines on opioid prescribing in a statewide hospital collaborative, overall and among key patient subgroups at risk for inequitable care and outcomes. We will also use a randomized, non-responder design and mixed-methods approaches to evaluate the effects of Replicating Effective Programs (REP), a theory-driven, scalable implementation intervention, and Enhanced REP (E-REP; i.e., REP augmented with facilitation, which is individualized consultation with site champions to overcome local barriers) on the uptake of the CPG. The study will include hospitals within the Obstetrics Initiative (OBI), a perinatal collaborative quality initiative funded by Blue Cross Blue Shield of Michigan that includes 68 member hospitals serving more than 120,000 postpartum people, over approximately 15 months. Hospitals not initially responding to REP—defined by performance <15th percentile of all OBI hospitals for (a) inpatient order for opioid-sparing postpartum pain management (e.g., scheduled acetaminophen and non-steroidal anti-inflammatory drugs when not contraindicated), or (b) amount of opioid prescribed at discharge—will be allocated via block randomization to continue REP or to E-REP. Using interrupted time series analyses, the primary analysis will evaluate the rate of postpartum opioid-sparing prescribing metrics at the time of discharge (primary outcome) and opioid prescription refills and high-risk prescribing (secondary outcomes) before and after CPG implementation with REP. We will evaluate inequities in outcomes by patient, procedure, prescriber, and hospital factors. Exploratory analyses will examine temporal trends in patient-reported outcomes and the effects of continued REP vs. E-REP among slower-responder sites. We will evaluate implementation outcomes (e.g., acceptability, feasibility, costs, needed REP and E-REP adaptations) using clinician and patient surveys and qualitative methods (ClinicalTrials.gov identifier: NCT06285123).DiscussionFindings will inform refinements to the REP and E-REP interventions and add to the literature on the effectiveness of facilitation to promote uptake of evidence-based clinical practices in maternity care.
The harms of combustible cigarette (CC) use in pregnancy for fetal development are well studied. Less understood are the potential impacts of newer non-combustible cigarette alternatives, including electronic cigarettes (ECs). Our goal was to examine whether EC use during pregnancy predicts increased risk of adverse birth outcomes. This retrospective cohort study used data from the Obstetrics Initiative (OBI), a statewide collaborative of 70 maternity hospitals. OBI’s clinical registry of data on nulliparous, term, singleton, and vertex fetal presentation pregnancies were from medical records. Three groups of pregnancy cigarette users (Controls (n = 26,394), CC (n = 2216), and EC (n = 493)) were compared on birth outcomes, controlling for background differences. Controls were defined as nonsmokers of ECs or CCs. Compared to the controls, the EC group had significantly lower birth weight, while the CC group had reduced birthweight and greater rates of arterial cord pH < 7.1. Compared to EC users, CC users had higher rates of neonates requiring antibiotics and NICU admission. Growing evidence suggests ECs are not safer alternatives to CCs and use during pregnancy should be discouraged. Additional research is needed, as non-significant trends for increased risk of several adverse neonatal outcomes following EC use were found, potentially significant in larger studies with average risk for adverse pregnancy outcomes and when frequency and timing of EC exposure are considered.
To utilize a novel, fully quantitative cervical elastography system (FQ-CES) which numerically quantifies cervical stiffness to examine association with onset of labor and mode of delivery. This is a prospective cohort study of pregnant patients who underwent FQ-CES in the 37th week of pregnancy at a routine prenatal visit. We invented FQ-CES, which modifies a transvaginal ultrasound probe to quantify both pressure applied and tissue deformation, thereby yielding a fully quantified strain-based elastography system that provides a numeric quantification (Young’s modulus) of cervical tissue stiffness. This system is operator independent and can be compared across patients and within patients over time. Singleton pregnancies without indication for delivery at 37 weeks were enrolled and FQ-CES were obtained. Patients remained enrolled regardless of their eventual timing or indications for delivery. The primary outcomes were onset of labor (spontaneous-SOL or induced IOL) and mode of delivery. Young’s modulus was log transformed to achieve normality of distribution (logYM). The Wilcoxon rank sum test was performed to assess the tissue FQ-CES with type of labor and mode of delivery. Of 149 patients included, 56 (37.5%) had IOL and 94 (63.1%) had SOL. 132 (88.5%) had vaginal birth and 17(11.4%) had cesarean birth. Cervical elastography at 37 weeks was not significantly different between groups but was nominally higher (indicating a firmer cervix) in those who underwent induction of labor that ended in cesarean delivery. An operator-independent fully quantitative cervical elastography measurement at 37 weeks could be used to identify individuals at higher risk for cesarean birth and allow time to modify clinical care to optimize opportunity for vaginal delivery. Future intervention studies such as outpatient cervical ripening or modified inpatient ripening protocols based on cervical elastography measurement are warranted.
To assess effectiveness and implementation outcomes after standardizing induction of labor (IOL) practices. We conducted a quality improvement project in a high volume, academic medical center to increase utilization of 3 evidence-based IOL practices: 1) dual agent ripening; 2) vaginal misoprostol instead of buccal; 3) early amniotomy (≤ 4 cm). Singletons with intact membranes and initial cervical dilation ≤2 cm were included. Prior cesarean and stillbirth were excluded. We assessed effectiveness (IOL length, cesarean birth) and implementation outcomes (utilization, adoption by admitting services) pre-implementation (PRE; 11/1/21-1/31/22) vs. post-implementation (POST; 3/1/22-4/30/22). Cox proportional hazards models, stratified by parity, and adjusted for age, BMI, dilation, and epidural, were used to test the association between time period and IOL length. Among 495 patients (PRE, n=293, POST, n=202) there were no differences in baseline characteristics other than epidural use (66.9% vs. 78.2%, p=0.006). IOL length was shorter POST (22.0 vs. 18.3 h, p=0.003) with no difference in cesarean (27.7 vs. 26.7%, p=0.82). Time to delivery was faster POST for nulliparas (HR 1.5, 95% CI 1.2-1.9; Figure) and multiparas (HR 1.5, 95% CI 1.1-2.0). Use of each practice increased POST: dual ripening (31.1 vs. 42.6%, p=0.009), vaginal misoprostol (34.5 vs. 68.3%, p< 0.001), and early amniotomy (19.1 vs. 31.7%, p=0.001). Adoption differed across services: Obstetrics increased use in all practices (32.1 vs. 43.5%, p=0.02; 37.1 vs. 70.8%, p< 0.001; 20.4 vs. 33.9%, p=0.003, respectively); Family Medicine increased use of dual ripening (0.0 vs. 40.0%, p=0.001) and vaginal misoprostol (11.1 vs. 60.0%, p=0.001), but not early amniotomy (11.1 vs. 20.0%, p=0.43); and Midwifery did not increase use of any practice (44.4 vs. 36.8%, p=0.57; 35.6 vs. 52.6%, p=0.20; 17.8 vs. 21.1%, p=0.76, respectively). Standardizing IOL practices leads to shorter IOL without increasing cesarean birth providing the opportunity to improve obstetric outcomes, decrease morbidity, and maximize system efficiency.
INTRODUCTION: Birthing people with opioid use disorder (OUD) and chronic pain (CP) face significant barriers to effective postpartum pain management including medical complexity of analgesic decisions as well as stigma and bias towards individuals with these diagnoses. To date, clinical practice guidelines (CPGs) for patients with OUD and CP have lacked patients’ perspectives. We sought to capture voices of patients and their medical providers to inform effective, equitable pain management CPGs for birthing people with OUD and CP. METHODS: We performed a subgroup analysis of 31 patient and 22 provider interviews conducted to develop CPGs. Institional review board approval was obtained along with participant consent, and data were de-identified. We isolated quotes pertaining to OUD and CP from participants with and providers caring for individuals with these conditions. We then used inductive thematic analysis, allowing insights to emerge from the data. RESULTS: In total, 266 quotes were identified relating to OUD and CP. Five key themes emerged from the data: 1) the need to mitigate health care team bias to improve pain management access and experience; 2) the need for standardized sets of pain management options for all patients; 3) the importance of tailoring pain management plans to individuals’ unique needs; 4) the need to partner with patients in creating pain management plans to promote trust and autonomy; and 5) the importance of interprofessional teams in treating postpartum pain for individuals with OUD and CP. CONCLUSION: Interviews with patients and the people who care for them reveal important considerations for CPGs that improve rather than exacerbate existing disparities for birthing people with OUD and CP. Implementation of CPGs informed by patients’ lived experiences is a crucial step in ensuring equitable options for postpartum pain management in patients who face significant biases and barriers to effective care.
To compare opioid prescribing practices following non-obstetrical procedures in pregnancy among public versus private insurance enrollees. We performed a retrospective cohort study using claims data from Truven Medicaid (public) and Truven Marketscan (private) for all opioid-naive patients aged 18-55 undergoing a procedure in pregnancy from 01/01/2016 to 12/31/2020. We included opioid-naive patients (e.g., no opioid prescription in pregnancy) who underwent 6 common procedures from 270 to 4 days prior to childbirth admission. Outcomes included opioid prescribing characteristics (e.g., receipt of opioid, prescription size in 5 mg tabs of oxycodone). Descriptive statistics and tests of comparison were used to summarize the data. Among those undergoing all procedure types, 10.1% (2,080 of 23,396 patients) had non-obstetrical procedures and were opioid-naive (Public: 790 of 7,324 [10.8%]; Private 1,290 of 16,072 [8.0%]). The most common procedures differed by insurance type (public: laparoscopic (lap.) cholecystectomy [54.1%], lap. appendectomy [21.4%], lap. oophorectomy [17.3%]; private: lap. cholecystectomy [40.1%], lap. oophorectomy [25.8%], lap. appendectomy [25.5%]). The procedure with the highest proportion of opioid prescribing for public enrollees was lap. oophorectomy (84.7%, Median: 20); For private enrollees, this was lap. cholecystectomy (77.0%, Median: 14.5). Of those who received opioid prescriptions, the proportion of patients who received a prescription and prescription size were higher for five of the six procedures for patients with public compared to private insurance. Compared to patients with private insurance those with public insurance more commonly received an opioid prescription following procedures in pregnancy and received larger prescription sizes. Because one in 25 patients who receive an opioid prescription during pregnancy will develop new-persistent opioid use, standardized pain management guidelines for pregnant patients may reduce this observed inequity and reduce the risk of harm from opioid overprescribing.
Social and structural determinants of health include historical, social, political, and economic forces, many of which are rooted in racism and inequality, that shape the relationship between environmental conditions and individual health. Unmet social needs can increase the risk of many conditions treated by obstetrician-gynecologists (ob-gyns), including, but not limited to, preterm birth, unintended pregnancy, infertility, cervical cancer, breast cancer, and maternal mortality. An individual health care professional's biases (whether overt or unconscious) affect delivery of care and may exacerbate and reinforce health disparities through inequitable treatment. Obstetrician-gynecologists and other health care professionals should seek to understand patients' health care decision making not simply as patients' individual-level behavior, but rather as the result of intersecting sociopolitical conditions, structural inequities, and social needs that create and maintain inequalities in health and health care. Recognizing the importance of social and structural determinants of health can help ob-gyns and other health care professionals to better understand patients, effectively communicate about health-related conditions and behavior, and contribute to improved health outcomes, including patients' experience of care and their trust in the health care system.
To compare opioid prescribing practices following obstetric procedures in pregnancy across opioid-naive patients and patients diagnosed with opioid use disorder (OUD). We performed a retrospective cohort study using claims data from Truven Medicaid and Truven Marketscan for patients aged 18-55 who gave birth from 1/1/2016 to 12/31/2020. We included patients who underwent an obstetric procedure in pregnancy from 270 to 4 days prior to childbirth admission. We compared opioid-naive patients (i.e., patients with no opioid prescriptions or diagnoses of OUD in pregnancy) to patients with OUD (i.e., patients with a diagnosis of OUD or who received medication for OUD). Outcomes included receipt of an opioid and prescription size (standardized to 5 mg tabs of oxycodone). Descriptive statistics between patients’ insurance type and opioid exposure were used to summarize the data. Among all patients that underwent an obstetric or non-obstetric procedure, 16,028 of 20,782 patients (77.1%) underwent obstetric procedures in pregnancy (opioid naive: 15,858/20,521; OUD: 170/261). The most common obstetrical procedure was amniocentesis (opioid-naive: 44.4%, OUD: 53.5%), followed by transvaginal cerclage (opioid-naive: 39.3%, OUD: 38.2%), and chorionic villus sampling (CVS; opioid-naive: 15.9%, OUD: 7.6%). Across all procedures, the rate of opioid prescribing was higher for patients with OUD than for opioid-naive patients and higher for patients with public insurance versus private insurance. For example, following amniocentesis, rates of opioid prescribing for patients with OUD with public (32.4%) and commercial (23.5%) insurance were higher than for opioid-naive patients with public (1.0%) or commercial (0.2%) insurance. Patients with OUD and public insurance were more likely to receive opioid prescriptions following obstetric procedures in pregnancy than opioid-naive and commercially insured patients. Future work is needed to define appropriate, tailored prescribing recommendations for these groups that balance opioid stewardship with the need for excellent pain management.
To assess the evidence for key aspects of pain management following vaginal birth, higher-order perineal trauma, and peripartum tubal ligation to inform new clinical practice guidelines. We conducted a systematic review and narrative synthesis of studies addressing post-vaginal birth pain management (opioid medications, non-opioid medications, and nonpharmacologic methods). Studies assessed opioid use, analgesia effects, patient-centered outcomes, and disparities in the general population, patients with opioid use disorder (OUD), chronic pain, and psychiatric conditions. Ovid MEDLINE, Elsevier's Scopus, Elsevier’s Embase, Google Scholar, PubMed, and Web of Science were searched to identify relevant articles. Articles were screened and abstracted by two researchers. Quality was assessed using the RAND/UCLA Appropriateness Methodology approach. Of 2,255 studies screened, 21 were included: 1 high-quality (clinical practice guideline); 7 moderate-quality (RCTs); and 13 low-quality (non-RCTs, observational studies). Two reported that multimodal, non-opioid interventions (e.g. scheduled ibuprofen and acetaminophen) reduced opioid use without increasing pain after vaginal birth. Inpatient strategies and nonpharmacologic studies were limited with mixed results. Three discharge prescribing studies after vaginal birth showed variability and racial/ethnic disparities. Receiving discharge opioid prescriptions was linked to persistent use and opioid-related adverse events. Higher-order perineal trauma and tubal ligation were associated with increased opioid use after discharge. Patients with chronic pain and psychiatric conditions had increased opioid exposure and persistent use. Multimodal oral opioid-sparing strategies provide adequate pain control while limiting opioid use after vaginal birth. Nonpharmacologic methods may provide low-risk enhancement in pain management. There are significant evidence gaps for postpartum pain management in patients with OUD, chronic pain, and psychiatric conditions.
To utilize a novel, fully quantitative cervical elastography system (FQ-CES) to numerically measure cervical stiffness at term to predict mode of delivery. This is a prospective longitudinal cohort study of pregnant patients who underwent FQ-CES starting 37 weeks and weekly thereafter until delivery occurred. We invented FQ-CES, which modifies a transvaginal ultrasound probe to quantify both pressure applied and tissue deformation, thereby yielding a fully quantified strain-based elastography system that provides a numeric quantification (Young’s modulus) of cervical tissue stiffness. This system is operator independent and can be compared across patients and within patients over time. Singleton pregnancies at 37 weeks awaiting spontaneous labor and vaginal delivery were enrolled and had FQ-CES measured weekly until delivery occurred. Patients remained enrolled regardless of their eventual timing or indications for delivery. Young’s modulus was log transformed to achieve normality of distribution (logYM). Cervical tissue logYM from FQ-CES and CL were analyzed over pregnancy using linear mixed effect models. A total of 122 patients were included, 109 vaginal births and 12 cesarean births. Cervical tissue stiffness (logYM) decreased from 37 weeks until delivery at a rate of 13% per week (P=0.005). In patients with eventual vaginal birth the softening rate is 15% per week (P=0.001) whereas those with cesarean birth did not soften. The trend lines for rate of softening significantly differed (P=0.02) by eventual mode of delivery. FQ-CES detects different cervical softening patterns at term associated with eventual mode of delivery, which may provide opportunity to define normal and abnormal cervical remodeling ahead of birth.