Nicolina Smith, Rebecca F Hamm, Jessica Peterson, Alexandra DeRusso Forrest, Nicole A Smith, Jourdan E Triebwasser
{"title":"Society for Maternal-Fetal Medicine Special Statement: Checklists for persons with sickle cell disease in pregnancy.","authors":"Nicolina Smith, Rebecca F Hamm, Jessica Peterson, Alexandra DeRusso Forrest, Nicole A Smith, Jourdan E Triebwasser","doi":"10.1002/pmf2.70365","DOIUrl":"10.1002/pmf2.70365","url":null,"abstract":"<p><p>This article presents checklists designed to guide clinicians in the comprehensive management of pregnant individuals with sickle cell disease, including prepregnancy, antepartum, delivery, and postpartum care, as well as the specific management of vaso-occlusive crises. The checklists aim to standardize care, enhance documentation and communication, and improve maternal and neonatal outcomes. Implementation strategies are discussed, emphasizing the need for integration of checklists into clinical workflows and continuous evaluation of quality indicators to address disparities and optimize patient care.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 5","pages":"e70365"},"PeriodicalIF":0.0,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149043337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Iona M A Palmer, Naima K Chowdhury, Martha Gulati, Helen E Collins, Clara G Sears
{"title":"The cost of chronic strain: Sleep disruption, allostatic load, and the impact on adverse pregnancy outcomes.","authors":"Iona M A Palmer, Naima K Chowdhury, Martha Gulati, Helen E Collins, Clara G Sears","doi":"10.1002/pmf2.70389","DOIUrl":"10.1002/pmf2.70389","url":null,"abstract":"","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 5","pages":"e70389"},"PeriodicalIF":0.0,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149043296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kristan Scott, Rachel F Ledyard, M Emma Bernstein, Abigail Obeng-Marnu, Taneisha R Sinclair, Anne M Mullin, Celeste Durnwald, Timothy D Nelin, Heather H Burris
{"title":"Postpartum visit attendance after spontaneous and medically indicated preterm birth.","authors":"Kristan Scott, Rachel F Ledyard, M Emma Bernstein, Abigail Obeng-Marnu, Taneisha R Sinclair, Anne M Mullin, Celeste Durnwald, Timothy D Nelin, Heather H Burris","doi":"10.1002/pmf2.70381","DOIUrl":"10.1002/pmf2.70381","url":null,"abstract":"<p><strong>Introduction: </strong>Individuals with preterm birth (PTB) are less likely to attend postpartum visits compared to those with term birth but are more likely to have conditions such as hypertensive disorders. PTB can be classified as spontaneous PTB (sPTB) (premature rupture of membranes or preterm labor) and medically indicated PTB (mPTB) (clinician-initiated due to maternal or fetal conditions). We compared postpartum visit attendance after sPTB and mPTB to term birth. We hypothesized that sPTB and mPTB would be associated with increased risk of not attending postpartum visits compared to term, but risk would be higher after sPTB as mPTB is more often preceded by chronic conditions requiring more healthcare engagement.</p><p><strong>Methods: </strong>We performed a retrospective cohort study of births from 2008 to 2019 in <i>GeoBirth</i>, a curated dataset of singleton births in two hospitals in Philadelphia, PA. Two blinded reviewers manually classified each PTB as sPTB or mPTB. We performed bivariate analyses and mixed-effects, multivariable, modified Poisson regression models to calculate risk ratios (RRs) of no postpartum visit after sPTB and mPTB compared to term birth. Models were adjusted for age, parity, hospital, insurance, education, race and ethnicity, cesarean birth, body mass index, diabetes, and hypertension. A linear combination test compared RRs between PTB subtypes.</p><p><strong>Results: </strong>Of the 69,110 included births, 3464 (5.0%) were sPTB and 2755 (4.0%) were mPTB. There were 693 (1.0%) excluded as unclassifiable PTBs. Overall, 37.2% of births had no postpartum visit within 12 weeks, with higher proportions after sPTB (46.5%) and mPTB (42.8%) than term birth (36.4%) (<i>p</i> < 0.001). Compared to term birth, the unadjusted risk of no postpartum care was higher after sPTB (RR, 1.28; 95% confidence interval [CI], 1.23-1.33) than mPTB (RR, 1.18; 95% CI, 1.12-1.23) (<i>p</i> value comparing RRs = 0.004). In a model including all covariates, risk was similarly elevated for both sPTB (aRR, 1.14; 95% CI, 1.11-1.19) and mPTB (aRR, 1.15; 95% CI, 1.10-1.21) (<i>p</i> value comparing RRs = 0.78).</p><p><strong>Conclusion: </strong>Individuals with both sPTB and mPTB are at higher risk of not attending postpartum visits compared to term births. Innovative, collaborative, multidisciplinary efforts are essential to meet the needs of this vulnerable population to ensure postpartum healthcare.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 5","pages":"e70381"},"PeriodicalIF":0.0,"publicationDate":"2026-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149043330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Skylar N Smith, Chloe A Zera, Emma M Anghel, Michelle C Lara, Giselle Chiprez Ramirez, Carrie G Wade, Ann C Celi
{"title":"Educational tools that address pregnancy-related complications in the postpartum period: A scoping review.","authors":"Skylar N Smith, Chloe A Zera, Emma M Anghel, Michelle C Lara, Giselle Chiprez Ramirez, Carrie G Wade, Ann C Celi","doi":"10.1002/pmf2.70327","DOIUrl":"10.1002/pmf2.70327","url":null,"abstract":"<p><p>Previous research provides evidence that the postpartum period is a crucial time for individuals who have just given birth to understand and engage in their health to mitigate current and future risks. The present study is a scoping review of research on educational tools that address pregnancy-related complications for postpartum patients. We aimed to determine the extent to which these tools exist and how they have been studied among postpartum people. PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase were searched from inception to June 2025 to identify publications on patient-facing educational tools for the postpartum period that focus on pregnancy-related complications. Educational tools were evaluated for application to the Capability, Opportunity, and Motivation (COM-B) framework for health behavior change. Of 3216 records, 32 studies met the inclusion criteria, and 11 patient educational tools were accessible for analysis. Two reviewers independently screened and assessed the titles, abstracts, and full texts of identified articles for inclusion. These tools were delivered through a variety of media, including mobile applications and traditional written pamphlets. Topics of the tools included postpartum mental health, hypertensive disorders of pregnancy, gestational diabetes, breastfeeding after a complicated pregnancy, and warning signs for postpartum morbidity and mortality. Enhancers to postpartum care were addressed more often in the educational tools than barriers to postpartum care. The educational tools most often covered the following facilitators of behavior change identified by the COM-B framework: psychological capability, social opportunity, and reflective motivation. This scoping review highlights the limited availability of educational tools for postpartum care and recovery that address pregnancy-related complications. Findings of this scoping review suggest that educational tools that address pregnancy-related complications for postpartum patients were limited in topics covered, language availability, and diversity of postpartum populations tested. Further research is needed to expand the network of accessible postpartum educational tools and to assess the efficacy and acceptability of these educational tools in historically marginalized populations. Structuring these tools within a framework for behavior change such as COM-B may be a useful method for better understanding and improving postpartum care engagement and access to educational resources.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 5","pages":"e70327"},"PeriodicalIF":0.0,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13602980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149043332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Streamlining intrapartum glycemic control: Subcutaneous insulin for intrapartum diabetes management.","authors":"Leah M Savitsky, Chantelle Barr, Ronit Katz, Nadine Martinez, Juliet Henderson, Tara Saleh, Leilani White, LaVone Simmons","doi":"10.1002/pmf2.70371","DOIUrl":"https://doi.org/10.1002/pmf2.70371","url":null,"abstract":"<p><strong>Objective: </strong>Optimal strategies for intrapartum glycemic control among patients with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) remain uncertain. In 2024, our labor and delivery unit implemented a subcutaneous (SC) insulin protocol to replace routine intravenous (IV) insulin initiation when glucose exceeded a treatment threshold. We hypothesized that this change would not worsen neonatal outcomes and would improve nursing (RN) satisfaction.</p><p><strong>Methods: </strong>We conducted a retrospective cohort quality improvement study of patients with GDM or T2DM who delivered at ≥36 weeks between March 2021 and December 2025. July 2024, when the protocol was introduced, was excluded as a washout period. The intervention included both a shift to SC insulin-first management and standardization of intrapartum glycemic treatment to a target of ≤ 120 mg/dL. The primary outcome was a composite of neonatal hypoglycemia or neonatal intensive care unit (NICU) admission for hypoglycemia within 24 h of life. Secondary outcomes included IV insulin duration and RN satisfaction. Outcomes were compared before and after implementation. Poisson regression with an interrupted time series framework assessed pre-implementation trends, immediate level changes, and post-implementation trends in the primary composite outcome. Multivariable logistic regression evaluated associations between insulin modality and the primary outcome. Surveys were analyzed by Wilcoxon rank-sum tests.</p><p><strong>Results: </strong>Of 1140 deliveries in the analytic cohort, the primary outcome occurred in 269 (23.6%). Rates were similar before and after protocol implementation (23.4% vs. 23.9%, <i>p</i> = 0.837). Interrupted time series analysis showed no significant pre-implementation trend, but did demonstrate a significant immediate reduction in monthly event rates at implementation (incidence rate ratio [IRR], 0.20; 95% confidence interval [CI], 0.04-0.90), with no significant post-implementation trend change (IRR, 1.03; 95% CI, 0.99-1.06). In adjusted analyses, insulin modality was not significantly associated with the primary outcome. RN satisfaction improved after implementation, with agreement or strong agreement increasing from 29.2% to 51.8% (<i>p</i> = 0.032).</p><p><strong>Conclusion: </strong>Implementation of an SC insulin-first intrapartum diabetes management protocol for patients with GDM and T2DM was not associated with increased neonatal hypoglycemia nor NICU admission for hypoglycemia. The protocol was associated with improved RN satisfaction. This approach may offer a pragmatic alternative to routine IV insulin initiation during labor.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 4","pages":"e70371"},"PeriodicalIF":0.0,"publicationDate":"2026-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hadley Ross, Casandra Chouravong, Ana Vera, Ariana Braddom, Adah Beck, Jan E Patterson, Angela Boyd
{"title":"Integrative medicine during antepartum hospitalization: A single-center retrospective pre-post study.","authors":"Hadley Ross, Casandra Chouravong, Ana Vera, Ariana Braddom, Adah Beck, Jan E Patterson, Angela Boyd","doi":"10.1002/pmf2.70372","DOIUrl":"https://doi.org/10.1002/pmf2.70372","url":null,"abstract":"<p><strong>Objective: </strong>Integrative medicine (IM) therapies are increasingly used alongside conventional medical care to address physical discomfort, stress, sleep disruption, and difficulty relaxing. However, IM remains understudied among hospitalized antepartum patients. We evaluated patterns of IM use and short-term changes in discomfort scores among hospitalized antepartum patients receiving IM consultation.</p><p><strong>Study design: </strong>We conducted a single-center retrospective pre-post study of antepartum patients admitted to a tertiary care center who received at least one IM consultation between January 2024 and July 2025. IM therapies included aromatherapy, meditation and breathwork, sound therapy, and relaxation techniques. Because IM consultations were provided at patient/provider request, the study population reflects patients selected for or interested in IM services rather than all hospitalized antepartum patients. Patient-reported discomfort was assessed immediately before and after each IM encounter by the IM nurse using a five-point ordinal scale from 0 to 4, with 0 indicating no discomfort and 4 indicating severe discomfort. For patients with multiple IM visits, only one paired pre/post discomfort score was included in the paired analysis, prioritizing the first IM visit with complete pre- and post-intervention discomfort scores. Encounters without both pre- and post-intervention discomfort scores were excluded from paired analysis. Paired scores were compared using the Wilcoxon signed-rank test.</p><p><strong>Results: </strong>A total of 207 antepartum patients received IM consultations during the study period, and 174 patients had paired pre- and post-intervention discomfort scores available for analysis. Mean gestational age at admission was 30 weeks, and median length of stay was 7 days. The most common admission indication was hypertensive disorders of pregnancy (31%). Aromatherapy (94%) and mind-body therapies, including meditation and breathwork (51%), were the most frequently used IM modalities. Median discomfort scores decreased from 2 before IM to 1 after IM (<i>p</i> < 0.0001). The median paired change was -1 (Interquartile range [IQR] -1 to 0). Discomfort scores decreased in 130 patients (75%), remained unchanged in 44 patients (25%), and none reported increased discomfort.</p><p><strong>Conclusion: </strong>Among hospitalized antepartum patients who received IM consultation, aromatherapy and mind-body therapies were the most frequently used modalities. IM encounters were associated with short-term reductions in patient-reported discomfort scores; however, given the pre-post design and the absence of a control group, these findings should be interpreted as hypothesis-generating rather than causal.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 4","pages":"e70372"},"PeriodicalIF":0.0,"publicationDate":"2026-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hiba J Mustafa, Jana Karam, William A Grobman, Kevin L Moss, Jasmine Johnson, Maged M Costantine, Heather A Frey, Moti Gulersen, Vincenzo Berghella, Alireza A Shamshirsaz
{"title":"Maternal nativity and preterm birth disparities in twin pregnancies: A nationwide population-based study.","authors":"Hiba J Mustafa, Jana Karam, William A Grobman, Kevin L Moss, Jasmine Johnson, Maged M Costantine, Heather A Frey, Moti Gulersen, Vincenzo Berghella, Alireza A Shamshirsaz","doi":"10.1002/pmf2.70361","DOIUrl":"https://doi.org/10.1002/pmf2.70361","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate whether maternal nativity (US born vs. non-US born) is associated with preterm birth (PTB) risk in individuals with twin pregnancies and to assess whether this association varies across racial and ethnic groups.</p><p><strong>Methods: </strong>This cross-sectional study used the National Center for Health Statistics and Centers for Disease Control and Prevention (CDC) natality dataset (2016-2023). This analysis included individuals aged 15-44 years with live-born twins residing in the United States. Maternal nativity (US born vs. non-US born) was stratified by race and ethnicity. Covariates included maternal age, education, insurance, prenatal care, smoking, prepregnancy body mass index, diabetes, hypertension, and year of birth. PTB (<37 weeks) was further categorized as extremely (<29 weeks), moderately (29-33weeks), and late (34-36 weeks). Binary and multinomial logistic regressions were used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (CIs).</p><p><strong>Results: </strong>Among 467,446 twin pregnancies, 282,754 (60.5%) were preterm. Of these, 191,972 (41.1%) were classified as late preterm (34 to <37 weeks), 68,457 (14.6%) as moderately preterm (29 to <34 weeks), and 22,325 (4.8%) as extremely preterm (<29 weeks). Non-US-born individuals had lower odds of PTB compared to US-born counterparts (aOR, 0.88; 95% CI, 0.86-0.89). The protective effect was strongest among non-US-born Black individuals (aOR, 0.65; 95% CI, 0.62-0.68). Across PTB subcategories, non-US-born individuals had reduced odds of extremely preterm (aOR, 0.85; 95% CI, 0.81-0.88), moderately preterm (aOR, 0.82; 95% CI, 0.80-0.84), and late PTB (aOR, 0.90; 95% CI, 0.88-0.92).</p><p><strong>Conclusions: </strong>Non-US-born individuals had lower odds of PTB compared to US-born individuals among twin pregnancies, extending prior findings from singleton populations to this high-risk group. These findings reinforce the role of nativity as an important social determinant of perinatal health. Future work should examine the mechanisms underlying these disparities and the influence of structural and cultural factors on twin birth outcomes.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 4","pages":"e70361"},"PeriodicalIF":0.0,"publicationDate":"2026-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Megan Stevenson, Melanie Maykin, Christine Carlos, Srishti Jayakumar, Danielle LoRe, Mina Sohrabi, Aunum P Akhter, Jasmine M Soo, Richard Kampanatkosol, Uchenna E Anani, Olivia Kammegne-Simo, Chondraah Holmes, Tiffany Tonismae, Mobolaji Famuyide, Kelly Yamasato
{"title":"Delayed interval delivery in multiple gestations at periviability-A multicenter retrospective cohort study.","authors":"Megan Stevenson, Melanie Maykin, Christine Carlos, Srishti Jayakumar, Danielle LoRe, Mina Sohrabi, Aunum P Akhter, Jasmine M Soo, Richard Kampanatkosol, Uchenna E Anani, Olivia Kammegne-Simo, Chondraah Holmes, Tiffany Tonismae, Mobolaji Famuyide, Kelly Yamasato","doi":"10.1002/pmf2.70366","DOIUrl":"https://doi.org/10.1002/pmf2.70366","url":null,"abstract":"<p><strong>Background: </strong>Delayed interval delivery (DID) is a rare strategy for preterm multiple gestations where delivery of the remaining fetus(es) is intentionally delayed following the delivery of the first infant, with the goal of improving outcomes for the retained fetus(es). Clinical outcome data remain limited due to the rarity of this scenario, which adds to the complexity of counseling patients who are considering DID.</p><p><strong>Objective: </strong>We sought to summarize obstetric care and neonatal outcomes in the setting of DID at periviability in a multicenter cohort.</p><p><strong>Study design: </strong>This multicenter retrospective cohort study analyzed data on periviable births (22w0d-24w6d) from 13 institutions between 2010 and 2020. From this cohort, we obtained cases of delayed interval deliveries where data were available for the retained twin. Management and outcome data were compiled for all viable fetuses. Deliveries were then stratified by the viability of Twin A at delivery and neonatal outcomes were compared between the Twin A and Twin B groups.</p><p><strong>Results: </strong>Thirteen pregnant persons and 20 infants from six institutions were included. All cases were dichorionic diamniotic twin gestations delivered from 2013 to 2019. The median intertwin delivery interval was 7 days (range: 29 h-5 weeks) and decreased as gestational age at delivery of Twin A increased. When both twins delivered in the periviable period, survival was 57.1% (4/7) for Twin A and 87.5% (7/8) for Twin B. In contrast, when Twin A delivered previable and Twin B delivered periviable, there were no survivors in either group. The intraamniotic infection (IAI) rate was 14.3% (1/7) in the Twin A group and 53.8% (7/13) in the Twin B group.</p><p><strong>Conclusion: </strong>This multi-institutional, contemporary periviable cohort suggests that when a clinically significant delivery interval is achieved, there may be neonatal benefit for the retained twin. However, DID is associated with a higher risk of IAI. These findings contribute to the limited data on DID at periviability and may assist clinicians in counseling patients in this complex scenario.</p>","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 4","pages":"e70366"},"PeriodicalIF":0.0,"publicationDate":"2026-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hiba J Mustafa, Yair J Blumenfeld, Ramen H Chmait, Jennifer L Taylor-Cousar, Jordana E Hoppe, Stacey L Martiniano, Angela Metcalf, Scott D Sagel, Edith T Zemanick, Alireza A Shamshirsaz, Sylvia E Szentpetery, Aaron T Trimble, Elizabeth B Burgener, Carmen Luna-Paredes, Isabelle Sermet-Gaudelus, Michael V Zaretsky
{"title":"Prenatal CFTR modulator therapy for fetal cystic fibrosis: Emerging evidence, clinical considerations, and future directions.","authors":"Hiba J Mustafa, Yair J Blumenfeld, Ramen H Chmait, Jennifer L Taylor-Cousar, Jordana E Hoppe, Stacey L Martiniano, Angela Metcalf, Scott D Sagel, Edith T Zemanick, Alireza A Shamshirsaz, Sylvia E Szentpetery, Aaron T Trimble, Elizabeth B Burgener, Carmen Luna-Paredes, Isabelle Sermet-Gaudelus, Michael V Zaretsky","doi":"10.1002/pmf2.70317","DOIUrl":"https://doi.org/10.1002/pmf2.70317","url":null,"abstract":"<p><strong>Background: </strong>The consequences of cystic fibrosis (CF) transmembrane conductance regulator (CFTR) protein dysfunction or absence begin during fetal development, with pancreatic, intestinal, hepatobiliary, and reproductive manifestations evident at birth. The advent of CFTR modulator therapies (CFTR modulator)-most notably elexacaftor/tezacaftor/ivacaftor (ETI), approved for children and adults with CF who carry responsive variants, and the recently approved vanzacaftor/tezacaftor/deutivacaftor (VTD), currently indicated for older pediatric and adult populations-has transformed long-term health outcomes and substantially increased the number of pregnancies among individuals with CF. As maternal use of CFTR modulator during pregnancy has become more common, early observational studies and case series suggest potential fetal benefit for fetuses affected by CF, particularly with respect to inspissated meconium obstructing the terminal ileum, potentially reducing the need for postnatal surgical intervention.</p><p><strong>Methods: </strong>To synthesize current evidence regarding maternal, fetal, and neonatal outcomes following prenatal CFTR modulator exposure; describe the rationale and early experience with intentional prenatal therapy for affected fetuses; and outline practical counseling and monitoring strategies. Evidence was drawn from clinical pregnancy cohorts, pharmacokinetic studies, case series treating fetal meconium ileus, mechanistic fetal and animal models, and expert consensus documents, including the PRenatal MOdulator Treatment to PrEvent CF ComplicaTions (PROTECT) Workshop summary. Both maternal- and fetal-indication uses of CFTR modulator were evaluated.</p><p><strong>Results: </strong>Continuation of ETI during pregnancy has been associated with stabilization of maternal pulmonary function and nutritional status and has not been linked to an increased risk of congenital anomalies, preterm delivery, or miscarriage in available observational cohorts. Both ETI and VTD cross the placenta and achieve fetal drug exposure at concentrations expected to be pharmacologically active. Case series in fetuses with CF describe improvement or resolution of prenatal bowel abnormalities indicative of evolving meconium ileus, with suggestive evidence of preservation of exocrine pancreatic function and the male reproductive tract in limited cases. Cataracts have rarely been reported, are typically small and not visually significant, and have not been consistently observed across cohorts. Prenatal exposure may result in falsely negative newborn screening results. However, the optimal timing and duration of prenatal modulator initiation for fetal benefit, fetal pharmacokinetics and pharmacodynamics, and long-term neurodevelopmental outcomes remain uncertain.</p><p><strong>Conclusion: </strong>Prenatal CFTR modulator therapy shows promise as the first fetal therapy for CF. While continuation for maternal CF is supported by available ev","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 4","pages":"e70317"},"PeriodicalIF":0.0,"publicationDate":"2026-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rebecca F Hamm, Anthony C Sciscione, Brett D Einerson, Matthew K Hoffman, Robert M Silver, Miriam J Alvarez, Alison G Cahill, Lisa D Levine
{"title":"Optimizing outpatient cervical ripening: A mixed-methods study identifying implementation drivers during a multisite, randomized trial.","authors":"Rebecca F Hamm, Anthony C Sciscione, Brett D Einerson, Matthew K Hoffman, Robert M Silver, Miriam J Alvarez, Alison G Cahill, Lisa D Levine","doi":"10.1002/pmf2.70360","DOIUrl":"https://doi.org/10.1002/pmf2.70360","url":null,"abstract":"<p><strong>Introduction: </strong>Data have demonstrated decreased time in the hospital and improved patient satisfaction when using outpatient cervical ripening with a Foley catheter as compared to routine in-hospital induction. An ongoing multisite trial (the COMFORT trial) is evaluating the impact of outpatient ripening on cesarean delivery, maternal and neonatal morbidity rates. Here, we aimed to characterize provider and organizational level determinants of implementation related to outpatient cervical ripening with a Foley catheter during the COMFORT trial.</p><p><strong>Methods: </strong>This sequential mixed-methods study (quan- > QUAL; December 2022 to January 2025) was embedded into an ongoing five-site randomized clinical trial comparing outpatient versus inpatient cervical ripening. Prior to trial initiation, surveys (quan) were distributed to obstetric clinicians at all sites. The survey collected demographics, Foley placement experience, perceived acceptability, and feasibility of outpatient Foley via validated measures [Likert; total 4-20]. One year into the trial, clinician focus groups (QUAL) assessed barriers, facilitators, and sustainability of outpatient Foley, guided by the Consolidated Framework for Implementation Research 2.0 and coded in an integrated approach.</p><p><strong>Results: </strong>A total of 396 clinicians (64% physicians, 22% nurses, 10% certified nurse midwives [CNMs], 4% nurse practitioners [NPs]/physician assistants [PAs]) completed the pre-trial survey; 29.2% had previously used outpatient ripening. Acceptability (19/20 interquartile range [IQR] [16-20]) and feasibility (16/20 IQR [15-20]) were high overall but varied by site (<i>p</i> = 0.003; <i>p</i> = 0.006, respectively). Factors independently associated with acceptability included site, clinician role (physicians/CNMs vs. nurses), and clinician gender. As a result, focus groups were divided by site and role to elicit site-specific barriers and facilitate open discussion among nurses without physicians/CNMs present. Twelve focus groups (<i>n</i> = 33) identified facilitators including belief in the evidence/safety and benefit, as well as leadership support. Barriers included concerns about timely hospital return, perceived patient discomfort, and operational constraints (e.g., space and staffing). In response, participants discussed systematic strategies to promote sustainability, several already enacted, such as standardized patient education and workflow solutions. No meaningful differences in identified barriers, facilitators, or suggested strategies were noted by site or clinician role.</p><p><strong>Conclusion: </strong>This work identified key determinants influencing the implementation of outpatient cervical ripening with a Foley catheter. Findings (1) allowed for real-time adaptations to intervention workflow and utilization of new implementation strategies during the course of the multisite trial, and (2) can be utilized to drive success for ","PeriodicalId":520540,"journal":{"name":"Pregnancy (Hoboken, N.J.)","volume":"2 4","pages":"e70360"},"PeriodicalIF":0.0,"publicationDate":"2026-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13624844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}