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Cesarean delivery is the most performed major surgery among women, and surgical-site infections following a cesarean delivery are a significant source of postoperative morbidity. It is unclear if vaginal cleansing before a cesarean delivery decreases post-cesarean delivery infectious morbidity.This study aimed to evaluate if preoperative vaginal cleansing with povidone-iodine among women undergoing a cesarean delivery after labor decreases postoperative infectious morbidity.This randomized clinical trial was conducted from August 3, 2015 to January 28, 2021, with 30 days of follow-up and the final follow-up completed on February 27, 2021. Patients met the inclusion criteria if they underwent a cesarean delivery after regular contractions with cervical dilation, rupture of membranes, or any cesarean delivery performed at4 cm dilation. Participants were randomly assigned in a 1:1 ratio to either abdominal cleansing plus vaginal cleansing with 1% povidone-iodine or abdominal cleansing alone. The primary outcome was composite infectious morbidity including surgical-site infection, fever, endometritis, and wound complications within 30 days after the cesarean delivery. Secondary outcomes included individual components of the composite, length of hospital stay, postoperative hospitalization or outpatient treatment related to infectious morbidity, and empirical treatment for neonatal sepsis.A total of 608 subjects (304 vaginal cleansing group, 304 control group) were included in the intention-to-treat analysis. Patient characteristics were similar between groups. There was no significant difference in the primary composite outcome between the 2 groups (11.8% vs 11.5%; P=.90; relative risk, 1.0; 95% confidence interval, 0.7-1.6). Individual components of the composite and secondary outcomes were also not significantly different between the groups. Similar findings were observed in the as-treated analysis (11.3% vs 11.8%; P=.9; relative risk, 1.0; 95% confidence interval, 0.7-1.6).Vaginal cleansing with povidone-iodine before an unscheduled cesarean delivery occurring after labor did not reduce the postoperative infectious morbidity. These findings do not support the routine use of vaginal cleansing for women undergoing a cesarean delivery after labor.

OBJECTIVE We tested the hypothesis that administration of vaginal progesterone in women with arrested preterm labor would result in lower rates of preterm birth

Objective There is wide variation in the management of pregnancies complicated by abnormal placental cord insertion (PCI), which includes velamentous cord insertion (VCI) and marginal cord insertion (MCI). We tested the hypothesis that abnormal PCI is associated with small for gestational age (SGA) infants. Study Design This is a retrospective cohort study of all pregnant patients undergoing anatomic ultrasound at a single institution from 2010 to 2017. Patients with abnormal PCI were matched in a 1:2 ratio by race, parity, gestational age at the time of ultrasound, and obesity to patients with normal PCIs. The primary outcome was SGA at delivery. Secondary outcomes were cesarean delivery, preterm delivery, cesarean delivery for nonreassuring fetal status, 5-minute Apgar score Results Abnormal PCI was associated with an increased risk of SGA (relative risk [RR]: 2.43; 95% confidence interval [CI]: 1.26–4.69), increased risk of preterm delivery Conclusion Abnormal PCI is associated with an increased risk of SGA and preterm delivery. These results suggest that serial fetal growth assessments in this population may be warranted. Key Points

To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity.This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1-5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP).Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P=.01), but less than the minimum important difference of 4.Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum.ClinicalTrials.gov, NCT02137200.

IMPORTANCE: Supplemental oxygen is commonly administered to pregnant women at the time of delivery to prevent fetal hypoxia and acidemia. There is mixed evidence on the utility of this practice. OBJECTIVE: To compare the association of peripartum maternal oxygen administration with room air on umbilical artery (UA) gas measures and neonatal outcomes. DATA SOURCES: Ovid MEDLINE, Embase, Scopus, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials were searched from February 18 to April 3, 2020. Search terms included labor or obstetric delivery and oxygen therapy and fetal blood or blood gas or acid-base imbalance. STUDY SELECTION: Studies were included if they were randomized clinical trials comparing oxygen with room air at the time of scheduled cesarean delivery or labor in patients with singleton, nonanomalous pregnancies. Studies that did not collect paired umbilical cord gas samples or did not report either UA pH or UA Pao(2) results were excluded. DATA EXTRACTION AND SYNTHESIS: Data were extracted by 2 independent reviewers. The analysis was stratified by the presence or absence of labor at the time of randomization. Data were pooled using random-effects models. MAIN OUTCOMES AND MEASURES: The primary outcome for this review was UA pH. Secondary outcomes included UA pH less than 7.2, UA Pao(2), UA base excess, 1- and 5-minute Apgar scores, and neonatal intensive care unit admission. RESULTS: The meta-analysis included 16 randomized clinical trials (n = 1078 oxygen group and n = 974 room air group). There was significant heterogeneity among the studies (I(2) = 49.88%; P = .03). Overall, oxygen administration was associated with no significant difference in UA pH (weighted mean difference, 0.00; 95% CI, −0.01 to 0.01). Oxygen use was associated with an increase in UA Pao(2) (weighted mean difference, 2.57 mm Hg; 95% CI, 0.80-4.34 mm Hg) but no significant difference in UA base excess, UA pH less than 7.2, Apgar scores, or neonatal intensive care unit admissions. Umbilical artery pH values remained similar between groups after accounting for the risk of bias, type of oxygen delivery device, and fraction of inspired oxygen. After stratifying by the presence or absence of labor, oxygen administration in women undergoing scheduled cesarean delivery was associated with increased UA Pao(2) (weighted mean difference, 2.12 mm Hg; 95% CI, 0.09-4.15 mm Hg) and a reduction in the incidence of UA pH less than 7.2 (relative risk, 0.63; 95% CI, 0.43-0.90), but these changes were not noted among those in labor (Pao(2): weighted mean difference, 3.60 mm Hg; 95% CI, −0.30 to 7.49 mm Hg; UA pH

The objective of this study was to evaluate maternal outcomes with an extended second stage of labor and determine if an extended second stage is cost effective. This theoretical model evaluated expectant management to 4 h compared to delivery at 3 h in the setting of a prolonged second stage of labor in nulliparous women with epidural analgesia. In our theoretical cohort of 165,000 women, we found that an extended second stage resulted in 53,268 more spontaneous vaginal deliveries, 14,163 fewer operative vaginal deliveries, and 39,105 fewer cesarean deliveries. This approach also resulted in 1 fewer instance of maternal death. An extended second stage, however, led to 14,025 more cases of chorioamnionitis, 1699 more episodes of postpartum hemorrhage requiring transfusion, and 119 more severe perineal lacerations, suggesting that while an extended second stage of labor results in overall improved maternal outcomes, there are tradeoffs. Expectant management to 4 h was the dominant strategy in the model, as it saved over $114 million US dollars and resulted in 4000 additional QALYs over our theoretical cohort. Sensitivity analysis indicated that expectant management until 4 h was cost-effective as long as the probability of cesarean delivery at 4 h was below 41.8%, and was the dominant strategy below 38.2% (baseline input: 19.5%). Multivariable sensitivity analysis demonstrated that the model was robust over a wide range of assumptions. Expectant management of the second stage of labor until 4 h is a cost-effective strategy to prevent primary cesarean deliveries, decrease costs, and improve some maternal outcomes, despite tradeoffs.

OBJECTIVES To assess the role of the cerebro-placental ratio (CPR) in predicting adverse fetal outcomes among women with sickle cell disease (SCD). METHODS A prospective cohort study at Korle-Bu Teaching Hospital, Accra, Ghana, between January and June 2016. Pregnant women with SCD at 34 gestational weeks or more underwent weekly fetal umbilical and middle cerebral artery Doppler assessment until delivery. Participants were categorized into two study arms based on CPR (

Preterm birth, defined as delivery at less than 37 weeks' gestation, increases maternal-fetal morbidity and mortality and places heavy financial and emotional burdens on families and society. Although premature cervical remodeling is a major factor in many preterm deliveries, how and why this occurs is poorly understood. This review describes existing and emerging imaging techniques and their advantages and disadvantages in assessing cervical remodeling. Brightness mode (B-mode) ultrasound is used to measure the cervical length, currently the gold standard for determining risk of preterm birth. Several new B-mode ultrasound techniques are being developed, including measuring attenuation, cervical gland area, and the cervical consistency index. Shear wave speed can differentiate between soft (ripe) and firm (unripe) cervices by measuring the speed of ultrasound through a tissue. Elastography provides qualitative information regarding cervical stiffness by compressing the tissue with the ultrasound probe. Raman spectroscopy uses a fiber optic probe to assess the biochemical composition of the cervix throughout pregnancy. Second harmonic generation microscopy uses light to quantify changes in collagen fiber structure and size during cervical maturation. Finally, photoacoustic endoscopy records light-induced sound to determine optical characteristics of cervical tissue. In the long term, a combination of several imaging approaches, combined with consideration of clinical epidemiologic characteristics, will likely be required to accurately predict preterm birth.

Introduction: Complication rates associated with peripherally inserted central catheters (PICCs) in the general population are variable, and rates specific to pregnant women are unclear. We conducted a systematic review and meta-analysis to estimate the rate of PICC-associated complications in pregnant women.Methods: We searched published literature for records discussing PICC use in pregnant or postpartum women. We included studies with primary data regarding rates of maternal complications from PICC use. The primary outcomes were maternal infection (cellulitis, sepsis), venous thromboembolism (VTE), or combined major complication rate. Secondary outcomes were superficial thrombophlebitis or mechanical failure. Meta-analysis was performed using STATA 12 with the METAN and METAPROP software routines. Pooled estimates with 95%CI were calculated using random-effects models.Results: After the removal of duplicates, the primary search yielded 318 articles, with 5 being included for final analysis. The pooled rate of combined infectious and thromboembolic complications was 26% (95%CI = 6-53%). For secondary outcomes the pooled rate of infectious complications was 18% (95%CI = 4-39%), VTE 6% (95%CI = 0-18%), mechanical failure 7% (95%CI = 3-12%), and superficial thrombophlebitis 1% (95%CI = 0-3%). There was significant statistical heterogeneity between studies for all outcomes calculated.Conclusion: There are limited data regarding complication rates due to PICC use in pregnancy, with a high level of heterogeneity among existing studies. The risk of VTE appears comparable to PICC-associated VTE in the non-pregnant hospitalized population. The risk of infection associated with PICC use was the most variable, with rates ranging from 4% to 37%. This suggests that infection risk may be modifiable and further studies are needed to assess interventions that may lower this risk.

OBJECTIVE Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. STUDY DESIGN This open-label RCT randomized patients with IDA (hemoglobin [hgb]

Objective To investigate the association between large-for-gestational-age (LGA) pregnancy and stillbirth to determine if the LGA fetus may benefit from antenatal testing with non-stress test or biophysical profile. Methods This was a retrospective cohort study of singleton pregnancies that were ongoing at 24 weeks' gestation and that had undergone routine second-trimester anatomy ultrasound examination, during the period 1990 to 2009. Pregnancies complicated by fetal anomaly or aneuploidy, those with missing birth weight information and those that were small-for-gestational age were excluded. Appropriate-for-gestational age (AGA) and LGA were defined as birth weight between the 10th and 90th percentiles and > 90th percentile, respectively, according to the Alexander growth standard. The incidence of stillbirth was calculated as the number of stillbirths per 10 000 ongoing pregnancies. Adjusted odds ratios (aOR) with 95% CI for stillbirth in LGA compared with AGA pregnancies were estimated using logistic regression analysis, controlling for pre-existing and gestational diabetes. The incidence and aOR for stillbirth were estimated at 4-week intervals from ≥ 24 to ≥ 40 weeks' gestation. Results Of 52 749 pregnancies ongoing at 24 weeks, 46 205 (87.6%) were AGA and 6544 (12.4%) were LGA at delivery. The incidence of stillbirth in LGA pregnancies was significantly higher than that in AGA pregnancies from 36 weeks' gestation (26/10 000 vs 7/10 000; aOR, 3.10; 95% CI, 1.68-5.70). When women with diabetes were excluded in stratified analysis, pregnancies complicated by LGA continued to be at increased risk for stillbirth ≥ 36 weeks (18/10 000 vs 7/10 000; OR, 2.63; 95% CI, 1.27-5.43). Conclusion Pregnancies complicated by LGA are at significantly increased risk for stillbirth at or beyond 36 weeks, independent of maternal diabetes status, and may benefit from antenatal testing. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

OBJECTIVES To evaluate the effect of parity on performance characteristics of midtrimester cervical length (CL) in predicting spontaneous preterm birth (sPTB) before 37 weeks. METHODS This was a retrospective cohort study of 13,508 women with no history of sPTB undergoing universal transvaginal CL screening at 17 to 23 weeks' gestation from 2011 to 2016. Patients who declined screening or with unknown delivery outcomes were excluded. Areas under the receiver operator characteristic curves were used to assess and compare the predictive ability of CL screening for sPTB. The sensitivity, specificity, and positive and negative predictive values were estimated for specific CL cutoffs for prediction of sPTB. RESULTS There were 20,100 patients, of whom 2087 (10%) declined screening and 4505 (22%) did not meet inclusion criteria. Of the remaining 13,508 patients, 43% were nulliparous. The incidence rates of sPTB were 6.5% in nulliparas and 4.9% in multiparas (P

Objective: To analyze perinatal morbidity and stillbirth after intrauterine growth restriction (IUGR) with an umbilical artery Doppler pulsatility index (UA PI) less than the fifth centile.Study de...

Objective: To estimate the prevalence and characteristics of fetal thrombocytopenia at the time of percutaneous umbilical cord sampling (PUBS) in pregnancies complicated by alloimmunization and to conduct a systematic review on fetal thrombocytopenia in these pregnancies. Study Design: Retrospective cohort study of all patients undergoing PUBS at our institution from 2000–2017. Clinical data including fetal platelet counts were abstracted from the medical record and analyzed with routine statistical procedures. A systematic review and metaanalysis were also conducted according to standard procedures. Result: At first procedure, prior to any transfusion, 13/36 fetuses (36%) had thrombocytopenia: 11/36 (31%) had moderate thrombocytopenia, and 2/36 (6%) had severe thrombocytopenia (14 patients had no platelet count at first procedure). The systematic review identified six studies, and the prevalence of fetal thrombocytopenia at the time of PUBS for alloimmunization was 18% (95% confidence interval 11%, 26%). Conclusion: Thrombocytopenia is common and underappreciated in fetuses undergoing PUBS for alloimmunization.

Pregnancy and childbirth are known risk factors associated with the development of pelvic organ prolapse; specific intrapartum risk factors are not well characterized.This study aimed to determine intrapartum factors associated with increased risk of pelvic organ prolapse identified after delivery.A planned secondary analysis of a multicenter randomized clinical trial of delayed vs immediate pushing among nulliparous women at ≥37 weeks of gestation in labor with neuraxial analgesia was conducted at 6 academic and community hospitals in the United States. Intrapartum characteristics were identified, and Pelvic Organ Prolapse Quantification assessments at 6 weeks and 6 months after delivery were performed. The primary outcome was pelvic organ prolapse, defined as stage 2 or greater prolapse using the Pelvic Organ Prolapse Quantification assessment at 6 months. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, macrosomia, and maternal age.Among the 941 women participating in the pelvic floor follow-up, 793 women had Pelvic Organ Prolapse Quantification assessments at 6 weeks with 91 of 793 women (11.5%) demonstrating stage 2 or greater prolapse. Of the 728 women followed up at 6 months, stage 2 or greater prolapse was identified in 58 of 728 women (8.0%). Prostaglandin use for induction of labor was associated with an increased risk at 6 months (adjusted odds ratio, 2.15; 95% confidence interval, 1.18-3.91; P.01). The length and type (spontaneous vs induced) of the first stage of labor were not significantly associated with stage 2 or greater prolapse. Moreover, increased length of the second stage of labor and duration of pushing were not associated with stage 2 or greater prolapse. After adjusting for confounding factors, cesarean delivery was protective of pelvic organ prolapse at 6 months (adjusted odds ratio, 0.12; 95% confidence interval, 0.02-0.90).The management of the first and second stages of labor, including time length, was not associated with stage 2 or greater prolapse at 6 months. The findings that prostaglandin exposure was associated with increased risk likely were not directly affecting the risk of prolapse but may be surrogates for other labor features that deserve exploration. Cesarean delivery was associated with protection from stage 2 or greater pelvic organ prolapse at 6 months, consistent with previous literature.

Recommendations from the American College of Obstetricians and Gynecologists for the safe prevention of primary cesarean deliveries propose that cesarean delivery for active phase arrest in the first stage of labor should be performed only if women fail to progress despite four hours of adequate uterine activity and no cervical change. This is a change in recommendation from a two-hour threshold.To determine the economic and clinical implications of waiting four hours compared to two hours for cervical progression before diagnosing active phase labor arrest.We designed a cost-effectiveness analysis using TreeAge Pro 2020 software with model inputs derived from the literature. We used a theoretical cohort of 1.4 million women, the approximate number of nulliparous U.S. women reaching four centimeters in spontaneous labor. We compared maternal and neonatal outcomes and costs associated with defining active phase arrest after four hours of no cervical progression versus two hours. As a baseline assumption, active labor was defined at four centimeters. It was assumed that women with active phase arrest were deliveredIn a theoretical cohort of 1.4 million women, waiting four hours instead of two hours led to 322,253 fewer cesarean deliveries, 6 fewer maternal deaths, 123 fewer postpartum hemorrhages requiring transfusions, and 28,615 fewer episodes of endometritis. There were 418 more instances of neonatal shoulder dystocia and 14 more cases of permanent brachial plexus injuries with a four-hour threshold. A four-hour threshold leads to 56% more women having a vaginal delivery in our theoretical cohort. Results from our model show that waiting four hours versus two hours to diagnose active phase labor arrest led to increased total QALYs with increased costs, with an incremental cost effectiveness ratio (ICER) below our willingness-to-pay threshold of $100,000 per QALY. Thus, it was cost effective to wait for at least four hours in the diagnosis of active phase arrest. Multivariable sensitivity analysis demonstrated the model was robust over a wide range of assumptions.Increasing the time threshold from two to four hours for diagnosing active phase labor arrest beyond four centimeters is a cost-effective strategy, resulting in fewer primary cesarean deliveries and improved maternal outcomes, despite a small increase in adverse neonatal outcomes.

IMPORTANCE: Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women. OBJECTIVE: To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019. INTERVENTIONS: Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808). MAIN OUTCOMES AND MEASURES: The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions. RESULTS: Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, −1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, −0.53%; 95% CI, −1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, −0.27%; 95% CI, −2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P

Intrauterine vacuum-induced hemorrhage control may provide an effective treatment option for postpartum hemorrhage that has the potential to prevent severe maternal morbidity and mortality., OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: A multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88–98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0–5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1–3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.

Objective This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. Study Design A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. Results Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p Conclusion Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. Key Points