Neonatal Birth Weight With Daily Compared With Every-Other-Day Glucose Monitoring in Gestational Diabetes Mellitus: A Randomized Controlled Trial.

OBJECTIVE: To assess whether universal use of every-other-day glucose monitoring in patients with gestational diabetes mellitus (GDM) resulted in similar birth weights and medication use and was preferred by the patient compared with traditional daily glucose monitoring. METHODS: This was a noninferiority randomized controlled trial conducted at a single New York City hospital between April 2021 and May 2022. Patients with singleton pregnancies who were diagnosed with GDM after 20 weeks of gestation and had a minimum of 7 days of previous daily blood glucose testing were randomly assigned to test blood glucose values daily or every other day. The primary outcome was neonatal birth weight. We calculated a total sample size of 196 participants needed for noninferiority to be tested, assuming the mean birth weight in the every-other-day group, compared with the daily group, was no higher than the predefined noninferiority margin of 200 g (80% power and one-sided alpha of 0.05). Postrandomization characteristics, including blood glucose values and medication initiation and timing, were recorded. Satisfaction with treatment group was assessed using the validated Oxford Maternity Diabetes Treatment Satisfaction Questionnaire. RESULTS: A total of 197 patients were randomized: 98 in the daily group and 99 in the every-other-day group. Baseline characteristics were similar between groups. The mean neonatal birth weight was similar between groups (mean±SD 3,090±418 g among newborns in the daily group compared with 3,181±482 g among newborns in the every-other-day group). For the primary outcome, the every-other-day group was found to be noninferior to the daily group with an upper confidence limit for the mean difference in mean birth weight of 197 g, which was below the noninferiority margin of 200 g (P=.046). Postrandomization, there were no significant differences in the number of patients who required medication, the gestational age at which medication was started, or the type of medication used. Average fasting and postprandial glucose values were similar between groups. There was an increase in adherence to treatment group in those randomized to every-other-day blood sugars, but no difference in patient satisfaction. CONCLUSION: In patients with GDM, testing blood glucose values every other day was as effective as testing daily, without apparent effects on birth weight, medication initiation, or glucose control. Reduced frequency of blood glucose monitoring might help decrease the emotional, physical, and financial burden experienced by patients with GDM. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04857073.

Barriers to completion of expanded carrier screening in an inner city population.

PURPOSE: The American College of Medical Genetics and Genomics emphasizes a "consistent and equitable approach for offering carrier screening." At our academic center, publicly insured prenatal patients underwent universal expanded carrier screening (ECS) to promote equitable care. The aim of the study was to evaluate rates, time, and barriers to complete ECS. This was defined as post-test counseling and partner testing after a patient was found heterozygous for a pathogenic variant. METHODS: In this descriptive retrospective cohort study from 2018 to 2021, patients were offered ECS, consisting of 283 recessive and X-linked genes. Heterozygotes were contacted by genetic counselors (≤5 attempts) for education and partner testing. Rates of counseling, partner testing, diagnostic procedures, follow-up times, and barriers to completion were assessed. RESULTS: During this time, 643 women underwent ECS. Of these 643 women, 462 were heterozygotes and 326 of 462 had undergone counseling. Two hundred twenty-two of 462 partners obtained testing, with a median of 32 days from patient to partner result. Approximately 21 couples were heterozygous for the same pathogenic variant. One patient pursued diagnostic testing. CONCLUSION: ECS offers useful information; however, this study highlights significant barriers to completion. There was suboptimal patient follow-up and low partner screening, perhaps from insufficient time to educate and counsel. Future directions include implementing quality measures to ensure optimal completion.

Comparison of an Intermittently Scanned (Flash) Continuous Glucose Monitoring System to Standard Self-Monitoring of Capillary Blood Glucose in Gestational Diabetes Mellitus.

OBJECTIVE: Gestational diabetes mellitus (GDM) requires close surveillance of blood glucose to prevent perinatal morbidity. Self-monitoring of capillary blood glucose (BGM) comes with considerable psychosocial burden. Intermittently scanned continuous glucose monitor (isCGM) devices are discreet and could considerably impact the lifestyle of the patient. They are designed to replace BGM testing in nonpregnant patients. Data on this technology in pregnancy are scant. The aim of this study was to assess concordance of BGM with isCGM in GDM. STUDY DESIGN: Institutional review board approved prospective single-arm study evaluating agreement of isCGM (Freestyle Libre 14-day system) compared with BGM when determining glucose levels fasting and 2-hour postprandial for 14 days. This was documented as percentage of results within Zone A (clinically accurate measurements with no effect on clinical action) or Zone B (values that deviate from reference by >20% but would lead to benign/no treatment) of the Parkes Error Grid (developed for nonpregnant patients with diabetes). Per International Organization for Standardization criteria, agreement was defined as >95% within Zone A or B. Analytical agreement was evaluated using mean and median absolute relative difference (ARD), mean and median absolute difference (AD). RESULTS: There were 1,604 pairs of BGM/isCGM observations for 41 patients. Mean glucose values were 102.0 (standard deviation [SD] = 20.5) and 89.4 (SD = 20.1) mg/dL for BGM and isCGM, respectively. Mean and median AD were 15.9 and 13.0 mg/dL, respectively. Mean and median ARD were 15.9 and 12.5%, respectively. Zones A and B contained 76.9 and 22.9% of values, respectively, in the Parkes Error Grid, for a total of 99.8%. CONCLUSION: BGM and isCGM demonstrate clinical agreement. However, glucose values with isCGM trended lower, with greater mean and median ARD than prior studies. Given the strict glycemic control required during pregnancy, physicians should be aware of these differences and their possible clinical implications. KEY POINTS: · Gestational diabetes mellitus requires close surveillance of blood glucose.. · isCGM is painless and discreet; however, values trend lower than capilary blood glucose.. · Physicians should be aware of these differences and possible clinical implications..

Incidentally Found Midtrimester Shortened Cervical Length: Practice Patterns among American Maternal-Fetal Medicine Specialists.

OBJECTIVE: The management of incidentally found short cervical length (CL) without prior spontaneous preterm birth (PTB) can vary. While most agree on starting vaginal progesterone, management after CL shortens <10 mm varies. The purpose of this study was to elucidate current practice patterns amongst maternal-fetal medicine (MFM) specialists. STUDY DESIGN: We conducted an online survey of MFM attending physicians and fellows in the United States from May 2019 to April 2020. The primary outcome was management of varying CL based on gestational age. Variations in management were assessed descriptively. RESULTS: There were 236 respondents out of 400 eligible surveyed, with a response rate of 59.2%. Universal CL screening was reported by 93.6% (49.6% abdominal and 44.1% transvaginal). Management of short CL varied based on CL measurement, rather than gestational age at presentation. At CL <10 mm, management included cerclage (17.4-18.7%), vaginal progesterone (41.3-41.7%), or cerclage plus vaginal progesterone (43.4%). Between CL of 10 to 20 mm, the majority (77.4-91.9%) would start vaginal progesterone. At CL 21 to 25 mm, management varied between expectant management (45.5-48.5%) or vaginal progesterone (51.1-52.8%). Suture material used was ethylene terephthalate (47.4%) or polypropelene (31.2). Preoperative antibiotic use was reported by 22.3%, while 45.5% used them only if the amniotic membranes were exposed, and 32.2% reported no antibiotic use. Postoperative tocolytic use varied with 19.3% reporting no use, 32.6% using it always, 8.2% only after significant cervical manipulation, 22.7% after the patient is experiencing symptoms, and 17.6% using it only if the cervix is dilated on exam. After cerclage placement, 44.5% continued CL surveillance. CONCLUSION: Substantial differences of opinion exist among MFM physicians regarding management of incidentally found short CL in patients without history of PTB. The differences in responses obtained highlight the need for evidence-based guidelines for managing this clinical scenario. KEY POINTS: · There is lack of consensus on the management of incidentally found shortened CL.. · The purpose of this study was to elucidate current trends in CL screening and management.. · Substantial differences of opinion exist regarding management of incidentally found short CL..

Opening Pandora's box: abnormal genetic carrier screening and need for lifetime follow-up.

OBJECTIVE: Expanded carrier screening (ECS) is rising in popularity because of its application in a diverse population, its decreasing cost, and efficiency.1 However, it has traditionally been used to assess fetal risk. The next generation sequencing ECS panel offered at our academic medical center consists of 283 genes associated with hereditary disorders. Of those, 20 (7.1%) are autosomal recessive conditions, notable for variable expression of the clinical phenotype in heterozygous carriers, which may increase maternal risk for malignancy, bleeding, cardiovascular, or rheumatologic disease. Another 21 (7.4%) are X-linked conditions. We aimed to evaluate the prevalence of variants that have a potential for maternal phenotypic expression and whether identification of specific variants prompted patients to pursue further care in our health system, namely comprehensive genetic counseling and further healthcare consults when recommended. STUDY DESIGN: An institutional review board-approved descriptive retrospective cohort study was performed in a New York City academic medical center at which reproductive aged women were offered universal ECS from 2018 to 2021 by their provider, inclusive of obstetrician-gynecologists, maternal-fetal medicine physicians, and genetic counselors. Pretest counseling was performed by the ordering provider. Patients found to carry mutations with the potential for maternal phenotypic expression were contacted by genetic counselors regarding their clinical risks. In addition, patients who were carriers for factor XI deficiency, Bernard Soulier syndrome, ataxia telangectesia, fumarase deficiency, Nijmegen breakage syndrome, Duchenne muscular dystrophy, and familial hypercholesterolemia were advised to seek specialized healthcare pertaining to their clinical risk. The genetic counseling summary was placed in the electronic medical records (EMRs) so that the primary provider could view the findings. Through our EMRs, we evaluated the rates of healthcare uptake among these patients for at least 1 year after delivery. RESULTS: In total, 168 of 1184 (14.2%) patients were identified as carriers of mutations with a potential for maternal phenotypic expression. Of these, 156 (93%) were pregnant and 12 (7%) were preconception. Of those patients, 143 (85%) were carriers of autosomal recessive traits (Figure 1), whereas 22 of 168 (13%) patients were carriers of X-linked conditions (Figure 2) and 3 of 168 (2%) patients carried both autosomal recessive traits and X-linked conditions. Of these carriers, 132 of 168 (78.6%) patients underwent genetic counseling. The most common heterozygous mutations were sickle cell trait (25.6%), thalassemia (alpha and/or beta) trait (14.2%), factor XI deficiency (4.7%), dystrophic epidermolysis bullosa (4.2%), and Alport syndrome (4.1%). Two patients were diagnosed as homozygous carriers of nonclassical congenital adrenal hyperplasia. During the study period, 23 of 168 (13.6%) patients were heterozygous for specific pathogenic variants (inclusive of factor XI, Bernard Soulier syndrome, ataxia telangectesia, fumarase deficiency, Nijmegen breakage syndrome, Duchenne muscular dystrophy, and familial hypercholesterolemia) and were advised to seek specialized healthcare pertaining to these findings. Of these, 20 (87.0%) received genetic counseling with standardized recommendations, however, only 4 of 23 (17%) patients pursued the recommended referrals during our study period. CONCLUSION: This study described the follow-up rates among patients identified as carriers of conditions with the potential for maternal phenotypic expression using ECS. We observed that 14.2% of patients who underwent ECS were identified as carriers of genetic mutations with the potential for maternal phenotypic expression, and of the 23 who were recommended specific care because a pathogenic variant was identified, only 17.4% of patients followed the recommendations. We believe that as ECS implementation becomes widespread, more maternal carriers with clinical risk to themselves will be identified. Therefore, as we open this Pandora's box, the burden of counseling and follow-up must be addressed.

Resolved but Not Forgotten: The Effect of Resolved Placenta Previa on Labor Management.

OBJECTIVES: Placenta previa is diagnosed in up to 15% of pregnancies at the anatomy ultrasound and 0.5% persist to term. There is limited data regarding pregnancy outcomes with resolved previa. We aimed to examine patients with resolved placenta previa to determine if abnormal placentation at any time during pregnancy is associated with adverse events during labor. STUDY DESIGN: Patients with placenta previa were identified after second trimester ultrasound, included if placenta previa resolved with the placental edge greater than 2 cm from the internal cervical os, and excluded if placenta previa persisted to term, resolution occurred prior to 20 weeks, patients underwent a prior cesarean delivery, or delivered at an outside institution. Time-matched controls were identified among patients with normal placental location. Demographic data and outcomes were collected. Student's t-test, Wilcoxon's rank-sum test, Chi-square, Fisher's exact test, and univariable and multivariable logistic regression were used as appropriate RESULTS: Overall, 560 patients had placenta previa, 275 had resolved placenta previa, 285 were excluded. Resolved placenta previa patients were significantly older with lower prepregnancy body mass index (BMI), were significantly more likely to be a current smoker, have used assisted reproductive technology, and have had previous uterine surgeries. Overall, 10.2% of patients with resolved placenta previa experienced postpartum hemorrhage, compared with 2.1% in the normal placentation group. Patients with resolved placenta previa were 5.2 times more likely to have a postpartum hemorrhage (odds ratio [OR] = 5.2, 95% confidence interval [CI]: 2.1-12.7; p < 0.01) and 3.4 times more likely to require extra uterotonic medications (OR = 3.4, 95% CI: 1.9-6.2; p < 0.01). There is no difference with regard to rates of operative delivery for fetal distress (OR = 1.2, 95% CI: 0.7-1.9; p = 0.48), or category-II or-III fetal heart tracing around the time of delivery. CONCLUSION: Patients with resolved placenta previa had a higher rate of postpartum hemorrhage and use of uterotonic agents. This information might have important clinical implications and could be incorporated into the hemorrhage risk assessment during labor. KEY POINTS: · This study aimed to determine if patients with resolved placenta previa had an increased risk of expedited delivery due to fetal distress during labor.. · Patients age with resolved placenta previa have similar risk factors to those with persistent placenta previa, including older maternal, lower prepregnancy BMI, current smoking status, use of assisted reproductive technology (ART) and history of previous uterine surgeries. They were not at increased risk for operative vaginal delivery or cesarean section due to fetal distress. They did require increased uterotonic use and were at an increased risk for postpartum hemorrhage. · Patients with resolved placenta previa should undergo hemorrhage precautions at the time of admission..

A Case of Markedly Elevated Isolated Alkaline Phosphatase in the Third Trimester of Pregnancy.

Background: Alkaline phosphatase (ALP) is an enzyme produced by the liver, small intestine, bone, and kidneys as well as the placenta during pregnancy. ALP levels may increase up to twice the normal limit during pregnancy secondary to placental release and fetal bone growth. Rare case reports of extremely elevated levels of ALP during pregnancy have demonstrated possible association with adverse pregnancy outcomes. Case: The patient is a 36-year-old G2P1001 who was found to have extremely elevated ALP levels during pregnancy after presenting with bilateral lower leg swelling and rash after receiving the Pfizer COVID-19 vaccine. She subsequently developed intrahepatic cholestasis of pregnancy and preeclampsia. ALP peaked at 2,601 U/L immediately prior to delivery at 36 weeks 1 day. She was followed postpartum, and her ALP levels had nearly normalized by 15 weeks postpartum. Conclusion: Our case demonstrates a rare report of an extremely elevated level of ALP in the setting of multiple adverse pregnancy outcomes, including preterm delivery, preeclampsia without severe features, and intrahepatic cholestasis of pregnancy.

The role of the first trimester screen in the face of normal cell free DNA.

OBJECTIVE: There is no consensus for the method of aneuploidy screening in pregnancy. Cell free DNA (cfDNA) is the most sensitive screen for trisomies 21, 13, and 18, however the first trimester screen (FTS) is a marker for other adverse outcomes, such as structural anomalies, growth restriction, and preeclampsia. In 2019, we offered FTS (nuchal translucency (NT) and analytes) with or without cfDNA. The purpose of this study was to assess clinical relevance of abnormal FTS in women with normal cfDNA. METHODS: We retrospectively reviewed women undergoing screening in our Fetal Evaluation Unit in 2019. Women included had normal cfDNA and abnormal FTS; consisting of NT >95%, PAPP-A < 0.4 MoM, beta-HCG >2.5 MoM, or overall increased risk of trisomies. RESULTS: 195 patients had abnormal FTS and normal cfDNA. 41 (21%) had adverse maternal outcomes including hypertension, abnormal placentation, and placental abruption. 34 (17%) had adverse fetal outcomes including growth restriction, structural anomalies, fetal demise, polyhydramnios, previable PPROM, necrotizing enterocolitis after a preterm birth, and a balanced translocation. CONCLUSION: Abnormal FTS predicts adverse outcomes in 33% of women with normal cfDNA. Our data suggests that offering universal FTS with cfDNA may have clinical benefit.

Mirror syndrome in monochorionic diamniotic twins presenting as maternal hyponatremia: A case report.

This is a case report of a 39-year-old patient, G5P1031, with monochorionic diamniotic twins at 30 weeks and 1 day of gestation, who developed mirror syndrome without twin-to-twin transfusion syndrome (TTTS) with a unique presentation of maternal and neonatal hyponatremia. Coinciding with severe hyponatremia were maternal symptoms of edema, nausea and vomiting, hypoalbuminemia, elevated uric acid, as well as fetal selective growth restriction, polyhydramnios, umbilical artery absent end diastolic flow and prolonged bradycardia of twin B. Given the poor status of twin B and the risks to twin A, the patient underwent emergent cesarean delivery. Hyponatremia in all three patients resolved in the following 48-72 h. Mirror syndrome is associated with significant maternal and fetal morbidity and mortality. In this case, severe hyponatremia posed additional risks. Therefore, electrolyte monitoring should be considered in both mother and neonate(s).

What Is the Prevalence of Measles Immunity among Pregnant Women?

OBJECTIVE: This study aimed to estimate the prevalence of measles immunity in a cohort of pregnant women in New York City and determine if there is a positive correlation of measles immunity with patient demographics, rubella immunity, number of measles, mumps, and rubella vaccine (MMR) doses received, and age at last vaccination. STUDY DESIGN: This is a cross-sectional study of pregnant patients seen at a single institution from January 2019 to May 2019. Patients were classified as measles and rubella immune or nonimmune using commercial immunoglobulin G (IgG) tests. Patient characteristics were compared using t-tests, Chi-square tests, or Fisher's exact tests as appropriate. The association of age at last vaccination with immunity status was assessed using multivariable logistic regression adjusted for age at presentation. The utility of rubella IgG for distinguishing measles immunity was assessed using receiver operating characteristic curve analysis. RESULTS: Serologic immunity for measles and rubella was obtained for 1,366 patients. Of these, 1,047 (77%) were measles immune and 1,291 (95%) were rubella immune. Patients born after 1989 were less likely to be immune to measles, while multiparity and private insurance were associated with increased measles immunity. Documentation of MMR vaccination was available for 140 (10%) patients. Of these, 44 (31%) were serologically nonimmune to measles and 9 (6.4%) were nonimmune to rubella. In patients known to have received one dose of MMR, 62% (24/39) were immune to measles with an improvement to 72% (69/96) among those who received two or more doses. Age at last vaccination was not associated with measles immunity. Rubella IgG level was a poor predictor of positive measles titer (area under the curve = 0.59). CONCLUSION: Approximately one of every four pregnant patients is serologically measles nonimmune, even among women with documented MMR vaccination or documented rubella immunity. These findings raise concerns that relying on vaccination history or rubella immune status may not be sufficient to assure protection from infection with measles. If further suggests that measles serology should be added to routine prenatal laboratory testing to identify nonimmune patients that may benefit from postpartum vaccination. KEY POINTS: · Approximately one of every four pregnant patients were serologically measles nonimmune.. · Rubella immunoglobulin G was a poor predictor of measles immunity status.. · Measles serology should be added to routine prenatal laboratory testing..

The Accuracy of Group Beta Streptococcus Rectovaginal Cultures at 35 to 37 Weeks of Gestation in Predicting Colonization Intrapartum.

Objective This study aims to investigate accuracy of group beta Streptococcus (GBS) rectovaginal cultures at 35 to 37 weeks in predicting intrapartum colonization. Study Design Institutional review board (IRB) approved prospective cohort study of 302 women from October 2015 to May 2017. Patients had the following tests for GBS: first trimester urine culture, rectovaginal culture at 35 to 37 weeks, and intrapartum rectovaginal culture. Outcomes included accuracy of 35- to 37-week GBS rectovaginal culture in detecting results intrapartum, and accuracy of first trimester urine culture in comparison to intrapartum rectovaginal cultures. Results There was sufficient evidence of agreement between results at 35 to 37 weeks with intrapartum cultures ( p = 0.001). However, agreement was weak, 11 patients (3.7%) were GBS positive intrapartum but negative at 35 to 37 weeks; and 33 patients (11%) were initially GBS positive but were negative intrapartum. Sensitivity and specificity of the 35- to 37-week culture was 69% (95% confidence interval [CI]:54-84%) and 87% (95% CI: 83-91%), respectively. There was also weak agreement between first trimester urine culture and intrapartum rectovaginal culture. Specificity for this assessment was 98% (95% CI: 97-100%) and was significantly different compared with antepartum GBS culture ( p < 0.001). Accuracy between antepartum GBS rectovaginal culture and urine culture was similar (85 vs. 87%, p = 0.47). Conclusion The 35- to 37-week GBS rectovaginal culture might be a poor predictor for intrapartum colonization.

Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial.

OBJECTIVE: To test the hypothesis that cervical ripening using a combination of misoprostol and a transcervical Foley bulb leads to delivery within a shorter time compared with misoprostol alone. METHODS: This randomized controlled trial was offered to women admitted for cervical ripening. Inclusion criteria were gestational age 37 weeks or greater with intact membranes, singleton fetus, cephalic presentation, and Bishop score 6 or less. Exclusion criteria included, among others, prior uterine surgery, ruptured membranes, and any contraindication to vaginal delivery. Patients were randomized to cervical ripening using misoprostol and a transcervical Foley bulb simultaneously or misoprostol alone. Primary outcome was time from placement of the misoprostol to delivery. Secondary outcomes included time to active phase, time from active phase to delivery, cesarean delivery rate, uterine tachysystole, estimated blood loss, chorioamnionitis, cord pH, 5-minute Apgar score, and neonatal intensive care unit admission. Sample size calculation revealed that 94 participants were required in each group to detect a 3-hour difference with 80% power and α error of 0.05. Intention-to-treat analysis was performed. RESULTS: From September 2015 to July 2016, a total of 200 patients were randomized, 100 to each group. There were no differences between groups with respect to parity, body mass index, gestational age, Bishop score, birth weight, or indication for induction. Time to delivery was significantly shorter in the combined misoprostol-transcervical Foley group: 15.0 (11.0-21.8) hours (median [interquartile range]) vs 19.0 (14.0-27.3) hours in the misoprostol-only group (P=.001). This time difference remained significant after subanalysis by parity or after excluding cesarean deliveries. There was no difference between groups with respect to the rate or indication for cesarean delivery, estimated blood loss, rate of tachysystole, chorioamnionitis, or neonatal outcomes. CONCLUSION: Cervical ripening using misoprostol in combination with a transcervical Foley bulb is an effective method to shorten the course of labor compared with misoprostol alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02566005.

Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes.

OBJECTIVE: We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. STUDY DESIGN: We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed. RESULTS: In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group. CONCLUSION: IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.