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Cell-free DNA fetal fraction in twin gestations in single-nucleotide polymorphism-based noninvasive prenatal screening

Hedriana, Herman; Martin, Kimberly; Saltzman, Daniel; Billings, Paul; Demko, Zachary; Benn, Peter
OBJECTIVES:The performance of noninvasive prenatal screening (NIPS) for fetal aneuploidy in twin pregnancies is dependent on the amount of placentally derived cell-free DNA, the "fetal fraction (FF)," present in maternal plasma. We report FF values in monozygotic (MZ) and dizygotic (DZ) pregnancies. METHODS:We reviewed FF in pregnancies at 10 to 20 completed weeks gestational age based on single-nucleotide polymorphism (SNP)-based NIPS where zygosity was routinely established in twin pregnancies. The cohort included 121 446 (96.3%) singleton, 1454 (1.2%) MZ, and 3161 (2.5%) DZ pregnancies. For DZ twins, individual FFs were measured. RESULTS:Combined FF for DZ and MZ fetuses were 35% and 26% greater than singletons, respectively. The individual FF contributions from each fetus in DZ twins were, on average, 32% less than singletons. FF in DZ twin pairs were moderately correlated (Pearson correlation coefficient.66). When a threshold of 2.8% FF was applied to define uninterpretable results, 1.7% (2102/121 446) of singletons, 0.8% (11/1454) of MZ pairs, and 5.6% (178/3161) of DZ pairs were uninterpretable. CONCLUSION:For optimal aneuploidy NIPS in twin pregnancies, zygosity should be established and in DZ twins FF for both fetuses should be determined to identify those cases where results can be reliably interpreted.
PMCID:7027570
PMID: 31711265
ISSN: 1097-0223
CID: 4481342

Change in cervical length and spontaneous preterm birth in nulliparous women with a history of loop electrosurgical excision procedure

Gupta, Simi; Chen, Stefanie; Naqvi, Mariam; Saltzman, Daniel H; Rebarber, Andrei; Monteagudo, Ana; Fox, Nathan S
Background: Prior studies have shown an association between history of loop electrode procedures (LEEP) and spontaneous preterm delivery (SPTD) independent of midtrimester cervical length. These studies suggest that there may be other factors beyond an individual cervical length, which contributes to identifying at risk pregnancies. Objective: The objective of this study is to determine the association between change in cervical length and SPTD in women with a history of LEEP. Study design: This is a retrospective cohort study of singleton nulliparous women with a history of LEEP who received serial cervical length measurements at a single institution between 2012 and 2016. Women with serial cervical lengths and available outcome data were included. The cervical length at different gestational ages and rate of change in length was compared with the risk for SPTD < 37 weeks using Student's t-test. Results: One hundred thirty subjects met inclusion criteria for the study. The mean cervical length (35.3 versus 39.8 mm, p = 0.042 at 16 weeks; 32.2 versus 37.8 mm, p < 0.01 at 20 weeks; 29.9 versus 35.6 mm, p = 0.027 at 24 weeks; 21.6 versus 33.4 mm, p < 0.01 at 28 weeks) was significantly different between women who had a SPTD < 37 weeks compared to women who did not. The average rate of change in transvaginal cervical length between 16 to 28 weeks was significantly different between women who had a SPTD < 37 weeks compared to women who did not (-1.4 versus 0.4 mm/wk, p < 0.01). Conclusion: Women with a history of LEEP who had a SPTD < 37 weeks had a shorter cervical length at 16, 20, 24, and 28 weeks' gestation and a higher rate of change in cervical length between 16 and 28 weeks than women without a history of SPTD. Our findings support the concept of the preterm birth syndrome as an evolving biophysical process rather than a distinct event, suggesting improved prediction in the setting of prior history of a LEEP with serial imaging.
PMID: 31416405
ISSN: 1476-4954
CID: 4042702

Fetal fraction-based risk algorithm for non-invasive prenatal testing: screening for trisomy 13, 18, and triploidy in women with low cell-free fetal DNA

McKanna, Trudy; Ryan, Allison; Krinshpun, Shifra; Kareht, Stephanie; Marchand, Karen; Grabarits, Caitlin; Ali, Marwan; McElheny, Ashley; Gardiner, Kate; LeChien, Kay; Hsu, Melissa; Saltzman, Daniel; Stosic, Melissa; Martin, Kimberly; Benn, Peter
OBJECTIVE:To identify pregnancies at increased risk for trisomy 13, trisomy 18, and triploidy attributable to low fetal fraction (FF). METHODS:A FF-based risk (FFBR) model was built using data from >165,000 singleton pregnancies referred for SNP-based non-invasive prenatal testing (NIPT). Based on maternal weight and gestational age, FF distributions for normal, trisomy 13, trisomy 18, and triploid pregnancies were constructed and used to adjust prior risks for these abnormalities. A risk cutoff of ≥1% was chosen to define pregnancies at high risk for trisomy 13, trisomy 18, or triploidy (i.e., a high FFBR score). The model was evaluated on an independent blinded set of pregnancies for which SNP-based NIPT did not return a result, and for which retrospectively gathered pregnancy outcome information was available. RESULTS:The evaluation cohort comprised 1,148 cases, of which approximately half received a high FFBR score. Compared with incidence rates expected based on maternal age (MA) and gestational age (GA), cases with a high FFBR score had a significantly increased rate of trisomy 13, trisomy 18, or triploidy combined (5.7% vs. 0.7%; p<0.001) and of unexplained pregnancy loss (14.7% vs 10.4% p<0.001). For cases that did not receive a high FFBR score, the incidence of a chromosome abnormality or loss was not significantly different than that expected based on MA and GA. In the study cohort, the sensitivity of the FFBR model for detection of trisomy 13, trisomy 18, or triploidy was 91.4% (95% CI: 76.9-98.2) with a positive predictive value of 5.7% (32/564; 95% CI: 3.9-7.9). CONCLUSIONS:For pregnancies with a FF too low to receive a result on standard NIPT, the FFBR algorithm can identify a subset of cases at increased risk for trisomy 13, trisomy 18, or triploidy. For the remainder of cases, the risk for a fetal chromosome abnormality was unchanged.
PMID: 30014528
ISSN: 1469-0705
CID: 3206482

Long-term outcomes of twins based on gestational age at delivery

Stern, Erica; Cohen, Natalie; Odom, Elizabeth; Stroustrup, Annemarie; Gupta, Simi; Saltzman, Daniel H; Rebarber, Andrei; Fox, Nathan S
OBJECTIVE:Prematurity is associated with adverse outcomes. However, there are less data regarding long-term outcomes of twins based on gestational age at delivery. Our objective was to identify the association between gestational age at delivery and long-term outcomes in twins. STUDY DESIGN/METHODS:All patients with a twin pregnancy ≥24 weeks delivered by a single Maternal Fetal Medicine practice from 2005 to 2014 were surveyed regarding pediatric outcomes at or after 2 years of life. We excluded twins with aneuploidy or major fetal anomalies. The survey was mail-based, with phone follow-up for nonresponses or for clarification. Using logistic regression analysis, we compared long-term outcomes between twins born in four gestational age groups: 24 to 27-6/7 weeks, 28 to 31-6/7 weeks, 32 to 35-6/7 weeks, and 36 weeks or later. RESULTS:Six hundred fifty-three twin deliveries met inclusion criteria and 425 (65.1%) mothers responded. Mean age at the time of survey completion was 6.0 ± 2.4 years. Earlier gestational age was significantly associated with neonatal death (14, 2, 0, and 0% in the four groups, respectively, p < .001). Prematurity was associated with a composite of major adverse outcomes (death; cerebral palsy; necrotizing enterocolitis; chronic renal, heart, or lung disease) (14, 7, 4, and 2% in the four groups, p = .036), as well as minor adverse outcomes (learning disability; need for speech, occupational, or physical therapy) (83, 69, 54, and 38%, p < .001). CONCLUSIONS:Long-term morbidity in twin pregnancies is inversely related to gestational age at delivery. However, for twins born after 28 weeks, neonatal death and severe long-term morbidity are rare.
PMID: 28783997
ISSN: 1476-4954
CID: 3072652

The association between fetal fibronectin and spontaneous preterm birth in twin pregnancies with a shortened cervical length

Matthews, Kathy C; Gupta, Simi; Lam-Rachlin, Jennifer; Saltzman, Daniel H; Rebarber, Andrei; Fox, Nathan S
OBJECTIVE:To estimate the association between a positive fetal fibronectin (fFN) and spontaneous preterm birth (SPTB) in twin pregnancies with a shortened cervical length (CL). STUDY DESIGN/METHODS:Retrospective cohort study of asymptomatic twin pregnancies managed by a single MFM practice from 2005 to 2016. We included all women with a shortened CL ≤25 mm at 22-28 weeks, and compared outcomes between women with a positive and negative fFN result. RESULTS:One hundred fifty-five patients were included, 129 (83.2%) of whom had a negative fFN and 26 (16.8%) of whom had a positive fFN. Baseline characteristics were similar between groups, except for the CL at the time of diagnosis of short cervix (15 mm in the positive fFN group versus 20 mm in the negative fFN group, p = .002). The risk of SPTB <32 weeks was significantly higher in the positive fFN group (46.2 versus 12.6%, aOR 3.54, 95% CI 1.26, 9.92) and the mean gestational age at delivery was significantly earlier (31.1 versus 35.2 weeks, p < .001). CONCLUSIONS:In asymptomatic women with twin pregnancies and a shortened CL, a positive fFN is significantly associated with SPTB and can modify the risk substantially. If performing a screening CL assessment in a twin pregnancy, fFN testing should be done concurrently.
PMID: 28651447
ISSN: 1476-4954
CID: 3074022

Double versus single thrombophilias during pregnancy

Carroll, Rachel; Rebarber, Andrei; Booker, Whitney; Fox, Nathan; Saltzman, Daniel; Lam-Rachlin, Jennifer; Gupta, Simi
OBJECTIVE:The primary objective of this study was to evaluate whether women with double thrombophilias have a greater risk for obstetric complications as compared with women who have single thrombophilias. STUDY DESIGN/METHODS:This is a retrospective cohort study of all patients in a single practice with a clinically significant inherited thrombophilia and treated with anticoagulation between 2005 and 2013. Thrombophilias evaluated include: factor V Leiden, prothrombin G20210A gene mutation, protein S deficiency, protein C deficiency, and antithrombin III deficiency. Double thrombophilia was defined as the presence of two thrombophilias or homozygosity for factor V Leiden or prothrombin Gene Mutation. Demographic and obstetrical outcome data were collected. Data on all patients with double thrombophilias who met inclusion criteria was reported. Data was then compared between the patients with double thrombophilias and single thrombophilias with singleton gestations. The data was analyzed with Pearson's chi-squared or Student's t-test as appropriate with p value <.05 used for significance. RESULTS:Eighteen patients with clinically significant double thrombophilias who met inclusion criteria were identified. Most patients delivered full term (88.9%) and appropriate for gestational age (77.8%) infants. One hundred thirty-two patients with single thrombophilias and 14 patients with double thrombophilias with singleton gestations were then compared. Demographic characteristics were not significantly different between the two groups. There were no significant differences in obstetrical outcomes between patients. CONCLUSIONS:There were no significant differences in obstetrical outcomes for patients with clinically significant double thrombophilias versus single thrombophilias when treated with anticoagulation.
PMID: 28670948
ISSN: 1476-4954
CID: 3074412

Antenatal Testing for Women With Preexisting Medical Conditions Using Only the Ultrasonographic Portion of the Biophysical Profile

Zafman, Kelly B; Bruck, Efrat; Rebarber, Andrei; Saltzman, Daniel H; Fox, Nathan S
OBJECTIVE:To report the utility of the ultrasonographic biophysical profile, which includes all the components of a biophysical profile minus the nonstress test, in women with maternal indications for antepartum surveillance. METHODS:We conducted a case series reviewing the records of all women at 32 weeks of gestation or greater with at least one indication for antenatal testing (per the American College of Obstetricians and Gynecologists) delivered by a single maternal-fetal medicine practice between 2006 and 2018. Indications included diabetes, hypertension, lupus, antiphospholipid syndrome, sickle cell disease, renal disease, heart disease, hyperthyroidism, isoimmunization, inherited thrombophilia, and prior intrauterine fetal demise. Weekly ultrasonographic biophysical profiles were initiated at 32 weeks of gestation. We calculated the test-positive rate, the percentage of women delivered for an abnormal ultrasonography biophysical profile, and the intrauterine fetal demise rate (false-negative rate). RESULTS:Nine hundred eighty-five women underwent 3,981 ultrasonographic biophysical profiles (four per woman; range 1-11). Sixteen women had an abnormal ultrasonographic biophysical profile, for a test positive rate of 1.6% (95% CI 1.0-2.6%) per woman, or 0.4% (95% CI 0.3-0.7%) per ultrasonographic biophysical profile. Of the 16 women with abnormal ultrasonographic biophysical profiles, 13 were delivered with good outcomes and three women had normal follow-up testing and uncomplicated deliveries at a later date. There were three women with intrauterine fetal demise (false-negative rate of 0.3%, 95% CI 0.1-0.9%). One woman with intrauterine fetal demise had a factor V Leiden mutation, fetal ventriculomegaly, and fetal growth restriction. The second woman with intrauterine fetal demise had advanced maternal age, a factor V Leiden mutation, and fetal growth restriction. The third woman with intrauterine fetal demise had class B diabetes. All three intrauterine fetal demises were diagnosed antepartum with an interval from normal ultrasonographic biophysical profile to intrauterine fetal demise of 7, 7, and 6 days, respectively. CONCLUSION/CONCLUSIONS:The use of ultrasonographic biophysical profile in a high-risk cohort is associated with a very low test-positive rate and a very low incidence of intrauterine fetal demise. In women with preexisting medical conditions that place them at higher risk for intrauterine fetal demise, ultrasonographic biophysical profile can be used for antenatal testing.
PMID: 30130352
ISSN: 1873-233x
CID: 3255102

Long-term outcomes of twins based on the intended mode of delivery

Fox, Nathan S; Cohen, Natalie; Odom, Elizabeth; Gupta, Simi; Lam-Rachlin, Jennifer; Saltzman, Daniel H; Rebarber, Andrei
OBJECTIVE:Recent studies have shown that for twin pregnancies with a cephalic presenting first twin, planned vaginal delivery is not associated with adverse short-term neonatal outcomes, as compared to planned cesarean delivery. Our objective was to compare long-term outcomes in twins, based on planned mode of delivery. STUDY DESIGN/METHODS:This was a prospective, observational cohort of twin pregnancies delivered by a single MFM practice. All the patients with a twin pregnancy >34 weeks delivered from 2005-2014 were surveyed regarding pediatric outcomes at or after 2 years of life. The survey was mail-based, with phone follow-up for nonresponses or for clarification of answers. Using chi-square, Student's t-tests, and regression analysis we compared outcomes between women who planned a vaginal (with active management of the second stage) versus cesarean delivery. The main outcome measures were: (1) a composite of major adverse outcomes (death, cerebral palsy, necrotizing enterocolitis, chronic renal, heart, or lung disease); (2) a composite of minor adverse outcomes (learning disability, speech therapy, occupational therapy, physical therapy). RESULTS:Five hundred and thirty-two women met inclusion criteria and 354 (66.5%) responded. 178 (50.3%) women planned to have a cesarean delivery (100% of whom had a cesarean delivery) and 176 (49.7%) women planned to have a vaginal delivery (83% of whom had a vaginal delivery). The average age of the children at the time of the survey was 5.9 years. There were no differences in any pediatric outcomes between the two groups. After controlling for maternal age, IVF, obesity, and preeclampsia, the planned mode of delivery was not associated with a composite of major adverse outcomes (aOR 0.673, 95% CI 0.228, 1.985), nor a composite of minor adverse outcomes (aOR 0.767, 95% CI 0.496, 1.188). CONCLUSIONS:Planned vaginal delivery with active management of the second stage of labor in twin pregnancies >34 weeks is not associated with adverse childhood outcomes.
PMID: 28573880
ISSN: 1476-4954
CID: 3076512

Outcomes in patients with early-onset fetal growth restriction without fetal or genetic anomalies

Gupta, Simi; Naert, Mackenzie; Lam-Rachlin, Jennifer; Monteagudo, Ana; Rebarber, Andrei; Saltzman, Daniel; Fox, Nathan S
OBJECTIVE:Early-onset fetal growth restriction is associated with poor pregnancy outcomes, but frequently is due to fetal structural or chromosomal abnormalities. The objective of this study was to determine outcomes in patients with early-onset fetal growth restriction without diagnosed fetal or genetic anomalies and to identify additional risk factors for poor outcomes in these patients. METHODS:This was retrospective cohort study of singleton pregnancies in women with early-onset growth restriction defined as a sonographic estimated fetal weight <10% diagnosed between 16-28 weeks' gestation. We excluded all women with a fetal structural or chromosomal abnormality diagnosed prenatally. Data on pregnancy characteristics and outcomes were collected and analyzed for estimated fetal weight <10% and ≤5%. A nested case-control study within the cohort of patients with ongoing pregnancies was then performed to identify risk factors associated with poor pregnancy outcome using chi-squared test. RESULTS:One hundred forty-two patients were identified who met inclusion and exclusion criteria and 20 patients were found to have fetal structural or chromosomal abnormalities. In the remaining 122 patients, the incidence of intrauterine fetal demise was 5.7% and there were high rates of preterm birth <37 weeks (20%), birth weight <10% (59.3%), and gestational hypertension (14.1%). Later gestational age at diagnosis and the presence of echogenic bowel and abnormal initial umbilical artery Dopplers were associated with poor pregnancy outcome (22.56 versus 20.86 weeks, p = .046), (17.4 versus 2.2%, OR 9.68, 95%CI 1.65-56.73), and (35.3 versus 0%, OR 4.46, 95%CI 2.65-7.50) respectively. CONCLUSIONS:Patients with early-onset fetal growth restriction with no fetal structural or genetic abnormality have a high risk of poor pregnancy outcomes. Gestational age at diagnosis and certain ultrasound findings are associated with poor pregnancy outcome.
PMID: 29478342
ISSN: 1476-4954
CID: 2991282

Suture Compared With Staple Closure of Skin Incision for High-Order Cesarean Deliveries

Fox, Nathan S; Melka, Stephanie; Miller, James; Bender, Samuel; Silverstein, Michael; Saltzman, Daniel H; Rebarber, Andrei
OBJECTIVE:To compare wound complication rates in tertiary or higher-order cesarean delivery based on wound closure technique. METHODS:We performed a retrospective cohort study of all tertiary or higher-order cesarean deliveries performed by one group practice in a large academic medical center from 2005 to 2017. We excluded patients with a vertical skin incision. Although the study was not randomized, wound closure type was relatively uniform in this practice and based on time period: before 2011, the preferred closure was staple closure; after 2011, subcuticular suture closure was preferred. All patients received preoperative antibiotics and closure of subcutaneous tissue 2 cm deep or greater. The primary outcome was a wound complication, defined as a wound infection requiring antibiotics or a wound separation requiring wound packing or reclosure any time up to 6 weeks after delivery. Regression analysis was used to control for any significant differences at baseline between the groups. RESULTS:There were 551 patients with tertiary or higher-order cesarean delivery, 192 (34.8%) of whom had staple closure and 359 (65.2%) of whom had suture closure. Suture closure was associated with a significantly lower rate of wound complication (4.7% [17/359, 95% CI 3.0%-7.5%] vs 11.5% [22/192, 95% CI 7.7%-16.7%], P=.003). On regression analysis controlling for the number of prior cesarean deliveries and the participation of a resident in the closure, suture closure remained independently associated with a lower risk of a wound complication (adjusted odds ratio 0.44, 95% CI 0.23-0.86). CONCLUSION/CONCLUSIONS:For women undergoing their third or higher-order cesarean delivery, suture closure is associated with a lower rate of wound complications.
PMID: 29420412
ISSN: 1873-233x
CID: 2989892