United States' experience in nuchal translucency measurement: variation according to provider characteristics in over five million ultrasound examinations.

OBJECTIVE: The Nuchal Translucency Quality Review (NTQR) program has provided standardized education, credentialing and epidemiological monitoring of nuchal translucency (NT) measurements since 2005. Our aim was to review the effect on NT measurement of provider characteristics since the program's inception. METHODS: We evaluated the distribution of NT measurements performed between January 2005 and December 2019, for each of the three primary performance indicators of NT measurement (NT median multiples of the median (MoM), SD of log10 NT MoM and slope of NT with respect to crown-rump length (CRL)) for all providers within the NTQR program with more than 30 paired NT/CRL results. Provider characteristics explored as potential sources of variability included: number of NT ultrasound examinations performed annually (annual scan volume of the provider), duration of participation in the NTQR program, initial credentialing by an alternative pathway, provider type (physician vs sonographer) and number of NT-credentialed providers within the practice (size of practice). Each of these provider characteristics was evaluated for its effect on NT median MoM and geometric mean of the NT median MoM weighted for the number of ultrasound scans, and multiple regression was performed across all variables to control for potential confounders. RESULTS: Of 5 216 663 NT measurements from 9340 providers at 3319 sites, the majority (75%) of providers had an NT median MoM within the acceptable range of 0.9-1.1 and 85.5% had NT median MoM not statistically significantly outside this range. Provider characteristics associated with measurement within the expected range of performance included higher volume of NT scans performed annually, practice at a site with larger numbers of other NT-credentialed providers, longer duration of participation in the NTQR program and alternative initial credentialing pathway. CONCLUSIONS: Annual scan volume, duration of participation in the NTQR program, alternative initial credentialing pathway and number of other NT-credentialed providers within the practice are all associated with outcome metrics indicating quality of performance. It is critical that providers participate in ongoing quality assessment of NT measurement to maintain consistency and precision. Ongoing assessment programs with continuous feedback and education are necessary to maintain quality care. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Prevention of preterm birth with pessary in singletons (PoPPS): randomized controlled trial.

OBJECTIVE: To determine if pessary use prevents preterm birth (PTB) in women with singleton pregnancy, with short cervical length (CL) measured on transvaginal sonography (TVS) and without prior spontaneous PTB (sPTB). METHODS: This was an open-label multicenter randomized trial of asymptomatic women presenting at 18 + 0 to 23 + 6 weeks' gestation with a singleton pregnancy, CL ≤ 25 mm on TVS and no prior sPTB. sPTB included those with spontaneous onset of labor and those with rupture of membranes prior to labor. Subjects were randomized to receive either a Bioteque cup pessary or no pessary. Pessaries were inserted by trained maternal-fetal medicine staff. Vaginal progesterone was recommended to women with CL ≤ 20 mm. The primary outcome was PTB < 37 weeks. A sample size of 121 women in each group (n = 242) was needed to detect a reduction in the primary outcome from 30% in the no-pessary group to 15% in the pessary group. The trial was stopped early before complete enrollment. RESULTS: Between 17 March 2014 and 29 July 2016, 17 383 women underwent CL measurement on TVS. Of these, 422 (2.4%) had CL ≤ 25 mm and 391 (92.7%) met the full eligibility criteria, of which 122 (31.2%) agreed to randomization. Sixty-one (50%) women were randomized to the pessary group and 61 (50%) to the no-pessary group. Baseline characteristics were similar between the groups. There were no significant differences between the pessary and no-pessary groups in the rate of PTB < 37 weeks (43% vs 40%; relative risk 1.09; 95% CI, 0.71-1.68) or in secondary outcomes, such as rate of PTB < 34 weeks, rate of PTB < 28 weeks, gestational age at delivery, birth weight and rate of composite adverse neonatal outcome. CONCLUSIONS: Cervical pessary use was not associated with prevention of PTB in women with a singleton pregnancy, short CL on TVS and no prior sPTB in this small, underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Prevention of preterm birth with pessary in twins (PoPPT): a randomized controlled trial.

OBJECTIVE: To evaluate whether cervical pessary placement prevents preterm birth (PTB) in twin gestations with a short mid-trimester cervical length (CL) on transvaginal sonography (TVS). METHODS: This was a multicenter randomized controlled trial of asymptomatic women with a twin gestation and a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks' gestation. TVS-CL was measured at the time of the fetal anatomy scan at 18 + 0 to 23 + 6 weeks and at subsequent scheduled ultrasound scans prior to 28 weeks. Women with a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks were randomized to receive either the Bioteque™ cup cervical pessary or no pessary. Randomization was stratified by gestational age, study site and chorionicity. Women with a monoamniotic twin gestation, twin-twin transfusion syndrome, early selective intrauterine growth restriction or placenta previa were excluded. Cervical pessaries were inserted by maternal-fetal medicine staff centrally trained in proper placement. No other treatment for women with a short cervix was recommended. Primary outcome was PTB < 34 weeks. The trial was stopped early before complete enrollment. RESULTS: A total of 421 women with a twin gestation were screened for TVS-CL, and 85 (20%) had a TVS-CL of ≤ 30 mm. Of these, 80 (94%) met the eligibility criteria and 46 (58%) of the eligible women agreed to randomization. Twenty-three (50%) women were randomized to pessary placement and 23 (50%) to no pessary. Demographic characteristics, including median gestational age (21.0 vs 21.2 weeks; P = 0.69) and TVS-CL (16.7 vs 22.9 mm; P = 0.45) at randomization, were similar between the pessary and no-pessary groups, except for level of education (more than high school education: 48% vs 78%, respectively; P = 0.03) and proportion of spontaneous conceptions (83% vs 43%, respectively; P = 0.01). There were no significant differences between the pessary and no-pessary groups in rate of primary outcome, PTB < 34 weeks (39% vs 35%; relative risk, 1.13 (95% CI, 0.53-2.40)), as well as other outcomes, including PTB < 37 weeks and < 28 weeks, gestational age at delivery, birth weight and composite adverse neonatal outcome. CONCLUSION: Treatment with cervical pessary was not associated with the prevention of PTB in women with a twin gestation and a mid-trimester TVS-CL of ≤ 30 mm in this small underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Maintaining quality assurance for sonographic nuchal translucency measurement: lessons from the FASTER Trial.

OBJECTIVE: To evaluate nuchal translucency measurement quality assurance techniques in a large-scale study. METHODS: From 1999 to 2001, unselected patients with singleton gestations between 10 + 3 weeks and 13 + 6 weeks were recruited from 15 centers. Sonographic nuchal translucency measurement was performed by trained technicians. Four levels of quality assurance were employed: (1) a standardized protocol utilized by each sonographer; (2) local-image review by a second sonographer; (3) central-image scoring by a single physician; and (4) epidemiological monitoring of all accepted nuchal translucency measurements cross-sectionally and over time. RESULTS: Detailed quality assessment was available for 37 018 patients. Nuchal translucency measurement was successful in 96.3% of women. Local reviewers rejected 0.8% of images, and the single central physician reviewer rejected a further 2.9%. Multivariate analysis indicated that higher body mass index, earlier gestational age and transvaginal probe use were predictors of failure of nuchal translucency measurement and central image rejection (P = 0.001). Epidemiological monitoring identified a drift in measurements over time. CONCLUSION: Despite initial training and continuous image review, changes in nuchal translucency measurements occur over time. To maintain screening accuracy, ongoing quality assessment is needed.

First- and second-trimester Down syndrome screening markers in pregnancies achieved through assisted reproductive technologies (ART): a FASTER trial study.

OBJECTIVE: To determine whether first- and second-trimester Down syndrome screening markers and screen-positive rates are altered in pregnancies conceived using assisted reproductive technologies (ARTs). METHODS: ART pregnancies in the multicenter FASTER trial were identified. Marker levels were evaluated for five types of ART: in vitro fertilization with ovulation induction (IVF-OI), IVF with OI and egg donation (IVF-OI-ED), IVF with ED (IVF-ED), and intrauterine insemination with OI (IUI-OI) or without OI (IUI). Each group was compared to non-ART controls using Mann-Whitney U analysis. RESULTS: First-trimester marker levels were not significantly different between ART and control pregnancies, with the exception of reduced PAPP-A levels in the IUI-OI group. In contrast, second-trimester inhibin A levels were increased in all ART pregnancies, estriol was reduced and human chorionic gonadotropin (hCG) was increased in IVF and IUI pregnancies without ED, and alpha-fetoprotein (AFP) was increased in ED pregnancies. Second-trimester screen-positive rates were significantly higher than expected for ART pregnancies, except when ED was used. CONCLUSIONS: These data show that ART significantly impacts second-, but not first-, trimester markers and screen-positive rates. The type of adjustment needed in second-trimester screening depends on the particular type of ART used.

First trimester prenatal diagnosis of chondroectodermal dysplasia (Ellis-van Creveld syndrome) with ultrasound.

Chondroectodermal dysplasia (Ellis-van Creveld syndrome) is an autosomal recessive condition characterized by short-limb dwarfism, postaxial polydactyly, ectodermal defects, and congenital heart disease. This condition is most prevalent in the Amish population of Lancaster, Pennsylvania, USA, occurring in 1/5000 births and in 1/60,000 births in the general population. This report presents a case of ultrasonographic detection of chondroectodermal dysplasia at 12 weeks of gestation.

Skeletal anomalies.

It is possible to identify many types of skeletal dysplasias and conditions involving limb deformities prenatally using ultrasound. It is likely that in the future, with the advancing technology and discoveries in molecular genetics, specific mutation analysis will become available for many of these conditions. This will make first trimester diagnosis an option in many cases. Because of the complex nature of many of these cases, it may be helpful to use a multidisciplinary approach involving a radiologist and a geneticist at times. In utero radiographs may help clarify a diagnosis. In lethal cases where a specific diagnosis has not been confirmed, it may be helpful postpartum to obtain an autopsy; photographs; complete body radiographs; karyotypic analysis; and specimens of bone, cartilage, and fetal blood for further analysis.

The effect of spinal anesthesia on the success rate of external cephalic version: a randomized trial.

OBJECTIVE: To identify the effect of spinal anesthesia on the success rate of external cephalic version after 36 weeks' gestation. METHODS: Women with singleton breech presentations after 36 weeks' gestation were offered enrollment. Those who agreed were randomized to receive spinal anesthesia or no anesthesia. Up to four attempts were made using ultrasound surveillance. External cephalic version was terminated with patient discomfort or fetal heart decelerations. Statistical analysis based on intent-to-treat was performed using chi2, Student t tests, and multivariate analysis. Sample size projection based on 20% difference in success rate from a baseline of 50% indicated a need for 50 women in each group. RESULTS: One hundred two women were entered in the study from October 1993 to August 1997. There were no differences between groups in parity, maternal age, amniotic fluid index, gestational age, birth weight, placental location, type of breech presentation, maternal weight, or gestational age at delivery. Forty-four external cephalic versions were successful. Fifty (49%) women received spinal anesthesia, and 52 (51%) did not; there was no difference in the overall success rate between groups (44% spinal versus 42% no spinal). Spontaneous version occurred before external cephalic version was attempted in four patients in the spinal group (after the spinal was given) and one patient in the no-spinal group. These patients were included in the analysis. CONCLUSION: Spinal anesthesia does not increase the external cephalic version success rate in singleton pregnancies with breech presentations after 36 weeks' gestation.

Sonographic measurement of the fetal rib cage perimeter to thoracic circumference ratio: application to prenatal diagnosis of skeletal dysplasias.

The object of this study was to establish new normative data for the fetal rib cage perimeter to thoracic circumference ratio, and to evaluate the potential application of this measurement in the diagnosis of short rib and other skeletal dysplasias. Rib cage perimeter (RCP) and thoracic circumference (TC) were measured in a prospective, cross-sectional sample of 88 patients with normal pregnancies between 14 and 39 weeks of gestation. The RCP and TC were both measured in cross-section, at a level of the four-chamber view of the fetal heart. RCP and TC measurements were also obtained from eight cases known to have skeletal dysplasias. The mean (+/- SE) RCP:TC ratio in normal pregnancies, regardless of gestational age, was 0.670 +/- 0.004. In five of eight cases with skeletal dysplasias the RCP:TC ratio was significantly decreased, and in one case it was increased. The RCP:TC ratio in normal fetuses is independent of gestational age. In this small series the ratio was abnormal in fetuses with certain skeletal dysplasias, and particularly decreased in the fetus with a short rib-polydactyly syndrome. After further evaluation, this technique may prove to be of clinical significance in helping to diagnose skeletal dysplasias, particularly in cases where the gestational age is uncertain.

Neurofibromatosis type 1 and pregnancy.

Neurofibromatosis Type 1 (NF-1) is an autosomal dominant condition which has markedly variable clinical expression, with manifestations ranging from mild cutaneous lesions to severe orthopedic complications and functional impairment. The current obstetrical literature indicates that women with NF-1 have increased complications associated with pregnancy. However, the majority of publications are case reports involving no more than 11 patients each, and are likely biased toward reporting on cases in which complications occurred. This study presents data on pregnancy outcome in 105 women with NF-1. The data were obtained from questionnaires completed by the study participants, and by review of their pregnancy and peripartum medical records. The 105 women had a total of 247 pregnancies, resulting in 182 live births, 44 first trimester spontaneous abortions, 21 elective terminations, and 2 ectopic pregnancies. There were two sets of twins. The cesarean section rate in our series (36%) was greater than the general population rate (9.1-23.5%). In 7 of these patients, the cesarean section was required because of maternal NF-1 complications. The study did not show the previously reported increased incidence of preeclampsia, preterm delivery, intrauterine growth restriction, pregnancy-induced hypertension, stillbirth, spontaneous abortion, or perinatal mortality. Sixty-four (60%) of the one hundred five women reported growth of new neurofibromas during pregnancy and fifty-five (52%) noted enlargement of existing neurofibromas. Nineteen women observed no changes in the size of their neurofibromas and no growth of new neurofibromas during pregnancy.

Assessing the acceptability of Norplant contraceptive in four patient populations.

The object of this study was to review the experience of Norplant implants insertion at the University of Colorado Health Sciences Center with specific attention to the potential impact of source of care and/or clinic site of of insertion. Norplant implants were inserted at four different office sites, namely, adolescent-teen, resident, certified nurse midwife, and faculty physician. The charts of all patients who had Norplant implants inserted between April 1991 and September 1992 were reviewed and we attempted to contact each patient by telephone to assess clinical course and acceptability of Norplant contraceptive. We were able to contact 254 of 414 women (61%) who had Norplant implants inserted. The average length of time since Norplant implants insertion was 13.2 months. The only significant demographic difference between groups was that the adolescent-teen patients were younger, of lower parity, less educated, and were more likely to be single than the other three groups. The overall removal proportion was 14.6%, and removal proportions were not significantly different between any of the four groups. The primary reason for removal was unacceptable bleeding (32% of removers). Only 59% of patients returned for follow-up care. Faculty physician patients were significantly more compliant with follow-up compared to adolescent-teen and resident patients (p < 0.01). Patient retention of Norplant contraceptive is unrelated to age or the clinic setting in which the device was inserted. Since similar side effects are experienced by retainers and removers, it is unclear what other factors prompt women to seek removal. Particularly in the teen and resident groups, follow-up is poor.

PIP: To refine understanding of the acceptability of Norplant in the US on the basis of different target populations and sources of care, the experiences of four groups of clients who had the implants inserted at University of Colorado Health Sciences Center between April 1991 and September 1992 and could be reached for a postinsertion telephone interview were compared. The 254 women interviewed (61% of total acceptors over this period) were drawn from four clinics: adolescent, resident, certified nurse midwife, and faculty physician. The average length of time since insertion was 13.2 months. As expected, adolescent patients were significantly more likely to be younger, single, less educated, and of lower parity than women in the three other groups. The overall removal rate was 14.6%, with no significant difference among groups or in terms of factors such as age, race, or socioeconomic status; the mean time to removal was 10.2 months. The most common reason for removal (32%) was unacceptable bleeding; however, abnormal bleeding was not significantly associated with the decision to discontinue the method. Weight gain and headache were the only side effects reported significantly more frequently by removers than retainers. Only 150 (59%) women returned for a scheduled postinsertion follow-up visit; compliance was lowest among teens (41%) and highest among patients of faculty (77%). 10 of the 37 women who opted for removal had this procedure performed at another clinic site; this finding suggests that clinic-based studies may underestimate the actual Norplant discontinuation rate.

Megestrol acetate for treatment of endometriosis.

Between 1977-1989, 29 women with symptomatic endometriosis were treated with megestrol acetate by the Johns Hopkins Division of Reproductive Endocrinology. All had previously received one or more alternative medical treatments for endometriosis, in each case discontinued because of poor response or development of unacceptable side effects. Treatment consisted of a daily dose of 40 mg megestrol acetate orally for up to 24 months. Disease-related symptoms (dysmenorrhea, noncyclic pelvic pain, and dyspareunia) were relieved in 86% of the subjects treated with an adequate course of therapy. Side effects were fairly well tolerated, although eight women discontinued treatment within 2 months and two others stopped the drug by 4 months. These preliminary findings suggest that megestrol acetate may be an effective treatment for patients with endometriosis, even those who have been unresponsive to other modes of therapy.