Cerclage for the prevention of preterm birth in high risk women receiving intramuscular 17-α-hydroxyprogesterone caproate.

OBJECTIVE: To assess cerclage benefit in women with short cervix also receiving 17-α-hydroxyprogesterone caproate (17P) to prevent recurrent preterm birth (PTB). METHODS: Secondary analysis of a multicenter trial of ultrasound-indicated cerclage for shortened cervical length (CL). Women with prior spontaneous PTB at 16-33 6/7 weeks, singleton gestation and CL < 25 mm between 16 and 22 6/7 weeks were counseled on use of 17P and randomized to cerclage or no cerclage. Outcomes of women who received 17P were analyzed by randomization group. Primary outcome was PTB < 35 weeks. RESULTS: 99 women received 17P: 47 cerclage; 52 no cerclage. Rates of PTB < 35 weeks were similar, 30% for cerclage and 38% for no cerclage (aOR 0.64 (0.27-1.52)). In women with CL < 15 mm, PTB < 35 weeks was reduced for the cerclage group (17% vs. 75%, p = 0.02). However, this difference was nullified after controlling for total progesterone doses received (p = 0.40). CONCLUSIONS: Cerclage was shown not to offer additional benefit for the prevention of recurrent PTB in women with short CL < 25 mm receiving 17P, but the sample size is insufficient for a definite conclusion given the 36% nonsignificant decrease in the odds of PTB < 35 weeks. Cerclage may further offer substantial benefit to women with very short CL < 15 mm and further study is needed.

Suture type and ultrasound-indicated cerclage efficacy.

OBJECTIVE: To assess whether type of suture material affects cerclage efficacy for preterm birth (PTB) prevention. METHODS: Secondary analysis of a multicenter trial of ultrasound-indicated cerclage for short cervical length (CL), in which women with prior spontaneous PTB at 16-33 6/7 weeks, a singleton gestation and CL < 25 mm between 16-22 6/7 weeks, were randomized to McDonald cerclage or no cerclage. Outcomes of women who underwent cerclage were analyzed by type of suture material, comparing polyester braided thread (Mersilene™ or Ethibond™) to Mersilene tape™. Primary outcome was PTB < 35 weeks. RESULTS: 138 women underwent McDonald cerclage: 84 (61%) received polyester braided thread and 46 (33%) Mersilene tape™. Eight (6%) received monofilament suture and were excluded from analysis. Rates of PTB < 35 weeks were similar, 35% for polyester braided thread vs 24% for Mersilene tape™ (p = .24). Birth gestational age was also similar among the 2 groups (p = .18). CONCLUSION: Type of suture material may not affect ultrasound-indicated cerclage efficacy in high-risk women with short CL, but further study is needed. Polyester braided thread (Mersilene™ or Ethibond™) and polyester braided Mersilene tape™ seem to have similar efficacy.

Cervical funneling: effect on gestational length and ultrasound-indicated cerclage in high-risk women.

OBJECTIVE: The purpose of this study was to assess funnel type and pregnancy duration in women with previous spontaneous preterm birth and cervical length <25 mm. STUDY DESIGN: We performed a secondary analysis of a multicenter randomized trial of cerclage. At the randomization scan that documented short cervix, the presence and type of funnel (U or V) were recorded. RESULTS: One hundred forty-seven of 301 women (49%) had funneling: V-shaped funnel, 99 women; U-shaped funnel, 48 women. U-shaped funnel was associated significantly with preterm birth at <24, <28, <35, and <37 weeks of gestation. In multivariable models that controlled for randomization cervical length and cerclage, women with U-shaped funnel delivered earlier than women with either V-shaped funnel or no funnel. Interaction between cerclage and U-shaped funnel was observed, and analyses that were stratified by cerclage showed that women with a U-shaped funnel and cerclage delivered at a mean of 33.8 +/- 6.6 weeks of gestation, compared with women who did not receive cerclage (28.9 +/- 6.9 weeks of gestation). CONCLUSION: U-shaped funnels in high-risk women with a short cervix are associated with earlier birth.

Does midtrimester cervical length ≥25 mm predict preterm birth in high-risk women?

OBJECTIVE: We sought to assess pregnancy outcome along a continuum of cervical lengths (CLs) ≥25 mm. STUDY DESIGN: We conducted planned secondary analysis of a randomized cerclage trial of women with prior spontaneous preterm birth 17(0)-34(6/7) weeks. Outcomes of women who maintained CLs ≥25 mm were analyzed. Women with CLs <25 mm randomized to no cerclage comprised an internal comparison group. RESULTS: Of 1014 screened, 153 had CL <25 mm, and 672 had CL ≥25 mm. Birth <35 weeks occurred in 16% of the ≥25 mm cohort. The relationship between CLs ≥25 mm and birth gestational age was null (P = .15). In the <25 mm group, progressively shorter CLs predicted birth <35 weeks (P < .001); this relationship was null in the ≥25 mm group (P = .17). CONCLUSION: The continuum of CLs ≥25 mm measured between 16(0/7)-22(6/7) weeks does not predict gestational length in women with prior spontaneous preterm birth.

Gestational age at previous preterm birth does not affect cerclage efficacy.

OBJECTIVE: The purpose of this study was to evaluate the effect of earliest previous spontaneous preterm birth (SPTB) gestational age on cervical length, pregnancy duration, and ultrasound-indicated cerclage efficacy in a subsequent gestation. STUDY DESIGN: Planned secondary analysis of the National Institute of Child Health and Human Development-trial of cerclage for cervical length of <25 mm. Women with at least 1 previous SPTB between 17-33 weeks 6 days of gestation underwent serial vaginal ultrasound screening between 16 and 23 weeks 6 days of gestation; cervical length at qualifying randomization evaluation was used. RESULTS: We observed a significant correlation (P = .0008) between previous SPTB gestational age and qualifying cervical length. In a linear regression model that was controlled for cervical length and cerclage, neither previous SPTB gestational age nor the interaction between cerclage and previous birth gestational age was significant predictor of subsequent birth gestational age. CONCLUSION: Although there is an association between previous SPTB gestational age and cervical length in women with a mid-trimester cervical length of <25 mm, there does not appear to be a disproportionate benefit of cerclage in women with earlier previous SPTB.

17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length.

OBJECTIVE: We sought to evaluate 17-alpha-hydroxyprogesterone caproate (17P) for prevention of preterm birth (PTB) in women with prior spontaneous PTB (SPTB) and cervical length (CL) <25 mm. STUDY DESIGN: We conducted planned secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-sponsored randomized trial evaluating cerclage for women with singleton gestations, prior SPTB (17-33 6/7 weeks), and CL <25 mm between 16-22 6/7 weeks. Women were stratified at randomization to intent to use or not use 17P. The effect of 17P was analyzed separately for cerclage and no-cerclage groups. Primary outcome was PTB <35 weeks. RESULTS: In 300 women, 17P had no effect on PTB <35 weeks in either cerclage (P = .64) or no-cerclage (P = .51) groups. Only PTB <24 weeks (odds ratio, 0.08) and perinatal death (odds ratio, 0.14) were significantly lower for those with 17P in the no-cerclage group. CONCLUSION: 17P had no additional benefit for prevention of PTB in women who had prior SPTB and got ultrasound-indicated cerclage for CL <25 mm. In women who did not get cerclage, 17P reduced previable birth and perinatal mortality.

Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length.

OBJECTIVE: The objective of the study was to assess cerclage to prevent recurrent preterm birth in women with short cervix. STUDY DESIGN: Women with prior spontaneous preterm birth less than 34 weeks were screened for short cervix and randomly assigned to cerclage if cervical length was less than 25 mm. RESULTS: Of 1014 women screened, 302 were randomized; 42% of women not assigned and 32% of those assigned to cerclage delivered less than 35 weeks (P = .09). In planned analyses, birth less than 24 weeks (P = .03) and perinatal mortality (P = .046) were less frequent in the cerclage group. There was a significant interaction between cervical length and cerclage. Birth less than 35 weeks (P = .006) was reduced in the less than 15 mm stratum with a null effect in the 15-24 mm stratum. CONCLUSION: In women with a prior spontaneous preterm birth less than 34 weeks and cervical length less than 25 mm, cerclage reduced previable birth and perinatal mortality but did not prevent birth less than 35 weeks, unless cervical length was less than 15 mm.

Aplastic anaemia in pregnancy with severe thrombocytopenia refractory to platelet transfusion: a case and management plan.

Aplastic anaemia is a rare haematological disorder during pregnancy, which when complicated by severe thrombocytopenia poses a significant maternal risk. A woman with aplastic anaemia and a platelet (PLT) count of 11 × 10(9)/L refractory to PLT transfusion required caesarean delivery. Proactive planning by a multidisciplinary team, large volume PLT transfusion prior to surgery and postoperative uterine artery embolization resulted in avoidance of mortality. Maternal preferences should be discussed in detail due to the high risk of maternal morbidity and mortality associated with severe aplastic anaemia. This report outlines a management plan to address the medical and ethical issues faced when caring for a pregnant patient with severe aplastic anaemia and severe thrombocytopenia. We credit the good outcome to our proactive multidisciplinary approach.

Prenatal detection of fetal trisomy 18 through abnormal sonographic features.

OBJECTIVE: To describe the prenatal detection of fetal trisomy 18 through abnormal sonographic features and to determine the sensitivity of sonographically detecting fetuses with trisomy 18. METHODS: All genetic and cytogenetic records of fetuses with trisomy 18 were reviewed retrospectively (1992-2002). From these, singleton fetuses who had prenatal sonography at our unit were identified. The maximal numbers of individual abnormalities from 1 sonographic examination (not limited to type of organ system) were recorded. Each abnormality was classified as major, minor, or "other," and each organ system was classified as abnormal only once, regardless of the number of individual abnormalities identified in that system. The sensitivity of sonography in detecting abnormalities of trisomy 18 was determined. RESULTS: Of 38 fetuses identified with trisomy 18, all had 4 or more prenatally detected sonographic abnormalities (sensitivity of sonographic detection of fetuses with trisomy 18, 100%). The median number of abnormalities per examination was 8 (range, 4-19). Sonographically detected major abnormalities were cardiac (84%; n = 32), central nervous system (87%; n = 33), gastrointestinal (26%; n = 10), and genitourinary (16%; n = 6). Sonographically detected minor abnormalities were short ear length below the 10th percentile for gestational age (96%; n = 26/27), upper extremities and hands (95%; n = 36), lower extremities and feet (63%; n = 24), and face (53%; n = 20). Fifty percent (19 of 38) had choroid plexus cysts identified, but this was never an isolated finding. CONCLUSIONS: In experienced hands, the sensitivity of detecting fetal trisomy 18 on prenatal sonography is 100%, and all cases will have multiple anomalies visualized.

Prenatal detection of fetal aneuploidy by sonographic ear length.

OBJECTIVE: To determine the usefulness of a fetal ear length nomogram in the prenatal detection of fetal aneuploidy and to determine whether ear smallness in cases of aneuploidy is a primary or secondary event. METHODS: Ear lengths of 447 singleton fetuses (October 1996 to October 1997)were prospectively evaluated between 14 and 41 weeks to establish a nomogram created by modeling the mean and SD separately. Records of aneuploid fetuses were retrospectively reviewed, and their ear lengths were plotted against the nomogram to determine detection rates, with ear length in or below the 10th and 50th percentiles for a given gestational age and biparietal diameter used as abnormal cutoffs. RESULTS: The nomogram for fetal ear length measurements provided sufficient data to derive the 10th, 50th, and 90th percentiles on the basis of gestational age and biparietal diameter. The ear length of euploid fetuses was significantly correlated with gestational age (R2 = 0.96; P < .001) and biparietal diameter (R2 = 0.95; P < .001). From 96 aneuploid fetuses identified, 63 had ear lengths in or below the 10th percentile for gestational age (sensitivity, 66%). When using ear length against biparietal diameter, the sensitivities for all aneuploid fetuses for cutoffs at or below the 10th and 50th percentiles were 43% (40 of 93) and 83% (77 of 93), respectively. CONCLUSIONS: Most aneuploid fetuses have sonographically small ears (< or = 10th percentile for gestational age). This smallness is not entirely related to overall small fetal size, but in almost half the cases, the fetal ear length is disproportionately smaller than the biparietal diameter.

Down syndrome risk estimation after normal genetic sonography.

OBJECTIVE: The objective of this study was to determine whether there are any indication-specific variations in risk reduction for fetal Down syndrome after a normal genetic sonogram. STUDY DESIGN: A second-trimester genetic sonogram was offered to all pregnant women who were at increased risk for fetal Down syndrome (>/=1:274) because of either advanced maternal age (>/=35 years), an abnormal triple screen, or both. Outcome information included the results of genetic amniocentesis (if performed), the results of pediatric assessment, and follow-up after birth. Normal genetic sonography was defined as the absence of all ultrasound aneuploidy markers. RESULTS: The overall prevalence of fetal Down syndrome in the tested population was 1.41% (53/3,753 pregnancies); however, in the presence of normal genetic sonography, the overall prevalence of fetal Down syndrome was 0.21% (7/3,291 pregnancies). The overall risk reduction for fetal Down syndrome in the presence of normal genetic sonography was 6.64-fold (95% CI, 3.01-14.62); the overall negative likelihood ratio was 0.15 (95% CI, 0.07-0.33). In the presence of normal genetic sonography, the risk for fetal Down syndrome was reduced by 83% in patients with advanced maternal age, 88% in patients with abnormal triple screen, 89% in patients with abnormal triple screen who were <35 years old, and 84% in patients who had both abnormal triple screen and advanced maternal age. CONCLUSION: There were no significant variations in the risk reduction for fetal Down syndrome in the presence of normal genetic sonography. Regardless of the indication for testing, the likelihood for fetal Down syndrome was reduced by 83% to 89%. This information will be useful in counseling pregnant women who are at high risk for fetal Down syndrome and who prefer to undergo genetic sonography before deciding about genetic amniocentesis.

Second-trimester genetic sonography in patients with advanced maternal age and normal triple screen.

OBJECTIVE: To estimate the value of second-trimester genetic sonography in detecting fetal Down syndrome in patients with advanced maternal age (at least 35 years) and normal triple screen. METHODS: Since July 1999, a prospective collection and recording of all individual triple screen risks for fetal Down syndrome was initiated for all patients with advanced maternal age presenting in our ultrasound unit for second-trimester genetic sonography. Genetic sonography evaluated the presence or absence of multiple aneuploidy markers. Outcome information included the results of genetic amniocentesis, if performed, and the results of pediatric assessment and follow-up after birth. RESULTS: By June 2001, 959 patients with advanced maternal age and normal triple screen were identified. Outcome information was obtained in 768 patients. The median risk for fetal Down syndrome based on maternal age was 1:213 (range 1:37-1:274). The median risk for fetal Down syndrome based on triple screen results was 1:1069 (range 1:275-1:40,000). A total of 673 patients had normal genetic sonography, and none (0%) had Down syndrome; 95 had one or more aneuploidy markers present, and four (4.2%) had fetuses with Down syndrome. The triple screen risks for these four fetuses ranged from 1:319 to 1:833. CONCLUSION: This study suggests that patients with advanced maternal age and normal genetic sonography carried very little risk for Down syndrome. The use of genetic sonography may increase the detection rate of fetal Down syndrome in this group of pregnant women.

Value of a complete sonographic survey in detecting fetal abnormalities: correlation with perinatal autopsy.

OBJECTIVE: To determine the sensitivity of using a complete anatomic sonographic survey in detecting fetal abnormalities via correlation with perinatal autopsy results. METHODS: All perinatal autopsies (1994-2001) with positive findings for at least 1 fetal abnormality and performed by a single perinatal pathologist at our institution were retrospectively reviewed. From these cases, singleton fetuses who received prenatal sonography solely in our unit were identified. The sensitivity of sonography in detecting anomalous fetuses as well as fetal abnormalities and abnormalities by organ system was determined. Abnormalities were classified as major or minor In addition, findings from sonography and autopsy were compared, and their correlation was assigned to 1 of 3 categories. RESULTS: Of 88 fetuses identified, 85 had 1 or more abnormal structural sonographic findings (sensitivity for fetuses with anomalies, 97%). A total of 372 separate abnormalities were found on autopsy; of the 299 major and 73 minor abnormalities, prenatal sonography showed 224 (75%) and 13 (18%), respectively. There was either complete agreement or only minor differences between sonographic and autopsy findings in 57 (65%) of 88. The sensitivity of sonography in identifying abnormalities was greater than 70% in these systems: central nervous system, cardiac system, urinary system, extremities, genitalia, ribs, and hydrops. CONCLUSIONS: In experienced hands, sonography has 97% sensitivity in detecting anomalous fetuses when compared with perinatal autopsy results. Although the sensitivity of sonography in detecting major fetal abnormalities is 75%, the sensitivity for minor abnormalities is poor, even when using a complete anatomic sonographic survey. Although it has limitations, this type of survey is invaluable for both patients and physicians in diagnosing fetal abnormalities.