Labor Induction versus Expectant Management in Low-Risk Nulliparous Women.

BACKGROUND: The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain. METHODS: In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days of gestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was cesarean delivery. RESULTS: A total of 3062 women were assigned to labor induction, and 3044 were assigned to expectant management. The primary outcome occurred in 4.3% of neonates in the induction group and in 5.4% in the expectant-management group (relative risk, 0.80; 95% confidence interval [CI], 0.64 to 1.00). The frequency of cesarean delivery was significantly lower in the induction group than in the expectant-management group (18.6% vs. 22.2%; relative risk, 0.84; 95% CI, 0.76 to 0.93). CONCLUSIONS: Induction of labor at 39 weeks in low-risk nulliparous women did not result in a significantly lower frequency of a composite adverse perinatal outcome, but it did result in a significantly lower frequency of cesarean delivery. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ARRIVE ClinicalTrials.gov number, NCT01990612 .).

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.

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.

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.

Outcomes after periviable ultrasound-indicated cerclage.

BACKGROUND: Cerclage placed for a sonographically short cervix has been shown to reduce the risk of preterm delivery in women with a history of prior preterm birth. While short cervix is traditionally placed before viability, the threshold gestational age at which viability is achieved continues to decrease, and, as a result, a larger subset of women may be ineligible to receive this potentially beneficial procedure. OBJECTIVE: To evaluate the association between obstetric outcomes and perioperative complications after placement of an ultrasound-indicated cerclage at periviability compared to placement in the previable period. METHODS: This retrospective cohort study of patients who underwent ultrasound-indicated cerclage evaluated obstetric outcomes and perioperative complications based on gestational age at cerclage placement. Ultrasound-indicated cerclage was considered to have been placed at periviability if placed at 22 to <24 weeks (exposed) and at previability if placed at 16 to <22 weeks gestational age (unexposed). The primary outcome was preterm delivery <36 weeks. Secondary outcomes included mean gestational age at delivery, preterm delivery <32 weeks, <28, and <24 weeks, preterm premature rupture of membranes (PPROM), chorioamnionitis, and perioperative complications. Adjusted analyses were performed to account for demographic and obstetric factors. RESULTS: Of the 426 patients included in the analysis, 94 (22%) had cerclage placed between ≥22 weeks to <24 weeks, while 332 (78%) had cerclage placed at <22 weeks. On univariate analysis, women who had a periviable cerclage placed were less likely to have a recurrent preterm delivery <36 weeks compared to women with previable cerclage placement (26.6 versus 38.3%, respectively, p = .04). The adjusted model did not demonstrate a significant difference in risk for preterm delivery <36 weeks associated with periviable versus previable cerclage (odds ratio 0.66, 95%CI 0.37-1.17). Secondary outcomes were similar between the previable and periviable groups, including mean gestational age at delivery (35.1 versus 36.2 weeks, respectively, p = .08) and preterm delivery before 32-week gestation (20.7 versus 13.8%, respectively, p = .17). Intraoperative and postoperative complications were rare and rates were similar between groups. CONCLUSIONS: Obstetric outcomes between patients receiving periviable and previable cerclage are similar. Ultrasound-indicated cerclage placement is associated with a relatively low rate of complications. Given the evidence supporting benefit of cerclage for women with short ultrasound cervical length and prior preterm birth, our findings demonstrate that benefits of placement at ≥22 weeks to <24 weeks may outweigh risks.

Buttock Necrosis after Uterine Artery Embolization for Delayed Hysterectomy in Placenta Percreta.

Background. Morbidly adherent placenta (MAP) is increasing in incidence and is commonly associated with maternal hemorrhage and cesarean hysterectomy. Uterine artery embolization (UAE) may be utilized in the conservative management of placenta percreta to potentially reduce blood loss. The incidence of complications from UAE in the conservative management of placenta percreta is poorly described. To our knowledge, we present the first reported case of buttock necrosis in this setting. Case. A 39-year-old gravida nine para two with placenta percreta who underwent conservative management with UAE complicated by right buttock necrosis. Conclusion. While UAE may potentially decrease blood loss, it is not without risk. More studies must be performed in order to quantify those risks and determine the clinical utility of UAE.

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.

Prenatal sonographic diagnosis of congenital heart disease and intrauterine growth restriction: a case-control study.

PURPOSE: To determine the prevalence of intrauterine growth restriction (IUGR) in cases of congenital heart disease (CHD) and to evaluate whether the prenatal diagnosis of isolated CHD was a significant risk factor for IUGR. METHODS: We conducted a retrospective case-control study of prenatally detected CHD with delivery at >/=20 weeks' gestation between January 1, 1998, and December 31, 2001. Four groups were analyzed: (1) all cases with CHD, (2) after exclusion of abnormal karyotype, (3) after exclusion of abnormal karyotype and prenatally diagnosed extracardiac anomaly, and (4) after exclusion of abnormal karyotype and prenatally and postnatally diagnosed extracardiac anomaly. The prevalence of IUGR was determined in each of the 4 study groups and was compared with controls. RESULTS: There were 13,395 deliveries at >/=20 weeks' gestation. Of the 180 cases of CHD, 22.8% were associated with IUGR compared with 11.6% of controls (p < 0.01). In contrast, there was no statistically significant difference in the prevalence of IUGR in the 140 cases of isolated CHD compared with controls (12.9% versus 10.0%). CONCLUSION: The prenatal detection of isolated CHD does not seem to be associated with IUGR.

Prenatal diagnosis of conotruncal malformations: diagnostic accuracy, outcome, chromosomal abnormalities, and extracardiac anomalies.

The purpose of this study was to determine whether continuing experience in prenatal diagnosis of conotruncal malformations (CTMs) has resulted in improved diagnostic accuracy and outcome. Previous reports have demonstrated particular difficulty with ascertainment of the spatial relationship of the great arteries in patients with CTM. The prognosis for fetuses with CTM was poor. Medical records of 113 consecutive fetuses in whom a CTM (tetralogy of Fallot [TOF], double-outlet right ventricle [DORV], type B aortic arch interruption, transposition of the great arteries [TGA], and persistent truncus arteriosus [TA]) was diagnosed antenatally between 1994 and 2003 were reviewed. The diagnosis of the 91 fetuses with CTM included TOF (n = 32), TGA (n = 29), DORV (n = 22), and TA (n = 8). The great arterial spatial relationship was diagnosed accurately in 84 of the 91 (92%) live-born infants. In the other seven infants with DORV, the great arterial spatial relationship was identified inaccurately. The overall survival to 30 days was 85 of 91 (93%). Twenty-three of 91 (25%) patients had extracardiac anomalies. Genetic diagnosis (amniocentesis) was obtained in 63 of 94 patients; 11 (17%) had chromosomal abnormalities. Maternal glucose tolerance results were obtained in 65 of the 91 patients and were abnormal in 25 of 65 (38%). Prenatal diagnostic accuracy of conotruncal malformations is excellent; the arterial spatial relationship of DORV remains problematic. The populations of fetuses with CTMs who continue to develop to term have an excellent prognosis.

Markers of periodontal infection and preterm birth.

OBJECTIVE: This study was undertaken to explore the relationship between clinical, microbiologic, and serologic markers of periodontitis and preterm birth (PTB). STUDY DESIGN: We compared women with a singleton gestation giving birth before the 37th week (cases, n = 83) with term delivery controls (n = 120). Periodontal examination and collection of dental plaque and blood samples were performed within 48 hours after delivery. Microbial levels and maternal immunoglobulin G titers to oral bacteria were analyzed. Multivariate regression models were fitted controlling for common covariates. RESULTS: Cases showed greater mean attachment loss (1.7 vs 1.5 mm, P = .003) and higher prevalence of periodontitis (30.1% vs 17.5%, P = .027). No differences in microbial or serum antibody levels were detected between the groups. Logistic regression revealed that PTB was associated with attachment loss (adjusted odds ratio: 2.75, 95% CI: 1.01-7.54). Linear regression indicated a significant ( P = .04) association between attachment loss and low birth weight (LBW). CONCLUSION: The data support the notion that periodontitis is independently associated with PTB and LBW.