Conservative management of early-onset severe preeclampsia: comparison between randomized and observational studies a systematic review.

OBJECTIVE: To compare maternal and perinatal outcomes between randomized trials and observational studies in which conservative management was performed for more than 48 h in patients with early-onset severe preeclampsia. METHODOLOGY: We searched PubMed, LILACS, Cochrane and Google Scholar. The studies were divided in two groups: randomized and observational studies, from 1990 to 2018 that included patients with severe preeclampsia before 34 weeks of gestation with pregnancy prolongation ≥48 h but that did not include fetal growth restriction or HELLP syndrome at the beginning. The main variables recorded were maternal and perinatal complications. MAIN RESULTS: Forty-four studies met the inclusion criteria, and 5 of these were randomized. The average pregnancy prolongation was 9 days, with no difference between groups. Maternal complications were significantly more common in observational studies, RR = 0.71, 95% CI (0.54-0.93), p = .009. Perinatal complications were also significantly more common in observational studies (RR = 0.89, 95% CI (0.80-0.98), p = .01) at the expense of stillbirth and neonatal deaths. The percentages of cesarean sections were significantly higher in randomized studies, RR = 1.54, 95% CI (1.46-1.64). There were 2 maternal deaths, both in observational studies. CONCLUSION: Observational studies in which conservative management of early-onset preeclampsia is performed and do not include patients with fetal growth restriction or patients with HELLP syndrome and where at least 2 days of pregnancy prolongation is achieved are associated with significantly more maternal and perinatal complications.

Drugs for the Treatment and Prevention of Preterm Labor.

Preterm birth can be medically-indicated or spontaneous. Almost half of spontaneous preterm deliveries are preceded by preterm labor. Preterm labor is a clinical diagnosis characterized by regular uterine contractions (painful or painless) with concomitant cervical change. This article discusses the prevention and treatment of spontaneous preterm labor utilizing progesterone and tocolytic agents and provides management recommendations in patients with and without a history of prior spontaneous preterm birth.

Predicting asymptomatic cervical dilation in pregnant patients with short mid-trimester cervical length: A secondary analysis of a randomized controlled trial.

INTRODUCTION: Second trimester asymptomatic cervical dilation is a significant risk factor for early preterm birth. The objective of this study is to evaluate whether transvaginal ultrasound cervical length (CL) predicts asymptomatic cervical dilation on physical exam in women with short cervix (CL ≤25 mm) and no prior preterm birth. MATERIAL AND METHODS: Secondary analysis of a randomized trial on pessary in asymptomatic singletons without prior preterm birth diagnosed with CL ≤25 mm between 18+0/7 and 23+6/7  weeks. Participants had transvaginal ultrasound and physical cervical exam and were randomized to pessary or no pessary with all patients with cervical length ≤20 mm offered vaginal progesterone. The primary outcome was to determine whether CL was predictive of asymptomatic physical cervical dilation ≥1 cm using receiver operating characteristic curve. RESULTS: In all, 119 women were included. Based on receiver operating characteristic curve, CL ≤11 mm was best predictive of cervical dilation ≥1 cm, with 75% sensitivity, 80% specificity, and area under the curve 0.73 (0.55-0.91), P = 0.009. Cervical length ≤11 mm had increased incidence of cervical dilation ≥1 cm on physical exam (30% vs 3%, odds ratio 12.29 (3.05-49.37) P < 0.001) with a negative predictive value of 97%. Patients with ≥1 cm dilation had increased preterm birth <37 weeks (75% vs 39%, P = 0.03) compared to those not dilated. Women with a CL ≤11 mm had increased preterm birth <37 weeks (77% vs 31%, P < 0.001), preterm birth <34 weeks (63% vs 22%, P < 0.001), and lower birthweight (1552 ± 1047 vs 2560 ± 1072 g, P < 0.001) compared to women with CL >11 mm. CONCLUSIONS: Among singletons without prior preterm birth diagnosed with short cervix (≤25 mm), CL ≤11 mm may identify a subgroup of patients at high risk for asymptomatic cervical dilation and poor perinatal outcome. Physical exam should be considered and adjunctive preterm birth prevention measures should be studied in singletons with CL ≤11 mm.

Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta-analysis.

OBJECTIVES: To evaluate the effectiveness of cervical pessary for preventing spontaneous preterm birth (SPTB) in singleton gestations with a second trimester short cervix. METHODS: Electronic databases were searched from their inception until February 2016. We included randomized clinical trials (RCTs) comparing the use of the cervical pessary with expectant management in singletons pregnancies with transvaginal ultrasound cervical length (TVU CL) ≤25 mm. The primary outcome was incidence of SPTB <34 weeks. The summary measures were reported as relative risk (RR) with 95% confidence interval (CI). RESULTS: Three RCTs (n = 1,420) were included. The mean gestational age (GA) at randomization was approximately 22 weeks. The Arabin pessary was used as intervention in all three trials, and was removed by vaginal examination at approximately 37 weeks. Cervical pessary was not associated with prevention of SPTB <37 (20.2% vs 50.2%; RR 0.50, 95% CI 0.23 to 1.09), <34, <32, and <28 weeks, compared to no pessary. No differences were found in the mean of GA at, interval from randomization to delivery, incidence of preterm premature rupture of membranes and of cesarean delivery, and in neonatal outcomes. The Arabin pessary was associated with a significantly higher risk of vaginal discharge. CONCLUSIONS: In singleton pregnancies with a TVU CL ≤25mm at 200 -246 weeks, the Arabin pessary does not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. Individual patient data meta-analysis may clarify whether cervical pessary may be beneficial in subgroups, such as only singleton gestations without prior SPTB or by different CL cutoffs.

Cervical pessary for preventing preterm birth in twin pregnancies with short cervical length: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the effectiveness of cervical pessary for preventing spontaneous preterm birth (SPTB) in twin pregnancies with an asymptomatic transvaginal ultrasound cervical length (TVU CL) in the second trimester. METHODS: We performed a meta-analysis including all randomized clinical trials (RCTs) comparing the use of cervical pessary (i.e. intervention group) with expectant management (i.e. control group). The primary outcome was incidence of SPTB <34 weeks. RESULTS: Three trials, including 481 twin pregnancies with short cervix, were analyzed. Two RCTs defined short cervix as TVU CL ≤25 mm and one as TVU CL ≤38 mm. Pessary was not associated with prevention of SPTB, and the mean gestational age at delivery and the mean latency were similar in the pessary group compared to the control group. Moreover, no benefits were noticed in neonatal outcomes. CONCLUSIONS: Use of the Arabin pessary in twin pregnancies with short TVU CL at 16-24 weeks does not prevent SPTB or improve perinatal outcome.

Racial/Ethnic Disparities in Measures of Self-reported Psychosocial States and Traits during Pregnancy.

Background The aim of this study was to determine whether racial/ethnic differences in psychosocial measures, independent of economic status, exist among a large population of pregnant nulliparas. Methods Between October 2010 and September 2013, nulliparous women at eight U.S. medical centers were followed longitudinally during pregnancy and completed validated instruments to quantify several psychosocial domains: Cohen Perceived Stress Scale, trait subscale of the Spielberger Anxiety Inventory, Connor-Davidson Resilience Scale, Multidimensional Scale of Perceived Social Support, Krieger Racism Scale, Edinburgh Postnatal Depression Scale, and the Pregnancy Experience Scale. Scores were stratified and compared by self-reported race, ethnicity, and income. Results Complete data were available for 8,128 of the 10,038 women enrolled in the study. For all measures, race and ethnicity were significantly associated (p < 0.001) with survey scores. Non-Hispanic black (NHB) women were most likely to score in the most unfavorable category for all measures, with the exception of the Pregnancy Experience Scale. The magnitude of these differences did not differ by income status (interaction, p > 0.05) except on the Krieger racism survey and the Edinburgh depression survey, which were exacerbated among NHB women with higher income (interaction, p < 0.001). Conclusion Significant racial/ethnic disparities, independent of income status, exist in psychosocial measures during pregnancy.

Health Literacy in Unauthorized Mexican Immigrant Mothers and Risk of Developmental Delay in their Children.

The incidence of developmental delay and early intervention (EI) service utilization is not well documented among unauthorized Mexican immigrants, a vulnerable population. Individual interviews were conducted in Spanish with Mexican born women receiving maternal health care. Children 12-60 months of age were screened for developmental delay using the Ages and Stages Questionnaire. 12 % (n = 8) of children assessed (n = 65) were at risk for developmental delay. Of those at risk 38 % (n = 3) participated in EI. An additional 26 % of the children (n = 17) qualified for further monitoring, and of those 59 % (n = 10) received EI. Women with low health literacy had more than four times the odds of having a child with risk of developmental delay (aOR 4.4; 95 % CI 1.3-15.4). Developmental delay was associated with low maternal health literacy in unauthorized Mexican immigrants; however, rates of self-reported EI use in this population are higher than those seen nationally.

Preterm birth risk at high altitude in Peru.

OBJECTIVE: High altitude has been implicated in a variety of adverse pregnancy outcomes including preeclampsia and stillbirth. Smaller studies show conflicting data on the association between high altitude and preterm birth (PTB). The objective of this study was to assess the association between altitude and PTB. STUDY DESIGN: A retrospective cohort study was performed using data from the Perinatal Information System, which includes deliveries from 43 hospitals in Peru from 2000 through 2010. Altitude was classified into the following categories: low (0-1999 m), moderate (2000-2900 m), and high (3000-4340 m). The primary outcome was PTB (delivery <37 weeks). Secondary outcomes were cesarean delivery and small for gestational age (SGA). Deliveries less than 23 weeks are not included in the database. χ(2) analyses were performed to compare categorical variables, and a logistic regression was used to calculate the odds ratios and control for confounders. Clustering by hospital was accounted for using generalized estimating equations. RESULTS: A total of 550,166 women were included (68% low, 15% moderate, 17% high altitude). The overall PTB rate was 5.9%, with no difference in the PTB rate among the 3 altitudes (5.6%, 6.2%, 6.8%, P = .13). There was a significant difference in cesarean rates (28.0%, 26.6%, 20.6%, P < .001) with a 34% decreased risk at high vs low altitude adjusted for confounders (adjusted odds ratio, 0.66; 95% confidence interval, 0.51-0.85). There was a difference in SGA (3.3%, 3.6%, 5.0%, P = .02) with a 51% increased risk at high vs low altitude adjusted for confounders (adjusted odds ratio, 1.49; 95% confidence interval, 1.14-1.93). CONCLUSION: High altitude is not associated with PTB. At high altitude, the cesarean rate was reduced and the SGA rate was increased.

The use of magnesium sulfate for women with severe preeclampsia or eclampsia diagnosed during the postpartum period.

This was a systematic review of randomized controlled trials comparing anticonvulsants with placebo or no anticonvulsant for prevention (a) of eclampsia in women with severe preeclampsia diagnosed during the postpartum period or diagnosed before delivery but without previous treatment and (b) prevention of seizures recurrence in women with eclampsia postpartum. We did not find study with full inclusion criteria. However, a total of two randomised controlled trials meet inclusion criteria as subgroup analysis; one for severe preeclampsia diagnosed during the postpartum period and one for eclampsia postpartum. For severe preeclampsia diagnosed during postpartum, there was no clear difference between the groups reporting eclampsia (relative risk: 0.54, 95% confidence interval: 0.16-1.80). For seizure recurrence, magnesium sulfate was superior to diazepam, but there was no significant difference compared with phenytoin. No conclusion can be drawn on the role of magnesium sulfate post partum as established in antepartum pre-eclampsia/eclampsia management because of lack of powered randomised controlled trials.

Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial.

OBJECTIVE: The objective of the study was to determine whether expectant management of severe preeclampsia prior to 34 weeks of gestation results in improved neonatal outcome in countries with limited resources. STUDY DESIGN: This was a randomized clinical trial performed in 8 tertiary hospitals in Latin America. Criteria of randomization included gestational age between 28 and 33 weeks' gestation and the presence of severe hypertensive disorders. Patients were randomized to steroids with prompt delivery (PD group) after 48 hours vs steroids and expectant management (EXM group). The primary outcome was perinatal mortality. RESULTS: A total of 267 patients were randomized, 133 to the PD group and 134 to the EXM group. Pregnancy prolongation was 2.2 days for the PD group vs 10.3 days for the EXM group (P = .0001). The rate of perinatal mortality (9.4% vs 8.7%; P = .81; relative risk [RR], 0.91; 95% confidence interval [CI], 0.34-1.93) was not improved with expectant management, and neither was the composite of neonatal morbidities (56.4% vs 55.6%; P = .89; RR, 01.01; 95% CI, 0.81-1.26). There was no significant difference in maternal morbidity in the EXM group compared with the PD group (25.2% vs 20.3%; P = .34; RR, 1.24; 95% CI, 0.79-1.94). However, small gestational age (21.7% vs 9.4%; P = .005; RR, 2.27; 95% CI, 1.21-4.14) and abruption were more common with expectant management (RR, 5.07; 95% CI, 1.13-22.7; P = .01). There were no maternal deaths. CONCLUSION: This study does not demonstrate neonatal benefit with expectant management of severe preeclampsia from 28 to 34 weeks. Additionally, a conservative approach may increase the risk of abruption and small for gestational age.

Patient satisfaction with the laborist model of care in a large urban hospital.

BACKGROUND: The obstetric practice environment is evolving to include more laborists staffing obstetric units, with the hope of improving quality of care and provider satisfaction, yet there are scant data on the impact of a laborist care model on patient satisfaction or delivery outcomes. We sought to assess patient satisfaction after implementation of the laborist model of obstetric care in a large urban teaching hospital. METHODS: Postpartum patients were asked to complete an anonymous survey assessing their satisfaction with care, particularly with regard to the laborist model. Survey questions included rating the overall experience of labor and delivery. All responses were based on a five-point Likert scale. Press-Ganey results were compared from before and after initiation of the model. Descriptive statistics were used to analyze the results. RESULTS: Post-laborist implementation obstetric and delivery experience surveys were collected from 4166 patients, representing a 54% response rate. Ninety percent of patients reported that they were highly satisfied with the overall experience in the labor and delivery unit. A subgroup was asked to rate their experience with the practitioner for their current delivery. Of the 687 respondents, 75% answered excellent, 18% answered good/very good, and 3.4% answered neutral. Eighty-five percent of this subgroup stated that they were informed during prenatal care that they may be delivered by someone other than the practitioner or group that they saw during the pregnancy. Thirty-seven percent (n = 1553) of the total respondents reported that they had had a previous delivery at this institution, 97% (n = 1506) of whom stated "yes" to having their next delivery at this institution. Press-Ganey results were similarly favorable in both time periods (91.3 [n = 811] versus 93.4 [n = 747], P = 0.08). CONCLUSION: Patient satisfaction does not appear to be adversely affected by initiation of the laborist model. Additional research is needed to understand further the implications of this model for provider satisfaction, and maternal and neonatal outcomes.

Can transabdominal ultrasound identify women at high risk for short cervical length?

OBJECTIVE: To determine whether transabdominal cervical length screening could identify women at high risk for having a short cervix on transvaginal ultrasound. DESIGN: Retrospective cohort study. SETTING: Tertiary referral center. POPULATION: A total of 703 patients with a singleton pregnancy at 18 to 23(+6) weeks of gestation who underwent transabdominal and transvaginal cervical length assessment during anatomy ultrasound at a single institution between January 2007 and October 2011. METHODS: Electronic medical records were reviewed to identify women who met the study criteria. MAIN OUTCOME MEASURES: The primary outcome was the number of women with a short transabdominal cervical length (defined as ≤ 30 mm) who needed to undergo transvaginal ultrasound to detect one woman with a short transvaginal cervical length of ≤ 20 mm. RESULTS: In all, 703 patients were included in the primary analysis; 3.42 women with transabdominal cervical length ≤ 30 mm needed to undergo transvaginal ultrasound to detect one woman with transvaginal ultrasound cervical length ≤ 20 mm. Of women with short transvaginal cervical length ≤ 20 mm, 89.8% had a transabdominal measurement ≤ 30 mm and 96.7% had a transabdominal measurement ≤ 33 mm. CONCLUSIONS: Screening of transabdominal cervical length may represent a useful strategy for detecting women with short cervix on transvaginal ultrasound.

Transvaginal cervical cerclage: evidence for perioperative management strategies.

The objective was to review the evidence supporting various perioperative technical and management strategies for transvaginal cervical cerclage. We performed MEDLINE, PubMed, EMBASE, and COCHRANE searches with the terms, cerclage, cervical cerclage, cervical insufficiency, and randomized trials, plus each technical aspect (eg, suture, amniocentesis, etc) considered. The search spanned 1966 through September 2012 and was not restricted by language. Each retrieved manuscript was carefully evaluated, and any pertinent references from the reports were also obtained and reviewed. All randomized trials covering surgical and selected perioperative, nonsurgical aspects of cerclage were included in the review. The evidence was assessed separately for history-, ultrasound-, and physical examination-indicated cerclage. Evidence levels according to the new method outlined by the US Preventive Services Task Force were assigned based on the evidence. There are no grade A high-certainty recommendations regarding technical aspects of transvaginal cervical cerclage. Grade B moderate-certainty recommendations include performing a fetal ultrasound before cerclage to ensure fetal viability, confirm gestational age, and assess fetal anatomy to rule out clinically significant structural abnormalities; administering spinal, and not general, anesthesia; performing a McDonald cerclage, with 1 stitch, placed as high as possible; and outpatient setting. Unfortunately, no other recommendations can be made regarding the other technical aspects of cerclage.