Expectant Management In Women Research Articles

Misoprostol versus expectant management in women with incomplete first-trimester miscarriage after failed primary misoprostol treatment: A randomized clinical trial.

To compare the effectiveness and safety of repeat misoprostol versus expectant management in women with first-trimester incomplete miscarriage who have been initially treated with misoprostol. The study was an open-labeled randomized controlled trial including women with an incomplete first-trimester miscarriage after administration of misoprostol. The participants were randomly assigned to vaginal misoprostol or expectant management using a computer-generated table of random numbers. The primary outcome was the number of women with a complete miscarriage at 1week. Eighty-eight women (44 women in each group) were analyzed. The rate of complete miscarriage at 1week was significantly higher in the misoprostol group than the expectant management group-29 (69.0%) versus 7 (16.7%) (P<0.001), respectively. Women in the misoprostol group were more satisfied (7.00±0.77 vs 4.57±1.61, P<0.001) but reported more pain (7.95±1.85 vs 5.26±1.08, P<0.001) than women in the expectant group. The misoprostol group reported more adverse effects than the expectant management group (P<0.001). In women with an incomplete first-trimester miscarriage who were initially treated with misoprostol, repeat administration of misoprostol was more effective than expectant management for achieving complete miscarriage at 1week. However, misoprostol was associated with more adverse effects. Clinicaltrials.gov: NCT03148561.

252 Degree of proteinuria and duration of expectant management in women with severe preeclampsia

To evaluate the association between the degree of proteinuria and duration of expectant management (EM) and other perinatal outcomes in women with severe preeclampsia (SPE). Retrospective cohort study of women with SPE delivering live, non-anomalous singletons at 23-34 weeks gestational age (GA) at a single tertiary center (2016-2018). Women with proteinuria assessment (24-hour total urine protein or urine protein:creatinine ratio extrapolation) within 3 days of SPE diagnosis were included. Women delivered for an indication other than SPE, i.e., preterm labor, were excluded. Women were categorized by degree of proteinuria (mg): none (less than or equal to 300), mild (301-1000), moderate (1001-3000), and massive (greater than or equal to 3001). The primary outcome was the proportion of potential EM time achieved (%EM), i.e., days of EM achieved divided by maximum potential EM time (days from SPE diagnosis to 34 weeks). Secondary outcomes included delivery GA, days of EM, and perinatal outcomes. Bivariable and multivariable analyses compared outcomes across groups. Of 285 women included, 21% had no proteinuria, 33% mild, 19% moderate, and 27% massive. Demographics differed between groups with respect to GA at diagnosis, age, parity, chronic hypertension, and kidney function (Table 1). %EM was not significantly different between groups (Table 2; adjusted β coefficient 0.5 (95% CI -0.5, 1.4) for mild proteinuria vs none, -0.5 (95% CI -1.6, 0.6) for moderate proteinuria vs none, and -0.6 (95% CI -1.6, 0.5) for massive proteinuria vs none). Increasing proteinuria was associated with earlier delivery GA but not days of EM (Table 2). However, massive proteinuria was associated with an increased odds of maternal (aOR 2.3, 95% CI 1.0, 5.3) and neonatal (aOR 2.5, 95% CI 1.2, 5.4) composite morbidities, compared to no proteinuria (Table 2). Among women with SPE, the degree of proteinuria was not associated with duration of EM. However, massive proteinuria, compared to no proteinuria, was associated with higher odds of maternal and neonatal adverse outcomes.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

504 Fetal growth restriction and latency from diagnosis to delivery in early onset preeclampsia

Early onset preeclampsia (PE) is associated with increased maternal and neonatal morbidity, including fetal growth restriction (FGR). Data on the benefit of expectant management in women with early onset PE with severe features (SF) in the setting of FGR are limited. Therefore, we aimed to determine whether FGR shortens the latency from PE diagnosis till delivery, in women undergoing expectant management of early onset PE with SF. Retrospective chart review of women with early onset PE with SF that developed < 34 weeks of gestation, who delivered at a single tertiary care center between 2011-2020. Women were excluded if delivery was planned after completion of antenatal corticosteroids, fetal demise at time of PE diagnosis or fetal anomaly. Our primary outcome was latency from diagnosis of PE to delivery. Sub-analysis was performed to further evaluate the FGR group based on estimated fetal weight (EFW) ≤3% or abnormal Doppler studies defined as >95% systolic/diastolic umbilical artery Doppler (UAD) flow, absent or reversed UAD. Of 261 patients identified, 236 patients met criteria for analysis, with 80 (33.6%) FGR and 156 (66.4%) appropriately grown for gestational age (AGA) fetuses. There were no differences in maternal age, BMI at time of delivery, ethnicity/race, nulliparity, chronic hypertension or need for acute anti-hypertensive therapy. Patients with FGR were more likely to use tobacco and be delivered via cesarean compared with those with AGA fetuses. Pregnancies complicated by FGR were diagnosed with PE and delivered at earlier GA compared with those with AGA fetuses. (Table 1) There were no differences in latency between the two groups with median of 3 [IQR 1-5] vs 2 [1-4] days. There were no differences in the composites of maternal or neonatal outcomes. Similar patterns were observed in sub-analysis of FGR by EFW ≤3% and abnormal UAD studies. (Table 2) In patients with early onset PE with SF, FGR did not impact latency or worsen short term maternal and neonatal outcomes. Further research is needed to determine long term maternal and child outcomes.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Perinatal death in a term fetal growth restriction randomized controlled trial: the paradox of prior risk and consent

The disproportionate intrauterine growth intervention trial at term was an intention to treat analysis and compared labor induction with expectant monitoring in pregnancies complicated by fetal growth restriction at term and showed equivalence for neonatal outcomes. To evaluate trial participation bias and to examine the generalizability of the results of an obstetrical randomized trial. We used data from participants and nonparticipants of a randomized controlled trial-the disproportionate intrauterine growth intervention trial at term (n=1116) -to perform a secondary analysis. This study compared induction of labor and expectant management in women with term growth restriction. Data were collected in the same manner for both groups. Baseline characteristics and neonatal and maternal outcomes were compared. The primary outcome was a composite measure of adverse neonatal outcome. Secondary outcomes were delivery by cesarean delivery and instrumental vaginal delivery; length of stay in the neonatal intensive care, neonatal ward, and the maternal hospital; and maternal morbidity. Nonparticipants were older, had a lower body mass index, had a higher level of education, smoked less, and preferred expectant management. The time between study inclusion and labor onset was shorter in participants than in nonparticipants. Notably, 4 perinatal deaths occurred among nonparticipants and none among participants. Among nonparticipants, there were more children born with a birthweight below the third centile. The nonparticipants who had expectant management were monitored less frequently than the participants in both the intervention and the expectant arm. We found less favorable outcomes and more perinatal deaths in nonparticipants. Protocol-driven management, differences between participants and nonparticipants, or the fact that nonparticipants had a preference for expectant management might explain the findings.

Planned Early Delivery or Expectant Management for Late Preterm Preeclampsia (PHOENIX): A Randomized Controlled Trial

(Lancet. 2019;394:1181–1190) Preeclampsia occurs in 2% to 3% of pregnant women and is associated with substantial maternal and neonatal morbidity and mortality. Prompt delivery is the recommended management for preeclamptic women after 37 weeks’ gestation, as this will decrease the risk of maternal complications while minimally affecting risk to the neonate at this gestational age. However, it is unclear what the best management strategy is for women who develop preeclampsia between 34 and 37 weeks’ gestation. In these cases, complications related to expectant management (EM), such as stillbirth or worsening fetal growth restriction and increased maternal morbidity associated with continuing the pregnancy, must be weighed against the neonatal complications associated with early delivery (infant immaturity). Current guidelines in the UK recommend EM until 37 weeks’ gestation, with earlier delivery if severe preeclampsia or other complications arise. This study from the UK compared earlier initiation of delivery with EM in women diagnosed with preeclampsia between 34 and &lt;37 weeks gestation.

Evaluation of maternal serum biomarkers in predicting outcome of successful expectant management of tubal ectopic pregnancies

ObjectiveTo assess the value of multiple serum biomarkers for the prediction of successful outcome of expectant management in women with tubal ectopic pregnancy (TEP). Study designWomen with a conclusive ultrasound diagnosis of TEP had a blood test to measure β-human chorionic gonadotropin (β-hCG), progesterone, inhibin A, activin A and high sensitivity C-reactive protein (hsCRP) at the initial visit. Women presenting with pain, serum β-hCG ≥ 1500 IU, evidence of a live ectopic pregnancy or a significant haemoperitoneum were advised to have emergency surgery. Women eligible for expectant management were followed-up prospectively until serum β-hCG declined to non-pregnant level or surgical treatment was required. ResultsA total of 93 women with a TEP were included in the final cohort. Emergency surgery was carried out in 42/93 (45 %) of women whilst 51/93 (55 %) were managed expectantly. Of the latter group, 42/51 (82 %) had successful expectant management and 9/51(18 %) required surgical procedure after a period of follow up. On multi-variable analysis, only higher values of serum β-hCG and progesterone at the initial visit were associated with a lower chance of successful expectant management of TEP. A one-unit increase in either variable on the log-scale was associated with an approximate 20-fold reduction in the odds of a successful outcome. Conclusion(s)Serum β-hCG and progesterone were significantly lower in women who had successful expectant management of TEP. Other biomarkers under consideration were not significantly different in women with successful and failed expectant management.

Labor Induction at 39 Weeks Versus Expectant Management in Women With Prior Cesarean Delivery [22P

INTRODUCTION: To compare maternal and neonatal outcomes between elective induction (EIOL) and expectant management (EM) in low risk women with a prior cesarean delivery. METHODS: Records of women with a prior cesarean and whose plan of delivery was a trial of labor (TOLAC) were reviewed. Patients who reached 39 weeks and were low risk were included and divided into 2 groups. Those who were induced electively between 39 weeks 0 days and 39 weeks 6 days (EIOL) versus those who were not (EM). Low risk was defined as absence of a maternal or fetal indication for delivery prior to 41 weeks 6 days. The primary outcome was a composite of adverse neonatal outcomes. Secondary outcomes included repeat cesarean delivery (CD) and maternal morbidities. RESULTS: From July 2014–July 2019, 552 low risk women underwent TOLAC: 317 women in the EM and 235 in the EIOL group. The primary outcome occurred in 5.38% in the EM group and 3.40% in the EIOL group (OR 0.62, 95% CI 0.23–1.55). The frequency of CD was 31.86% in the EM group and 26.38% in the EIOL group (OR 0.766, 95% CI 0.52–1.13). CONCLUSION: Elective induction of labor at 39 weeks among low risk women with a history of prior cesarean section was not associated with an increase in perinatal morbidity, and was associated with lower rates of hysterotomy-associated complications and medically-indicated delivery. It is reasonable to offer elective induction of labor at 39 weeks to women who are candidate for TOLAC.

Hospital Versus Home Management in Women with Pre-Labor Rupture of Membranes: RCT

Abstract Background Pre-labor rupture of membranes (premature rupture of membranes (PROM) is defined as rupture of fetal membranes before onset of labor in women after 37 weeks of gestation. And it accounts for 10% of all gestations. Latent period is the interval between PROM and time of onset of labor. More accurate prediction of latency period could help prepare patients for anticipated length of hospital stays. Objective To find out if there is difference between home management and hospital expectant management in women with PROM as regard maternal and fetal outcomes. Patients and Methods Our study is a prospective randomized controlled trial to compare hospital versus home management in women with PROM, whom came to Ain Shams Maternity Hospital, as regard latency period, successful vaginal delivery, chorioamnionitis, NICU admission, and time from rupture of membrane till delivery, who attending the emergency room during the period from June 2017 till June 2018. A total of 152 pregnant women were included in this study who met inclusion and exclusion criteria, they divided into 2 groups, each 76 woman. Group A discharged home after initial assessment, Group B admitted to hospital. Results The present study found that there was a highly statistically significant difference (p &amp;lt; 0.001) between home group and hospital group as regard length of hospital stay. While there was no significant correlation (p &amp;gt; 0.05) between the two groups as regard mode of delivery or adverse maternal or neonatal outcomes. Conclusion As regard home management for women with PROM in comparison with hospital management, they had longer latent period as well as longer time interval between PROM and delivery, but had a shorter hospitalization stay without negative impact on maternal or fetal outcome. In times of increasing financial pressure on the medical system, outpatient management for PROM seems to be a viable option. Also multiparous women were more satisfied with their care, and reported that they ‘would participate in the study again’ if they were cared for at home rather than in hospital.

Outcomes of prophylactic and emergency cerclage versus expectant management for cervical insufficiency: a single-center retrospective, comparative study

Aim: To compare the outcomes after prophylactic cerclage, emergency cerclage, and expectant management in women with cervical insufficiency. Materials and Methods: From 2011 to 2015, Eulji University Hospital’s database was retrospectively analyzed to identify women with cervical insufficiency without premature rupture of membranes (PROM), clinical chorioamnionitis, or labor pain from 12 to 26 weeks of gestation. Gestational age at delivery, term delivery rate, after-34-weeks-of-gestation delivery rate, intensive-careunit admission rate, neonatal sepsis, and neonatal mortality rate were compared between each group. Results: Forty-eight women underwent prophylactic cerclage: 56 emergency cerclage and 21, expectant management. Prolongation of pregnancy was longer in the prophylactic cerclage group than in the emergency group (22.8 ± 2.7 weeks vs. 13.3 ± 6.1 weeks, p &lt; 0.001). Preterm delivery rate &lt; 34 gestational weeks was significantly higher in the emergency cerclage group than the prophylactic group (37.5% vs. 14.6%, p = 0.009). Elevated pre-cerclage C-reactive protein (CRP) was associated with delivery before 34 weeks in the emergency cerclage group [odds ratio (OR): 15.849; 95% confidence interval (CI): 1.289-194.898, p = 0.031]. Comparing the emergency cerclage and expectant groups, prolongation of pregnancy was higher in the emergency group than the expectant group (13 ± 6.1 weeks vs. 8 ± 5.7 weeks, p = 0.002). However, there were no significant differences between the two groups regarding preterm delivery &lt; 34 weeks and perinatal outcomes. Conclusions: Preterm delivery rate &lt; 34 gestational weeks was higher in the emergency cerclage group than the prophylactic group. There were no significant differences between the emergency cerclage and the expectant groups in pregnancy and perinatal outcomes.

Induction Compared to Expectant Management for Women With Gestational Diabetes at Term [26L

INTRODUCTION: To evaluate the risk of cesarean delivery by gestational week of induction versus expectant management in women with gestational diabetes mellitus (GDM). METHODS: We conducted a retrospective cohort study of term women with a singleton gestation and GDM who underwent a trial of labor and delivered between January 2016 and July 2018 at a tertiary care center. Outcomes were compared between women who underwent induction versus expectant management during a given gestational week. The primary outcome was mode of delivery. Maternal and pregnancy characteristics were compared between women in each group. RESULTS: Of 401 women with GDM, women induced during the 37th, 38th, and 39th weeks had greater body mass index than those who were expectantly managed and women induced during the 37th and 38th weeks were more likely to have hypertensive disorders of pregnancy. At all gestational ages, women who were induced were less likely to be diet-controlled. Overall, induction during the 39th week was associated with a lower rate of cesarean delivery, 14% compared to 28% with expectant management (P&lt;0.01). This remained statistically significant when women with diet controlled GDM (n=216) were examined separately (11% vs 27%, P=0.02). Induction during the 39th week continued to be associated with a reduced risk of cesarean after adjusting for differences between each group; aOR 0.4 (95% CI 0.2-0.8) for all women with GDM and aOR 0.3 (95% CI 0.1-0.8) for women with diet-controlled GDM. CONCLUSION: For women with GDM, labor induction at 39 weeks is associated with a lower rate of cesarean delivery than expectant management.

Delivery or expectant management for prevention of adverse maternal and neonatal outcomes in hypertensive disorders of pregnancy: an individual participant data meta-analysis.

ABSTRACTObjectiveHypertensive disorders affect 3–10% of pregnancies. Delayed delivery carries maternal risks, while early delivery increases fetal risk, so appropriate timing is important. The aim of this study was to compare immediate delivery with expectant management for prevention of adverse maternal and neonatal outcomes in women with hypertensive disease in pregnancy.MethodsCENTRAL, PubMed, MEDLINE and ClinicalTrials.gov were searched for randomized controlled trials comparing immediate delivery to expectant management in women presenting with gestational hypertension or pre‐eclampsia without severe features from 34 weeks of gestation. The primary neonatal outcome was respiratory distress syndrome (RDS) and the primary maternal outcome was a composite of HELLP syndrome and eclampsia. The PRISMA‐IPD guideline was followed and a two‐stage meta‐analysis approach was used. Relative risks (RR) and numbers needed to treat or harm (NNT/NNH) with 95% CI were calculated to evaluate the effect of the intervention.ResultsMain outcomes were available for 1724 eligible women. Compared with expectant management, immediate delivery reduced the composite risk of HELLP syndrome and eclampsia in all women (0.8% vs 2.8%; RR, 0.33 (95% CI, 0.15–0.73); I 2 = 0%; NNT, 51 (95% CI, 31.1–139.3)) as well as in the pre‐eclampsia subgroup (1.1% vs 3.5%; RR, 0.39 (95% CI, 0.15–0.98); I 2 = 0%). Immediate delivery increased RDS risk (3.4% vs 1.6%; RR, 1.94 (95% CI 1.05–3.6); I 2 = 24%; NNH, 58 (95% CI, 31.1–363.1)), but depended upon gestational age. Immediate delivery in the 35th week of gestation increased RDS risk (5.1% vs 0.6%; RR, 5.5 (95% CI, 1.0–29.6); I 2 = 0%), but immediate delivery in the 36th week did not (1.5% vs 0.4%; RR, 3.4 (95% CI, 0.4–30.3); I 2 not applicable).ConclusionIn women with hypertension in pregnancy, immediate delivery reduces the risk of maternal complications, whilst the effect on the neonate depends on gestational age. Specifically, women with a‐priori higher risk of progression to HELLP, such as those already presenting with pre‐eclampsia instead of gestational hypertension, were shown to benefit from earlier delivery. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

Perinatal Outcomes Following Prolonged Preterm Premature Rupture of Membranes before Limit of Viability - A Single Center Experience

Objective: To investigate maternal and neonatal outcomes following prolonged preterm premature rupture of membrane (PPROM) before limit of viability in a single center. Methods: Thirty-two women with PPROM before 25 weeks'' gestation without overt intrauterine infection were administered expectant management. We investigated maternal and neonatal outcomes of pregnancies following PPROM occurring before 25 weeks’ gestation and with latent period (from membrane rupture to delivery) of 7 days or more. Results: Median gestational age at membrane rupture was 22.1 weeks. Median latent period was 32 days. Median gestational age at delivery was 26.6 weeks. The incidence of clinical pulmonary hypoplasia and early onset sepsis was 43.5% (10/23) and 21.7% (5/23), respectively. The overall mortality in neonatal intensive care unit (NICU) was 43.5% (10/23). Latent period was negatively correlated with gestational age at membrane rupture (r=-0.501, P=0.015), but not associated with maternal complications. As the length of latent period increased, overall mortality in NICU decreased (relative risk=0.898, P=0.011). Conclusion: The expectant management in women with PPROM before 25 weeks'' gestation did not induce maternal complications and might help to improve the neonatal outcomes rather than the immediate delivery.

How does planned early birth compare with expectant management for women with prelabor rupture of membranes at term and for their children?

How does planned early birth compare with expectant management for women with prelabor rupture of membranes at term and for their children?

The randomised uterine septum transsection trial (TRUST): design and protocol

BackgroundA septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus.Methods/designA multi-centre randomised controlled trial comparing hysteroscopic septum resection and expectant management in women with recurrent miscarriage or subfertility and diagnosed with a septate uterus. The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage and complications following hysteroscopic septum resection. The analysis will be performed according to the intention to treat principle. Kaplan-Meier curves will be constructed, estimating the cumulative probability of conception leading to live birth rate over time. Based on retrospective studies, we anticipate an improvement of the live birth rate from 35% without surgery to 70% with surgery. To demonstrate this difference, 68 women need to be randomised.DiscussionHysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus. Solid evidence for this recommendation is lacking and data from randomised trials is urgently needed.Trial registrationDutch trial registry (NTR1676, 18th of February 2009).

263. Neonatal developmental and behavioral outcomes of immediate delivery versus expectant management in hypertensive disorders of pregnancy: 2-year outcomes of the HYPITAT II trial

Background In the management of hypertensive disorders(HD) in preterm pregnancy, maternal benefits of delivery need to be weighed against the neonatal consequences of preterm birth. We report 2-year child outcomes of the HYPITAT-II trial, which compared delivery versus expectant management(EM) in these women. Objective To compare effects of delivery versus EM in women with hypertension in late preterm pregnancy on neurodevelopmental and behavioral outcomes in their offspring at two years of age. Study design We studied children born in the HYPITAT-II trial, in which 704 women with a HD between 34 and 37 weeks of gestation were randomized to immediate delivery or EM. Participating women were asked to complete the Ages and Stages Questionnaire (ASQ) for developmental outcome and the Child Behavior Checklist (CBCL) for behavioral problems when their toddler was two years old. Outcomes were dichotomized and analyzed by logistic regression analysis. Results We approached 545 (77%) randomized women, of whom 344 (64%) participated. In the delivery group, 45/162 (28%) infants had an abnormal ASQ-score compared to 27/148 (18%) in the EM group (difference in percentage 9.6, CI 0.3 to 18.0); p = 0.045. An abnormal CBCL outcome was found in 31/175 (18%) in the delivery group versus 24/166 (15%) in the EM group (difference in percentage 3.2 (CI − 4.6 to 11.0). After correction for maternal education, management strategy remained an independent predictor of abnormal ASQ-score (OR 0.48, CI 0.24 −0.96, p = 0.03). In multivariable analyses, birth weight, maternal education and management policy were all significantly associated with an abnormal ASQ-score. Conclusions This study suggests that early delivery in women with late preterm HD results in poorer neurodevelopmental outcome at two years of age, indicating an increased risk of developmental delay compared to EM. This should be considered in the timing of delivery in women with a late preterm HD.

Cost-Effectiveness of Curettage Versus Expectant Management in Women With an Incomplete Evacuation After Misoprostol Treatment for First-Trimester Miscarriage: A Randomized Controlled Trial and Cohort Study

(Abstracted from Acta Obstet Gynecol Scand 2018;97(3):294–300) Misoprostol was introduced over 10 years ago as a treatment option for women with first-trimester miscarriages alongside expectant management and curettage. It is an effective treatment for 50% to 85% of these women.

Cost-effectiveness of curettage vs. expectant management in women with an incomplete evacuation after misoprostol treatment for first-trimester miscarriage: a randomized controlled trial and cohort study.

Curettage is more effective than expectant management in women with suspected incomplete evacuation after misoprostol treatment for first-trimester miscarriage. The cost-effectiveness of curettage vs. expectant management in this group is unknown. From June 2012 until July 2014 we conducted a randomized controlled trial and parallel cohort study in the Netherlands, comparing curettage with expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment for first-trimester miscarriage. Successful treatment was defined as a sonographic finding of an empty uterus 6 weeks after study entry, or an uneventful course. Cost-effectiveness and cost-utility analyses were performed. We included costs of healthcare utilization, informal care and lost productivity. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated using bootstrapping. We included 256 women from 27 hospitals; 95 curettage and 161 expectant management. Treatment was successful in 96% of the women treated with curettage vs. 83% of the women after expectant management (mean difference 13%, 95% confidence interval 5-20). Mean costs were significantly higher in the curettage group (mean difference €1157; 95% C confidence interval €955-1388). The incremental cost-effectiveness ratio for curettage vs. expectant management was €8586 per successfully treated woman. The cost-effectiveness acceptability curve showed that at a willingness-to-pay of €18 200/extra successfully treated women, the probability that curettage is cost-effective is 95%. Curettage is not cost-effective compared with expectant management in women with an incomplete evacuation of the uterus after misoprostol treatment. This indicates that curettage in this group should be restrained.

Misoprostol treatment vs expectant management in women with early non‐viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial

To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization. This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 μg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days. Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group. In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Excerpts from the World Medical Literature.

Summary: A multicentre cohort study was conducted alongside an RCT to evaluate the effectiveness of curettage versus expectant management in women with incomplete evacuation of the uterus (as judged by ultrasound) after misoprostol treatment for first trimester miscarriage. The primary end point was an empty uterus on ultrasound at 6 weeks or uneventful clinical follow-up; secondary end points included need for antibiotics, blood loss >500 mL, and need for other surgical re-intervention. There was a small statistically significant benefit in the immediate curettage group (95% vs. 85% successful outcome; risk ratio 1.1; 95% CI 1.03 to 1.2) with a higher but non-significant increase in complication rate (6.2% vs. 2.3%; risk ratio 2.7; 95% CI 0.6 to 12). Expectant management is an effective and safe option for the majority of such patients.

Cesarean Section Rates and Adverse Neonatal Outcomes After Induction of Labour Versus Expectant Management in Women With an Unripe Cervix: A Secondary Analysis of the HYPITAT and DIGITAT Trials

(BJOG. 2016;123(9):1501–1508) Between 20% and 25% of pregnancies involve induction of labor (IOL), with the intervention indicated when conditions exist where a better outcome for mother and/or child would be expected if the pregnancy is not further prolonged. However, the effectiveness of IOL is debatable, especially in the setting of an unripe cervix, with studies indicating an associated high rate of cesarean section (CS). The objective of this study was to evaluate CS and adverse neonatal outcome rates for IOL versus expectant management in women with an unripe cervix at or near term, using a secondary analysis of data from 2 previously completed randomized trials.