Dataset Information

Predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.

ABSTRACT:

Purpose

To identify predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.

Methods

This was a planned secondary analysis of data from a published randomized controlled trial comparing expectant management with vaginal single dose of 800 µg misoprostol treatment of women with embryonic or anembryonic miscarriage. Predefined variables-serum-progesterone, serum-β-human chorionic gonadotropin, parity, previous vaginal deliveries, gestational age, clinical symptoms (bleeding and pain), mean diameter and shape of the gestational sac, crown-rump-length, type of miscarriage, and presence of blood flow in the intervillous space-were tested as predictors of treatment success (no gestational sac in the uterine cavity and maximum anterior-posterior intracavitary diameter was ≤ 15 mm as measured with transvaginal ultrasound on a sagittal view) in univariable and multivariable logistic regression.

Results

Variables from 174 women (83 expectant management versus 91 misoprostol) were analyzed for prediction of complete miscarriage at ≤ 17 days. In patients managed expectantly, the rate of complete miscarriage was 62.7% (32/51) in embryonic miscarriages versus 37.5% (12/32) in anembryonic miscarriages (P = 0.02). In multivariable logistic regression, the likelihood of success increased with increasing gestational age, increasing crown-rump-length and decreasing gestational sac diameter. Misoprostol treatment was successful in 80.0% (73/91). No variable predicted success of misoprostol treatment.

Conclusions

Complete miscarriage after expectant management is significantly more likely in embryonic miscarriage than in anembryonic miscarriage. Gestational age, crown-rump-length, and gestational sac diameter are independent predictors of success of expectant management. Predictors of treatment success may help counselling women with early miscarriage.

SUBMITTER: Fernlund A

PROVIDER: S-EPMC7524815 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.

Fernlund Anna A Jokubkiene Ligita L Sladkevicius Povilas P Valentin Lil L

Archives of gynecology and obstetrics 20200707 5

<h4>Purpose</h4>To identify predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.<h4>Methods</h4>This was a planned secondary analysis of data from a published randomized controlled trial comparing expectant management with vaginal single dose of 800 µg misoprostol treatment of women with embryonic or anembryonic miscarriage. Predefined variables-serum-progesterone, serum-β-human chorionic gonadotropin ...[more]

PMID: 32638095

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Project description:BackgroundAlthough nausea and vaginal bleeding are commonly experienced in early pregnancy, their prognostic value in predicting clinical pregnancy loss is not well understood.ObjectiveThis study aimed to understand whether timing of bleeding and nausea symptoms can be used to predict risk of pregnancy loss among women with ultrasound-confirmed pregnancies.Study designA cohort of 701 women with clinically confirmed pregnancies and 1 to 2 previous pregnancy losses were preconceptionally enrolled in the Effects of Aspirin in Gestation and Reproduction trial (2006-2012). Participants completed daily symptom diaries from 2 to 8 weeks' gestation and were prospectively monitored for detection of pregnancy loss. The risk of pregnancy loss was estimated for each observed bleeding and nausea pattern, and positive and negative predictive values for each pattern were calculated.ResultsAmong 701 women, 211 (30.1%) reported any vaginal bleeding, and 639 (91.2%) reported any nausea. Most bleeding experienced by women was spotting and contained within a single episode. Within 2 to <4, 4 to <6, and 6 to 8 weeks' gestation, vaginal bleeding occurred in 5.9% (41) (5.7% live birth, 7.1% clinical pregnancy loss), 14.6% (102) (13.9% live birth, 18.6% clinical pregnancy loss), and 20.8% (146) (18.4% live birth, 32.4% clinical pregnancy loss) of women, respectively. Within the same gestational periods, nausea was reported in 22.7% (159) (23.2% live birth, 20.4% clinical pregnancy loss), 65.9% (462) (67.5% live birth, 58.4% clinical pregnancy loss), and 87.0% (610) (90.6% live birth, 69.0% clinical pregnancy loss) of women. Women who had bleeding without nausea between 6 and 8 weeks' gestation (3.6% prevalance) had the greatest risk of clinical pregnancy loss (risk difference=56.1%; 95% confidence interval, 37.6-74.7), a positive predictive value of 68.0% (49.7%, 86.3%), negative predictive value of 85.8% (83.2%, 88.4%), positive likelihood ratio of 11.1 (2.04, 20.1), and negative likelihood ratio of 0.86 (0.79, 0.93). Nausea and bleeding are clinical factors that predicted clinical pregnancy loss (area under the curve, 0.87; 95% confidence interval, 0.81-0.88) similar to age, body mass index, blood pressure, and waist-to-hip ratio (area under the curve, 0.81; 95% confidence interval, 0.78-0.88) measured preconceptionally.ConclusionWomen experiencing bleeding without nausea between 6 and 8 weeks' gestation had an increased risk of clinical pregnancy loss. Bleeding and nausea were not predictive risk factors of clinical pregnancy loss prior to 6 weeks' gestation.

Project description:ObjectiveTo ascertain whether a clinically important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage.DesignRandomised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage.SettingEarly pregnancy assessment units of seven hospitals in the United Kingdom.ParticipantsWomen of less than 13 weeks' gestation, with a diagnosis of early fetal demise or incomplete miscarriage.InterventionsExpectant management (no specific intervention); medical management (vaginal dose of misoprostol preceded, for women with early fetal demise, by oral mifepristone 24-48 hours earlier); surgical management (surgical evacuation).Main outcome measuresConfirmed gynaecological infection at 14 days and eight weeks; need for unplanned admission or surgical intervention.Results1200 women were recruited: 399 to expectant management, 398 to medical management, and 403 to surgical management. No differences were found in the incidence of confirmed infection within 14 days between the expectant group (3%) and the surgical group (3%) (risk difference 0.2%, 95% confidence interval - 2.2% to 2.7%) or between the medical group (2%) and the surgical group (0.7%, - 1.6% to 3.1%). Compared with the surgical group, the number of unplanned hospital admissions was significantly higher in both the expectant group (risk difference - 41%, - 47% to - 36%) and the medical group (- 10%, - 15% to - 6%). Similarly, when compared with the surgical group, the number of women who had an unplanned surgical curettage was significantly higher in the expectant group (risk difference - 39%, - 44% to - 34%) and the medical group (- 30%, - 35% to - 25%).ConclusionsThe incidence of gynaecological infection after surgical, expectant, and medical management of first trimester miscarriage is low (2-3%), and no evidence exists of a difference by the method of management. However, significantly more unplanned admissions and unplanned surgical curettage occurred after expectant management and medical management than after surgical management. TRIAL REGISTRATION NATIONAL RESEARCH REGISTER: N0467011677/N0467073587.

Project description:ImportanceMedication management of early pregnancy loss (EPL), or miscarriage, typically involves the administration of misoprostol with or without pretreatment with mifepristone. Combination treatment with mifepristone plus misoprostol is more effective than misoprostol alone but is underutilized in the US.ObjectiveTo describe differences in clinical outcomes after EPL management with mifepristone plus misoprostol vs misoprostol alone using commercial claims data.Design, setting, and participantsThis retrospective cohort study used national insurance claims data from the IBM MarketScan Research Database. Participants included pregnant people (aged 15-49 years) with private insurance who presented with an initial EPL diagnosis between October 1, 2015, and December 31, 2022.ExposuresThe primary exposure was the medication used to manage EPL (ie, mifepristone plus misoprostol or misoprostol alone). Other exposures of interest included demographic characteristics and location of service.Main outcomes and measuresThe primary outcome was subsequent procedural management (eg, uterine aspiration) after EPL diagnosis and medication management. Other outcomes of interest included return visits, hospitalizations, and complications occurring in the subsequent 6 weeks. Descriptive statistics and bivariate analyses were used, and a multivariable logistic regression model was created to examine factors associated with subsequent procedural management.ResultsThis study included 31 977 patients (mean [SD] age, 32.7 [5.6] years) with claims for EPL who received medication management. Of these patients, 3.0% received mifepristone plus misoprostol and 97.0% received misoprostol alone. Patients who received misoprostol with pretreatment with mifepristone were less likely to have subsequent uterine aspiration (10.5% vs 14.0%; P = .002), and they were also less likely to have subsequent emergency department (ED) visits for EPL (3.5% vs 7.9%; P < .001). In multivariable analysis, use of mifepristone plus misoprostol was associated with decreased odds of subsequent procedural management (adjusted odds ratio, 0.71 [95% CI, 0.57-0.87]).Conclusions and relevanceThe findings of this study suggest that mifepristone is underutilized for the medication management of EPL, but its use is associated with a lower need for subsequent uterine aspiration and a decrease in the number of subsequent visits to an ED. Increasing access to mifepristone for EPL management may decrease health care utilization and expenditures.

Project description:BackgroundThe anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.MethodsMifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.FindingsBetween Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.InterpretationTreatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.FundingUK National Institute for Health Research Health Technology Assessment Programme.

Dataset Information

Predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.

Purpose

Methods

Results

Conclusions

Publications

Predictors of complete miscarriage after expectant management or misoprostol treatment of non-viable early pregnancy in women with vaginal bleeding.

Similar Datasets

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