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

Fernlund, A.; Jokubkiene, L.; Sladkevicius, Povilas; Valentin, Lil

doi:10.1002/uog.18940

Cited by 18 publications

(40 citation statements)

References 44 publications

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“…This is a planned secondary analysis of prospectively collected data in a published randomized controlled trial comparing expectant management with vaginal single dose 800 µg misoprostol treatment of embryonic and anembryonic first-trimester miscarriage [6] (ClinicalTrials.gov ID: NCT01033903). The regional ethical review board, Lund University, Sweden, approved the trial (Dnr 83/2008), which was carried out in accordance with the code of ethics of the Declaration of Helsinki.…”

Section: Methodsmentioning

confidence: 99%

“…Early miscarriage occurs in 10-15% of clinically recognized pregnancies [1][2][3]. Expectant or medical management are alternatives to surgical evacuation [4][5][6]. Randomized trials comparing medical treatment, most often misoprostol, with expectant management or placebo show substantial variation in success rates defined as complete miscarriage without surgical intervention [4][5][6][7][8][9][10].…”

Section: Introductionmentioning

confidence: 99%

“…Expectant or medical management are alternatives to surgical evacuation [4][5][6]. Randomized trials comparing medical treatment, most often misoprostol, with expectant management or placebo show substantial variation in success rates defined as complete miscarriage without surgical intervention [4][5][6][7][8][9][10]. The discrepancies are explained by differences in types of miscarriage included, symptomatology, definition of complete miscarriage and treatment success, and dose regimens of drugs.…”

Section: Introductionmentioning

confidence: 99%

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

Fernlund

Jokubkiene

Sladkevicius

et al. 2020

Arch Gynecol Obstet

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Fernlund

Jokubkiene

Sladkevicius

et al. 2020

Arch Gynecol Obstet

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“…11,12 Our estimates of miscarriage treatment-related events, including the more than 6% retained products of conception, are in the range of other estimates. [24][25][26][27][28][29][30][31] The rates of miscarriage treatment-related events are notably higher than published rates of abortion-related events. 9,10,12,32,33 One explanation is that there have been both government sponsored and professional association sponsored clinical quality improvement initiatives for abortion for more than 40 years, [33][34][35] meaning that considerable attention has been brought to ensuring and improving the safety of abortion care.…”

Section: Commentmentioning

confidence: 99%

“…There were more events after medication treatment in office-based settings than hospitals and ASCs, although still within the range of published estimates. [24][25][26][27][28][29][30][31] As medication treatment does not involve procedures performed in facilities, these findings may reflect how other aspects of care, such as patient education, follow-up, and treatments provided at follow-up, may vary across facility types.…”

Section: Commentmentioning

confidence: 99%

Miscarriage Treatment–Related Morbidities and Adverse Events in Hospitals, Ambulatory Surgery Centers, and Office-Based Settings

et al. 2018

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Objective: To examine whether miscarriage treatment-related morbidities and adverse events vary across facility types. Methods: A retrospective cohort study compared miscarriage treatmentrelated morbidities and adverse events across hospitals, ambulatory surgery centers (ASCs), and office-based settings. Data on women who had miscarriage treatment between 2011-2014 and were continuously enrolled in their insurance plan for at least one year prior to and at least six weeks after treatment were obtained from a large national private insurance claims database. The main outcome was miscarriage treatment-related morbidities and adverse events occurring within six-weeks of miscarriage treatment. Secondary outcomes were major events and infections. Results: 97,374 miscarriage treatments met inclusion criteria. Most (75%) were provided in hospitals, 10% ASCs, and 15% office-based settings. 9.3% had miscarriage treatment-related events, 1.0% major events, and 1.5% infections. In adjusted analyses, there were fewer events in ASCs (6.5%) than office-based settings (9.4%) and hospitals (9.6%), but no significant difference between office-based settings and hospitals. There were no significant differences in major events between ASCs (0.7%) and office-based settings (0.8%), but more in hospitals (1.1%) than ASCs and office-based settings. There were fewer infections in ASCs (0.9%) than office-based settings (1.2%) and more in hospitals (1.6%) than ASCs and office-based settings. In analyses stratified by miscarriage treatment type, the difference 45 46 3 between ASCs and office-based settings was no longer significant for miscarriages treated with procedures. Conclusions: While there appear to be slightly more events in hospitals than ASCs or office-based settings, findings do not support limiting miscarriage treatment to particular settings.

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Medical treatment for early fetal death (less than 24 weeks)

Lemmers

Verschoor

Kim

et al. 2019

Cochrane Database of Systematic Reviews

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

Abstract: ABSTRACT

Cited by 18 publications

References 44 publications

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

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

Miscarriage Treatment–Related Morbidities and Adverse Events in Hospitals, Ambulatory Surgery Centers, and Office-Based Settings

Medical treatment for early fetal death (less than 24 weeks)

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