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1.
Clín. investig. ginecol. obstet. (Ed. impr.) ; 51(2): [100934], Abri-Jun, 2024. ilus, tab
Artículo en Español | IBECS | ID: ibc-232730

RESUMEN

Antecedentes: La pérdida gestacional precoz acontece en el 10-20% de todas las gestaciones clínicas, siendo el 85% previos a la semana 12 de amenorrea. El aborto involuntario conlleva una carga muy significativa en los recursos destinados a sanidad, alcanzado un coste económico nacional en Reino Unido de 471 millones de libras esterlinas por año (533,06 millones de euros), cifra extrapolable a otros países industrializados. Según una revisión sistemática reciente no hay ensayos bien diseñados en gestaciones del primer trimestre que arrojen una evidencia consolidada sobre cuál es el mejor método de tratamiento de aborto del primer trimestre y existen diferentes estudios que han tratado de evidenciar reducción de costes con resultados contradictorios. Material y métodos: Se realiza un estudio de diseño observacional, retrospectivo y longitudinal. Se revisaron 892 pacientes diagnosticadas de aborto espontáneo durante el primer trimestre de gestación, en el periodo comprendido entre enero de 2013 y diciembre de 2016. En nuestro estudio hemos querido evaluar la efectividad del misoprostol vaginal como tratamiento médico para el aborto espontáneo en el primer trimestre, en comparación con el legrado obstétrico/evacuador y, cuantificar la diferencia en los costos de ambos procedimientos a través de un estudio de minimización de costes. Resultados: De las 892 pacientes reclutadas, se realizó tratamiento médico con misoprostol en 517 (57,95%) y tratamiento quirúrgico mediante legrado evacuador en 375 (42,05%). La efectividad del tratamiento médico fue del 82% (426/517). Con respecto al tratamiento quirúrgico la efectividad resultó del 100%. La tasa de éxito del tratamiento médico fue superior en el subgrupo de pacientes con aborto incompleto (92,9%), en comparación con los grupos de gestación anembrionada (85,7%) y aborto diferido (78,2%). Conclusiones: El tratamiento médico del aborto es un manejo seguro y aceptado por las pacientes...(AU)


Background: Early pregnancy loss occurs in 10-20% of all clinical pregnancies, 85% being prior to week 12 of amenorrhea. Miscarriage entails a very significant burden on healthcare resources, reaching a national economic cost in the United Kingdom of £471 million per year (€533.06 million), a figure that can be extrapolated to other industrialized countries. According to a recent systematic review, there are no well-designed trials in first-trimester pregnancies that provide consolidated evidence on what is the best first-trimester abortion treatment method, and there are different studies that have tried to demonstrate cost reduction with contradictory results. Material and methods: An observational, retrospective and longitudinal design study was carried out. 892 patients diagnosed with spontaneous abortion during the first trimester of pregnancy were reviewed, in the period between January 2013 and December 2016. In our study, we wanted to evaluate the efficacy of vaginal misoprostol as a medical treatment for spontaneous abortion in the first trimester, in comparison with obstetric curettage-evacuator, and to quantify the difference in the costs of both procedures through a cost minimization study. costs. Results: Of the 892 recruited patients, medical treatment with misoprostol was performed in 517 (57.95%) and surgical treatment by curettage in 375 (42.05%). The effectiveness of medical treatment was 82% (426/517). With respect to surgical treatment the effectiveness of 100%. The success rate of medical treatment was higher in the subgroup of patients with incomplete abortion (92.9%), compared to the anembryonic gestation (85.7%) and delayed abortion (78.2%) groups. Conclusions: The medical treatment of abortion is a safe management and accepted by the patients. The adequate selection of candidate patients leads to an increase in the success rate and a decrease in costs...(AU)


Asunto(s)
Humanos , Femenino , Aborto Espontáneo/tratamiento farmacológico , Resultado del Tratamiento , Misoprostol/economía , Costos de los Medicamentos , Aborto , Estudios Retrospectivos , Estudios Longitudinales
2.
Biomol Biomed ; 24(1): 153-158, 2024 01 03.
Artículo en Inglés | MEDLINE | ID: mdl-37597215

RESUMEN

The aim of this study was to investigate the clinical efficacy of combining pelvic floor neuromuscular stimulation treatment (NMES) with sodium hyaluronate in preventing intrauterine adhesions (IUA) following abortion. A total of 140 women who underwent artificial abortion were enrolled. The control group received only an intrauterine injection of sodium hyaluronate post-surgery, while the observation group received both the injection and daily pelvic floor NMES treatments, beginning on the day after the abortion. Monthly follow-ups on menstrual conditions were conducted for six months post-surgery. Fasting venous blood samples from both groups were collected on the second day post-abortion and the day after treatment. Transvaginal color Doppler ultrasound was used on the second day post-abortion and the 15th day post the first menstrual cycle to measure endometrial thickness, and the pulsatility and resistance indices of the endometrial spiral arteries. Over the six-month follow-up, the combination therapy group exhibited a notably lower IUA incidence compared to the control group (2.8% vs. 15.7%). Furthermore, combined treatment significantly expedited post-abortion menstrual recovery, reduced vaginal bleeding volume and duration (P < 0.001). It also increased endometrial thickness and reduced the endometrial spiral artery's pulsatility and resistance indices (P < 0.05). In addition, lower serum tumor necrosis factor alpha (TNF-α) and higher interleukin-10 (IL-10) were found in the observation group compared to the control group (P < 0.05). The combination therapy offers significant advantages in preventing and reducing IUA after abortion, resulting in a substantial reduction in IUA occurrence.


Asunto(s)
Aborto Inducido , Aborto Espontáneo , Enfermedades Uterinas , Embarazo , Femenino , Humanos , Ácido Hialurónico/farmacología , Diafragma Pélvico/diagnóstico por imagen , Enfermedades Uterinas/tratamiento farmacológico , Aborto Inducido/efectos adversos , Aborto Espontáneo/tratamiento farmacológico , Estimulación Eléctrica/efectos adversos
3.
J Am Pharm Assoc (2003) ; 64(1): 245-252.e1, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37913990

RESUMEN

BACKGROUND: Mifepristone, followed by misoprostol, is commonly used for medication abortion and early miscarriage care. Since mifepristone's approval in 2000, the Food and Drug Administration (FDA) has placed restrictions on where and how it could be dispensed, including applying a Risk Evaluation and Mitigation Strategy in 2011. In December 2021, the FDA removed the in-person dispensing requirement and, in January 2023, began allowing certified pharmacies to dispense the drug directly to patients. OBJECTIVES: To explore pharmacist knowledge about misoprostol and mifepristone, experience dispensing misoprostol, as well as comfort and readiness to dispense mifepristone should federal regulations allow. METHODS: We conducted in-depth interviews with 21 U.S.-based pharmacists and pharmacy trainees between June and December of 2021, a time when few pharmacists were allowed to dispense mifepristone. RESULTS: Participants reported varied knowledge about medications for miscarriage and abortion but described themselves as generally knowledgeable about medications and reported strategies for learning about new medications. Most said they would feel ready to dispense mifepristone, and many described dispensing misoprostol without difficulty. Potential challenges specific to mifepristone dispensing included employer hesitation and colleague refusals. To assure successful dispensing, participants recommended basic training and fact sheets; relationships with prescribers for follow-up; and policies for prescription transfers in the event of refusal. CONCLUSIONS: We found that nearly all participants would feel ready to dispense mifepristone with some basic training. Pharmacists self-report having the skills and resources to learn about new medications quickly. Our findings support the FDA's rule change allowing pharmacist dispensing of mifepristone and suggest that most challenges would stem from individual or institutional refusals.


Asunto(s)
Aborto Inducido , Aborto Espontáneo , Misoprostol , Embarazo , Femenino , Humanos , Mifepristona , Farmacéuticos , Aborto Espontáneo/tratamiento farmacológico
4.
Transfus Clin Biol ; 31(1): 41-47, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38007217

RESUMEN

This article summarizes the current situation of anti-D immunoglobulin (anti-D-Ig) use in RhD-negative pregnant women at home and abroad. The article describes the concept, research and development history, and domestic and foreign applications of anti-D-Ig and points out that anti-D-Ig has not been widely used in China, mainly due to reasons such as unavailability in the domestic market and non-standard current application strategies. The article focuses on analyzing the genetic and immunological characteristics of RhD-negative populations in China. The main manifestations were that the total number of hemolytic disease of the newborn (HDN) relatively high and D variant type. In particular, there are more Asian-type DEL, the importance of clinical application of anti-D-Ig was pointed out, and its antibody-mediated immunosuppressive mechanism was analyzed, which mainly includes red blood cell clearance, epitope blocking/steric hindrance, and Fc γ R Ⅱ B receptor mediated B cell inhibition, anti-D-Ig glycosylation, etc.; clarify the testing strategies of RhD blood group that should be adopted in response to the negative initial screening of pregnant and postpartum women; this article elaborates on the necessity of using anti-D-Ig in RhD-negative mothers after miscarriage or miscarriage, as well as the limitations of its application both domestically and internationally. It also proposes a solution strategy for detecting RhD blood group incompatibility HDFN as early as possible, diagnosing it in a timely manner, and using anti-D-Ig for its prevention and treatment. If the DEL gene is defined as an Asian-type DEL, anti-D-Ig prophylaxis in women would be unnecessary. Finally, based on the specificity of RhD-negative individuals, the article looks forward to the application trend of anti-D-Ig in China. It also called for related drugs to be listed in China as soon as possible and included in medical insurance.


Asunto(s)
Aborto Espontáneo , Eritroblastosis Fetal , Recién Nacido , Femenino , Embarazo , Humanos , Mujeres Embarazadas , Sistema del Grupo Sanguíneo Rh-Hr/genética , Aborto Espontáneo/tratamiento farmacológico , Globulina Inmune rho(D)/uso terapéutico , Eritroblastosis Fetal/diagnóstico , Eritroblastosis Fetal/prevención & control , Eritroblastosis Fetal/genética
5.
Eye (Lond) ; 38(5): 951-963, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37980398

RESUMEN

INTRODUCTION: Anti-vascular endothelial growth factor (anti-VEGF) agents may occasionally need to be considered for sight-threatening macular pathology in pregnant and breastfeeding women. This is controversial due to the dearth of data on systemic side effects for mother and child. We aimed to expand the evidence base to inform management. METHODS: Retrospective case series of pregnant and breastfeeding women treated with intravitreal anti-VEGF injections at Oxford Eye Hospital between January 2015 and December 2022. In addition, we conducted a systematic review and combined eligible cases in a narrative synthesis. RESULTS: We treated six pregnant women with anti-VEGF for diabetic macular oedema(DMO) (n = 5) or choroidal neovascularisation (CNV) (n = 1). Four received ranibizumab whilst two (not known to be pregnant) received aflibercept. Patients known to be pregnant underwent counselling by an obstetric physician. Five pregnancies resulted in live births. Combining our cases with those previously published, treatment of 41 pregnant women (42 pregnancies) are reported. Indications for treatment included CNV (n = 28/41,68%), DMO (n = 7/41,17%) and proliferative diabetic retinopathy (n = 6/41,15%). Bevacizumab (n = 22/41,54%) and ranibizumab (n = 17/41,41%) were given more frequently than aflibercept (n = 2/41,5%). Many (n = 16/41,40%) were unaware of their pregnancy when treated. Most pregnancies resulted in live births (n = 34/42,81%). First trimester miscarriages (n = 5/42,12%) and stillbirths (n = 3/42,7%) mostly occurred in women with significant risk factors. CONCLUSION: Intravitreal anti-VEGF injections may not necessarily compromise obstetric outcomes, although clear associations cannot be drawn due to small numbers and confounders from high rates of first trimester miscarriages in general and inherently high-risk pregnancies. It may be worth considering routinely investigating pregnancy and breastfeeding status in women of childbearing age prior to each injection, as part of anti-VEGF treatment protocols.


Asunto(s)
Aborto Espontáneo , Neovascularización Coroidal , Retinopatía Diabética , Embarazo , Niño , Femenino , Humanos , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis/uso terapéutico , Factores de Crecimiento Endotelial/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/uso terapéutico , Aborto Espontáneo/inducido químicamente , Aborto Espontáneo/tratamiento farmacológico , Lactancia Materna , Estudios Retrospectivos , Bevacizumab/uso terapéutico , Receptores de Factores de Crecimiento Endotelial Vascular/uso terapéutico , Retinopatía Diabética/tratamiento farmacológico , Neovascularización Coroidal/tratamiento farmacológico , Inyecciones Intravítreas , Proteínas Recombinantes de Fusión/uso terapéutico
6.
Taiwan J Obstet Gynecol ; 62(5): 661-666, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37678992

RESUMEN

OBJECTIVE: To assess the clinical characteristics and endocrinological background of women with vascular retained products of conception (RPOC) after miscarriage or abortion and evaluate the effect of estrogen-progestogen therapy (EPT) as an initial treatment on this population based on their endocrinological background. MATERIALS AND METHODS: Women with vascular RPOC after miscarriage or abortion at less than 20 weeks of pregnancy who were given EPT (conjugated estrogen and norethisterone) were retrospectively reviewed. Their clinical characteristics, hormonal parameters, ultrasonographic findings, and outcomes were evaluated. RESULTS: Of 35 women with vascular RPOC, 30 (86%) presented with vaginal bleeding at a visit, and 6 (17%) required inpatient management due to heavy bleeding. Among women who presented with vaginal bleeding, serum progesterone levels were significantly lower (0.25 vs. 6.5 ng/mL, p = 0.004) than those in women who did not present with vaginal bleeding. There were no differences in serum hCG levels (10.5 vs. 3.1 mIU/mL) or serum estradiol levels (65.4 vs. 162.3 pg/mL). After withdrawal bleeding following the first course of EPT, vaginal bleeding was stopped in 27 of the 30 women (90%), and 23 (66%) of all women had a thin and linear endometrium. All women could be treated by up to two courses of EPT and did not require additional interventions. The median duration to hCG normalization after the initial EPT was 24.5 (9-88) days. CONCLUSION: Women with vascular RPOC who have no bleeding had significantly higher levels of serum progesterone, indicating that administration of progestogen may have an effect on hemostasis. Endometrial bleeding can be prevented or stopped, and retained tissues can be conservatively expelled by oral administration of EPT, including norethisterone, in women with vascular RPOC.


Asunto(s)
Aborto Espontáneo , Embarazo , Humanos , Femenino , Aborto Espontáneo/tratamiento farmacológico , Progestinas , Progesterona , Estudios Retrospectivos , Estrógenos , Noretindrona , Hemorragia Uterina/tratamiento farmacológico , Hemorragia Uterina/etiología
7.
Fertil Steril ; 120(5): 951-954, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37648141

RESUMEN

The physical and psychological impact of miscarriage can be devastating. There are many lifestyle and therapeutic interventions that may prevent a miscarriage. In this review, we have outlined the key areas for health optimization to prevent pregnancy loss, drawing on the most up-to-date evidence available. The 3 key areas identified are lifestyle optimization in women, lifestyle optimization in men, and therapeutic interventions. The evidence demonstrates that the treatments to consider are first-trimester progesterone administration, levothyroxine in women with subclinical hypothyroidism, and the combination of aspirin and heparin in women with antiphospholipid antibodies.


Asunto(s)
Aborto Habitual , Aborto Espontáneo , Hipotiroidismo , Embarazo , Femenino , Humanos , Aborto Espontáneo/etiología , Aborto Espontáneo/prevención & control , Aborto Espontáneo/tratamiento farmacológico , Aborto Habitual/prevención & control , Aspirina/uso terapéutico , Heparina/uso terapéutico , Tiroxina/uso terapéutico
8.
Arch Gynecol Obstet ; 308(5): 1543-1548, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37653249

RESUMEN

PURPOSE: This study evaluated the differences in treatment outcomes between misoprostol and surgical evacuation for the management of incomplete abortion. METHODS: This retrospective cohort study compared patients with a clinical diagnosis of incomplete abortion who underwent surgical or pharmaceutical (misoprostol) intervention, 2014-2017. Demographics, sonographic results, treatment follow-up, and post-intervention data on retained products of conception were retrieved. Women with incomplete abortion who underwent surgical versus pharmaceutical intervention were compared. RESULTS: Among 589 spontaneous abortions, 198 were included in the study, of which 123 (62.1%) underwent surgical evacuation and 75 (37.9%) pharmaceutical intervention with misoprostol. Baseline characteristics were similar between groups. During 130.8 ± 91.7 days of follow-up, no patient who underwent surgical evacuation had retained products of conception or needed surgical hysteroscopy. Four cases (5.3%) in the misoprostol group had retained products of conception and needed hysteroscopy (p = 0.02). Patients who underwent surgical evacuation had higher hemoglobin levels during follow-up (12.1 mg/dL vs. 11.7 mg/dL, p = 0.05). There were no differences in post-treatment pregnancy rates between groups. CONCLUSION: Long-term follow-up after incomplete abortion showed that hemodynamically stable patients treated with misoprostol achieved the desired results in 95% of cases without significant differences in pregnancy intervals compared to surgical management. Further prospective studies with larger sample sizes are required to confirm the outcomes described in this study.


Asunto(s)
Abortivos no Esteroideos , Aborto Incompleto , Aborto Inducido , Aborto Espontáneo , Misoprostol , Embarazo , Humanos , Femenino , Aborto Espontáneo/tratamiento farmacológico , Aborto Incompleto/tratamiento farmacológico , Aborto Incompleto/cirugía , Misoprostol/uso terapéutico , Abortivos no Esteroideos/uso terapéutico , Estudios Prospectivos , Estudios Retrospectivos , Preparaciones Farmacéuticas
9.
JAMA ; 330(8): 766-3, 2023 08 22.
Artículo en Inglés | MEDLINE | ID: mdl-37477929

RESUMEN

This study assesses the use of mifepristone plus misoprostol for miscarriage management among commercially insured adults in the US.


Asunto(s)
Abortivos no Esteroideos , Aborto Espontáneo , Mifepristona , Femenino , Humanos , Embarazo , Abortivos no Esteroideos/uso terapéutico , Aborto Espontáneo/tratamiento farmacológico , Mifepristona/uso terapéutico , Misoprostol
10.
J Eur Acad Dermatol Venereol ; 37(10): 1971-1990, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37262303

RESUMEN

Biologicals have transformed the management of severe disease phenotypes in psoriasis and are often prescribed in women of childbearing age. However, information on safety of biologicals in pregnancy are lacking. We conducted a systematic review and meta-analysis aimed to describe the characteristics and pregnancy outcomes in women with psoriasis exposed to biologics within 3 months before or during pregnancy, and to estimate the pooled prevalence of spontaneous, elective and total abortions, and congenital malformations in their newborns. Bibliographic searches were performed in the PubMed, Embase, Scopus and Web of Science databases up to 14 April 2022. No restrictions on sample size or publication date were applied. Review performance complied with PRISMA guidelines, and two reviewers assessed randomized controlled trials and nonrandomized studies reporting pregnancy outcomes in women exposed to biologics indicated for psoriasis during the pre-gestational and/or gestational period. Studies focusing on rheumatologic or gastroenterological immune-mediated inflammatory diseases were excluded. Regardless of data heterogeneity, a random-effects model was used to pool prevalence estimates. We included 51 observational studies, involving 739 pregnancies exposed to approved biologics for psoriasis. Administration was mostly (70.4%) limited to the first trimester, and the most common drug was ustekinumab (36.0%). The estimated prevalence of miscarriage was 15.3% (95% confidence interval [CI] 12.7-18.0) and elective abortions, 10.8% (95% CI 7.7-14.3). Congenital malformations occurred in about 3.0% (95% CI 1.6-4.8) of live births exposed to biologics during pregnancy. Altogether, exposure to biologics for psoriasis during pregnancy and/or conception does not seem to be associated with an increased risk of miscarriage/abortion or congenital malformations, showing similar rates to the general population. These results suggest that biologic drugs are safe and pose an acceptable risk to the foetuses/neonates.


Asunto(s)
Aborto Espontáneo , Productos Biológicos , Psoriasis , Recién Nacido , Embarazo , Humanos , Femenino , Aborto Espontáneo/inducido químicamente , Aborto Espontáneo/epidemiología , Aborto Espontáneo/tratamiento farmacológico , Psoriasis/tratamiento farmacológico , Psoriasis/inducido químicamente , Ustekinumab/uso terapéutico , Resultado del Embarazo , Productos Biológicos/efectos adversos , Terapia Biológica
13.
Fertil Steril ; 119(6): 954-963, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36781098

RESUMEN

IMPORTANCE: Over the last decade, frozen embryo transfer (FET) has been increasingly used in contemporary fertility units. Despite the rapid increase in FET, there is still insufficient evidence to recommend an optimized protocol for endometrial preparation especially in patients with lower progesterone (P4) levels. Previous studies have concluded that P4 levels <10 ng/mL are associated with poorer pregnancy outcomes than those reported with high levels of circulating P4. OBJECTIVE: To identify whether rescue P4 dosing in patients with low P4 can salvage adverse outcomes associated with low P4 levels, resulting in outcomes comparable to patients with adequate progesterone. DATA SOURCES: The study was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-analyses guidelines and prospectively registered under the PROSPERO database (CRD42022357125). Six databases (Embase, MEDLINE, APA PsycInfo, Global Health, HMIC Health Management Information Consortium, and Google Scholar) and 2 additional sources were searched from inception to August 29, 2022. STUDY SELECTION AND SYNTHESIS: Prospective and retrospective cohort studies, reporting the association between rescue progesterone and one or more pregnancy outcomes, were included. The quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS), while the quality of evidence by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. Summative and subgroup data as well as heterogeneity were generated by the Cochrane platform RevMan (V. 5.4). MAIN OUTCOME MEASURE(S): To compare ongoing pregnancy rate as primary outcome and clinical pregnancy rate, miscarriage rate, and live birth rate as secondary outcomes between patients with low (<10 ng/mL) receiving rescue progesterone vs. those with adequate levels of P4 (≥10 ng/mL). RESULT(S): Overall, 7 observational studies were included in the analysis, with a total of 5927 patients of median age 34 (interquartile range [IQR]: 31.55, 37.13). Overall, patient group comparison, namely those with low P4 that received a rescue dose and those with adequate P4 levels, did not yield significant differences for either the primary or secondary outcomes. For ongoing clinical pregnancy, patients with low P4 receiving the rescue dose vs. those with adequate P4 levels was odds ratio (OR) 0.98 (95% CI: 0.78, 1.24; P = .86, I2: 41%), whereas for miscarriage events, OR was 0.98 (95% CI: 0.81, 1.17; P = .80, I2: 0). Equally, for clinical pregnancy, OR was 0.91 (95% CI: 0.78, 1.06; P = .24; I2: 33%), and for live birth, OR was 0.92 (95% CI: 0.77, 1.09; P = .33; I2: 43%). Subgroup analysis on the basis or rescue administration route successfully explained summative heterogeneity. CONCLUSION(S): Rescue P4 dosing in patients with low P4 results in ongoing pregnancy rate, clinical pregnancy and live birth rates were comparable to those of patients with adequate P4 levels. However, robust randomized controlled trials assessing rescue treatment in women with low P4 are needed to confirm these findings. Rescue P4 in patients with low circulating P4 around embryo transfer day may result in reproductive outcomes comparable to those with adequate P4 levels. STUDY REGISTRATION: CRD42022357125 (PROSPERO).


Asunto(s)
Aborto Espontáneo , Progesterona , Embarazo , Humanos , Femenino , Adulto , Aborto Espontáneo/tratamiento farmacológico , Estudios Prospectivos , Estudios Retrospectivos , Transferencia de Embrión/métodos , Índice de Embarazo , Nacimiento Vivo
14.
Hum Reprod ; 38(4): 560-568, 2023 04 03.
Artículo en Inglés | MEDLINE | ID: mdl-36806843

RESUMEN

STUDY QUESTION: In women with threatened miscarriage, does progesterone supplementation until the completion of the first trimester of pregnancy increase the probability of live birth? SUMMARY ANSWER: In women with threatened miscarriage, 400 mg vaginal progesterone nightly, from onset of bleeding until 12 weeks, did not increase live birth rates. WHAT IS KNOWN ALREADY: Limited evidence has indicated that vaginal micronized progesterone may make little or no difference to the live birth rate when compared with placebo in women with threatened miscarriage. Subgroup analysis of one recent randomized trial reported that in women with bleeding and at least one previous miscarriage, progesterone might be of benefit. STUDY DESIGN, SIZE, DURATION: We performed a randomized, double-blinded, placebo-controlled trial between February 2012 and April 2019. Eligible pregnant women under 10 weeks gestation, experiencing a threatened miscarriage as apparent from vaginal bleeding were randomized into two groups in a 1:1 ratio: the intervention group received 400 mg progesterone as vaginal pessaries, the control group received placebo vaginal pessaries, both until 12 weeks gestation. The primary endpoint was live birth. We planned to randomize 386 women (193 per group). The study was stopped at a planned interim analysis for futility after randomization of 278 women. PARTICIPANTS/MATERIALS, SETTING, METHODS: This trial was conducted at the Mater Mothers' Hospital, a tertiary centre for maternity care in South Brisbane, Queensland, Australia. We randomized 139 women to the intervention group and 139 women to the placebo group. Primary outcome data were available for 136 women in the intervention group and 133 women in the placebo group. MAIN RESULTS AND THE ROLE OF CHANCE: The live birth rates were 82.4% (112/136) and 84.2% (112/133) in the intervention group and placebo group, respectively (risk ratio (RR) 0.98, 95% CI 0.88 to 1.09; risk difference -0.02, 95% CI -0.11 to 0.07; P = 0.683). Among women with at least one previous miscarriage, live birth rates were 80.6% (54/67) and 84.4% (65/77) (RR 0.95, 95% CI 0.82-1.11; P = 0.550). No significant effect was seen from progesterone in women with two (RR 1.28, 95% CI 0.96-1.72; P = 0.096) or more (RR 0.79, 95% CI 0.53-1.19; P = 0.267) previous miscarriages. Preterm birth rates were 12.9% and 9.3%, respectively (RR 1.38; 95% CI 0.69 to 2.78; P = 0.361). Median birth weight was 3310 vs 3300 g (P = 0.992). There were also no other significant differences in obstetric and perinatal outcomes. LIMITATIONS, REASONS FOR CAUTION: Our study was single centre and did not reach the planned sample size because it was stopped prematurely at an interim analysis. WIDER IMPLICATIONS OF THE FINDINGS: We did not find evidence supporting the treatment effect of vaginal progesterone in women with threatened miscarriage. Progesterone in this setting should not be routinely used for threatened miscarriage. The treatment effect in women with threatened miscarriage after previous miscarriages warrants further research. STUDY FUNDING/COMPETING INTEREST(S): Mothers' and babies Golden Casket Clinical Fellowship (L.A.M.). Progesterone and placebo pessaries were provided by Perrigo Australia.B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. TRIAL REGISTRATION NUMBER: ACTRN12611000405910. TRIAL REGISTRATION DATE: 19 April 2011. DATE OF FIRST PATIENT'S ENROLMENT: 06 February 2012.


Asunto(s)
Aborto Espontáneo , Amenaza de Aborto , Servicios de Salud Materna , Nacimiento Prematuro , Embarazo , Femenino , Recién Nacido , Humanos , Progesterona/uso terapéutico , Aborto Espontáneo/epidemiología , Aborto Espontáneo/tratamiento farmacológico , Amenaza de Aborto/tratamiento farmacológico , Nacimiento Prematuro/prevención & control , Índice de Embarazo
15.
Am J Reprod Immunol ; 89(3): e13669, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36524676

RESUMEN

OBJECTIVE: To investigate the reproductive outcomes by comparing two kinds of antibiotic schemes for chronic endometritis (CE) in infertile women's fresh embryo transfer (FET) cycles and identify subgroups of patients with CE who need long-term antibiotics treatment. DESIGN: A retrospective cohort study. SETTING: University-based reproductive medical center. PATIENT(S): A total of 492 women with CD138-positive plasmacytes per 10 high-power fields (CD138+/10HPF). INTERVENTION(S): Hysteroscopy was performed and endometrial biopsy samples were collected in the proliferative phase. Long-term or short-term antibiotics were administrated. After antibiotics treatment, patients underwent in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) and received ET. MAIN OUTCOME MEASURE(S): Ongoing pregnancy rate, clinical pregnancy rate, clinical miscarriage rate. RESULT (S): There were no significant differences in pregnancy outcomes between patients with CD138+/10HPF 1-4 (low-grade CE) who received long-term antibiotic therapy and short-term antibiotics groups. Among women with CD138+/10HPF ≥5 (high-grade CE), live birth rate (48.4% vs. 14.7%, p = .001), clinical pregnancy rate (66.7% vs. 35.3%, p = .002) and ongoing pregnancy rate (59.1% vs. 20.6%, p < .001) in the long-term arm were significantly higher than that in the short-term arm. The clinical miscarriage rate (21.0% vs. 58.3%, p = .013) was statistically lower in the long-term antibiotics group, but no statistical differences were found between the two groups in preterm delivery rate. CONCLUSION: Long-term antibiotics treatment was a sensible choice to improve pregnancy outcomes in women with CD138+/10HPF ≥5 (high-grade CE). The pregnancy outcomes of women with low-grade CE only defined by histological diagnosis were not greatly improved after antibiotic therapy. Therefore, we recommended the proper diagnosis criteria were CD138+/10HPF ≥5 pathologically.


Asunto(s)
Aborto Espontáneo , Endometritis , Infertilidad Femenina , Masculino , Embarazo , Recién Nacido , Humanos , Femenino , Endometritis/diagnóstico , Aborto Espontáneo/tratamiento farmacológico , Infertilidad Femenina/tratamiento farmacológico , Infertilidad Femenina/patología , Estudios Retrospectivos , Semen , Resultado del Embarazo , Transferencia de Embrión , Índice de Embarazo , Enfermedad Crónica , Fertilización In Vitro , Antibacterianos/uso terapéutico
17.
BMJ Sex Reprod Health ; 49(2): 97-104, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36351785

RESUMEN

INTRODUCTION: Abortion providers may be reluctant to commence abortion before ultrasound evidence of intrauterine pregnancy (IUP) due to concerns of missed ectopic pregnancy. In 2017, very early medical abortion (VEMA) was introduced at an abortion service in Edinburgh, UK. Following ultrasound, patients without confirmed IUP, and without symptoms or risk factors for ectopic pregnancy, could commence treatment immediately after baseline serum-human chorionic gonadotrophin (hCG) measurement, and return for follow-up serum-hCG a week later to determine treatment success (≥80% decline from baseline). This study aimed to compare clinical outcomes between two pathways: (1) VEMA; and (2) standard-of-care delayed treatment where treatment is only commenced on IUP confirmation by serial serum-hCG monitoring and/or repeat ultrasound. METHODS: A retrospective database review was conducted of VEMA eligible patients from July 2017 to December 2021. Study groups were determined by patient preference. Records were searched for abortion outcomes, duration of care, number of appointments (clinic visits, ultrasounds, serum-hCG) and clinical data entries. RESULTS: Of 181 patients included, 77 (43%) chose VEMA and 104 (57%) chose delayed treatment. 11/181 (6.1%) were lost to follow-up. Cohort ectopic prevalence was 4.4% and was not statistically different between groups (2.6% vs 5.8%, VEMA vs delayed group, respectively, p=0.305), as with complete abortion rates (93.3% vs 97.6%, p=0.256). All VEMA group ectopics were detected on the seventh day (from initial visit) while time-to-diagnosis for delayed group ectopics ranged from 7 days to 3 weeks. VEMA patients had significantly reduced duration of care (12 vs 21 days, p<0.001), number of visits (2 vs 3, p<0.001), ultrasounds (1 vs 2, p<0.001) and data entries (6 vs 9, p<0.001). CONCLUSIONS: VEMA is safe, effective and reduces the duration of care, number of appointments and clinical administrative time. It should be offered to medically eligible patients.


Asunto(s)
Aborto Inducido , Aborto Espontáneo , Misoprostol , Embarazo Ectópico , Embarazo , Femenino , Humanos , Mifepristona/uso terapéutico , Estudios Retrospectivos , Embarazo Ectópico/inducido químicamente , Embarazo Ectópico/tratamiento farmacológico , Aborto Espontáneo/tratamiento farmacológico
18.
Arch Gynecol Obstet ; 307(4): 1073-1081, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36525092

RESUMEN

RESEARCH QUESTION: Does antioestrogen effect of clomiphene citrate (CC) on the endometrium reduce implantation and thereby decrease pregnancy and live birth rate per transferred embryo? METHODS: In this cohort, unstimulated IVF cycles modified with clomiphene citrate (CC-NC-IVF) and unstimulated, natural IVF cycles (NC-IVF) conducted between 2011 and 2016 were included. CC was applied in a dosage of 25mcg per day, starting on cycle day 7 until ovulation trigger day. Primary outcomes were clinical pregnancy rate, defined as amniotic sac visible in ultrasound, and live birth rate per transferred embryo. Miscarriage rate calculated as amniotic sac not ending in a live birth was secondary outcome. A modified mixed-effect Poisson regression model was applied, and adjustments were made for female age, parity, type and cause of infertility. Additionally, stratification by parity and age was performed. RESULTS: Four hundred and ninety-nine couples underwent a total of 1042 IVF cycles, 453 being NC-IVF and 589 being CC-NC-IVF cycles. Baseline characteristics of both groups did not differ. Addition of CC did neither decrease clinical pregnancy rate (aRR 0.86; 95% CI 0.67-1.12) nor live birth rate per transferred embryo (aRR 0.84; 95% CI 0.62-1.13) in comparison with NC-IVF. Miscarriage rate did not differ between CC-NC-IVF and NC-IVF (aRR 0.95; 95% CI 0.57-1.57). CONCLUSION: Low-dose CC does not reduce pregnancy or live birth rate per transferred embryo. It can be used in infertility treatment without negatively affecting the endometrium and implantation.


Asunto(s)
Aborto Espontáneo , Infertilidad , Embarazo , Femenino , Humanos , Tasa de Natalidad , Fertilización In Vitro , Aborto Espontáneo/epidemiología , Aborto Espontáneo/tratamiento farmacológico , Estudios Retrospectivos , Clomifeno/uso terapéutico , Índice de Embarazo , Infertilidad/tratamiento farmacológico , Nacimiento Vivo , Inducción de la Ovulación
19.
J Assist Reprod Genet ; 39(12): 2729-2736, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36378460

RESUMEN

PURPOSE: To analyze outcomes of pulsatile administration of gonadotropin-releasing hormone (GnRH) in infertile women diagnosed with functional hypothalamic amenorrhea (FHA). METHODS: A single-center retrospective cohort study was conducted from 1996 to 2020. Sixty-six patients with the diagnosis FHA that underwent therapy using the pulsatile GnRH pump for conception were included and analyzed. The primary outcome was the live birth rate (LBR). Secondary outcomes were the number of dominant follicles, ovulation rate, biochemical pregnancy rate (BPR), clinical pregnancy rate (CPR), miscarriage rate, and multiple pregnancy rate. A matched control group was selected to compare the birth weight of newborn children. RESULTS: During the study period, 66 patients with FHA underwent 82 treatments (14 of 66 patients had more than one treatment) and a total of 212 cycles (ovulation induction attempts) using pulsatile GnRH. The LBR per treatment was 65.9%. The ovulation rate per cycle was 96%, and monofollicular ovulation was observed in 75% of cycles. The BPR per treatment was 80.5%, and the cumulative CPR per treatment was 74.4%. The miscarriage rate was 11.5%. One dizygotic twin pregnancy was observed (1.6%). Average newborn birth weight (NBW) from patients with FHA was comparable to the control group. CONCLUSION(S): In patients with FHA, excellent pregnancy rates were achieved using the subcutaneous GnRH pump. The high cumulative LBR with normal NBW as well as low rates of multiple gestation indicate that the pulsatile GnRH pump represents a safer and more physiologic alternative to ovulation induction with injectable gonadotropins. TRIAL REGISTRATION: Ethics Committee Northwest and Central Switzerland (Ethikkommission Nordwest- und Zentralschweiz - EKNZ) - Project-ID 2020-01612.


Asunto(s)
Aborto Espontáneo , Infertilidad Femenina , Embarazo , Femenino , Recién Nacido , Humanos , Hormona Liberadora de Gonadotropina , Amenorrea/tratamiento farmacológico , Amenorrea/epidemiología , Infertilidad Femenina/tratamiento farmacológico , Tasa de Natalidad , Estudios Retrospectivos , Aborto Espontáneo/tratamiento farmacológico , Peso al Nacer , Inducción de la Ovulación/métodos , Ovulación
20.
Arch Razi Inst ; 77(1): 199-204, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-35891743

RESUMEN

Pregnancy termination for a variety of fetal or maternal conditions has been defined as one of the common obstetrical procedures. The presence of an earlier uterine scar has been found as a highly significant risk factor, which needs to be considered before the election of the misoprostol for the termination of pregnancy (TOP) uses. This study aimed to evaluate the safety of vaginal misoprostol in patients who had an earlier uterine scar, and whether its utilization might result in increasing the risks of uterine ruptures. In total, 250 participants were included in the experimental model and divided into two groups including 95 patients in their 2nd trimester of pregnancy with confirmed non-viable fetus and scarred uterus (study group) and 155 pregnant women with no scar in their uterus and missed miscarriage (control group). They received misoprostol tablets in accordance with the Security Hospital Protocol for the TOP. The safety has been specified according to the number of women that had full abortions with no complications. The study group with uterine scar included 95 cases that comprised 38% of the total participants in the study (n=250). Out of 95 cases, 64 (67.3%) patients had successful abortions completely, compared to the control group (the patients with no scar), 111 (71.6%) of whom had complete abortions (P<0.001). However, 44 (28.4%) and 31 (32.6%) patients in the control and study groups, respectively, were in need of surgical evacuations either for the incomplete conception product expulsion or as a result of the excessive per-vaginal bleeding. The use of the misoprostol for the TOP has not been contra-indicated in the females who had Caesarean scars. Moreover, it is efficient in females who do not have scarred uterus.


Asunto(s)
Abortivos no Esteroideos , Aborto Espontáneo , Misoprostol , Abortivos no Esteroideos/uso terapéutico , Aborto Espontáneo/tratamiento farmacológico , Estudios de Casos y Controles , Cicatriz , Femenino , Humanos , Irak , Misoprostol/efectos adversos , Embarazo , Segundo Trimestre del Embarazo , Útero/patología
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