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1.
Trop Med Int Health ; 25(6): 714-722, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32155681

RESUMO

OBJECTIVE: To characterise the occurrence of fever (≥38.0°C) after treatment for post-partum haemorrhage (PPH) with sublingual misoprostol 800 mcg in Latin America, where elevated rates of misoprostol's thermoregulatory effects and recipients' increased susceptibility to high fever have been documented. METHODS: A prospective observational study in hospitals in Argentina enrolled consenting women with atonic PPH after vaginal delivery, eligible to receive misoprostol. Corporal temperature was assessed at 30, 60, 90 and 120 min post-treatment; other effects were recorded. The incidence of high fever ≥ 40.0°C (primary outcome) was compared to the rate observed previously in Ecuador. Logistic regressions were performed to identify clinical and population-based predictors of misoprostol-induced fever. RESULTS: Transient shivering and fever were experienced by 75.5% (37/49) of treated participants and described as acceptable by three-quarters of women interviewed (35/47). The high fever rate was 12.2% (6/49), [95% Confidence Interval (CI) 4.6, 24.8], compared to Ecuador's rate following misoprostol treatment (35.6% (58/163) [95% CI 28.3, 43.5], P = 0.002). Significant predictors of misoprostol-induced fever (model dependent) were as follows: pre-delivery haemoglobin < 11.0g/dl, rapid placental expulsion, and higher age of the woman. No serious outcomes were reported prior to discharge. CONCLUSIONS: Misoprostol to treat PPH in Argentina resulted in a significantly lower rate of high fever than in Ecuador, although both are notably higher than rates seen elsewhere. A greater understanding of misoprostol's side effects and factors involved in their occurrence, including genetics, will help alleviate concerns. The onset of shivering may be the simplest way to know if fever can also be expected.


Assuntos
Febre/induzido quimicamente , Misoprostol/efeitos adversos , Hemorragia Pós-Parto/tratamento farmacológico , Administração Sublingual , Adolescente , Adulto , Argentina/epidemiologia , Grupos de Populações Continentais , Equador/epidemiologia , Feminino , Humanos , Incidência , Misoprostol/administração & dosagem , Estudos Prospectivos , Fatores Socioeconômicos , Adulto Jovem
2.
Am J Public Health ; 110(5): 677-684, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32191521

RESUMO

In the aftermath of the introduction of severe restrictions on abortion in several US states, some activists have argued that providing widespread access to an abortive drug, misoprostol, will transform an induced abortion into a fully private act and therefore will empower women. In Brazil, where abortion is criminalized, the majority of women who wish to terminate an unwanted pregnancy already use the illegal, but easily accessible, misoprostol. We examine the history of misoprostol as an abortifacient in Brazil from the late 1980s until today and the professional debates on the teratogenicity of this drug. The effects of a given pharmaceutical compound, we argue, are always articulated, elicited, and informed within dense networks of sociocultural, economic, legal, and political settings. In a conservative and repressive environment, the use of misoprostol for self-induced abortions, even when supported by formal or informal solidarity networks, is far from being a satisfactory solution to the curbing of women's reproductive rights.


Assuntos
Abortivos/uso terapêutico , Aborto Induzido/legislação & jurisprudência , Aborto Induzido/métodos , Empoderamento , Misoprostol/uso terapêutico , Abortivos/administração & dosagem , Abortivos/efeitos adversos , Aborto Induzido/psicologia , Brasil , Características Culturais , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Política , Direitos Sexuais e Reprodutivos , Direitos da Mulher
3.
PLoS One ; 15(1): e0227245, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31923193

RESUMO

OBJECTIVE: To compare effectiveness and safety of oral misoprostol (50 µg every four hours as needed), low dose vaginal misoprostol (25 to 50 µg every six hours as needed), and our established dinoprostone vaginal gel (one to two mg every six hours as needed) induction. MATERIALS AND METHODS: Consenting women with a live term single cephalic fetus for indicated labor induction were randomized (3N = 511). Prior uterine surgery or non-reassuring fetal surveillance were exclusions. Concealed computer generated randomization was stratified and blocked. Newborns were assessed by a team unaware of group assignment. The primary outcome was time from induction at randomization to vaginal birth for initial parametric analysis. Sample size was based on mean difference of 240 minutes with α2 = 0.05 and power 95%. Non-parametric analysis was also pre-specified ranking cesareans as longest vaginal births. RESULTS: Enrollment was from April 1999 to December 2000. Demographics were similar across groups. Analysis was by intent to treat, with no loss to follow up. Mean time (±SD) to vaginal birth was 1356 (±1033) minutes for oral misoprostol, 1530 (±3249) minutes for vaginal misoprostol, and 1208 (±613) minutes for vaginal dinoprostone (P = 0.46, ANOVA). Median times to vaginal birth were 1571, 1339, and 1451 minutes respectively (P = 0.46, Kruskal-Wallis). Vaginal births occurred within 24 hours in 44.9, 53.5 and 47.7% respectively (P = 0.27, χ2). There were no significant differences in Kaplan Meier survival analyses, cesareans, adverse effects, or maternal satisfaction. The newborn who met birth asphyxia criteria received vaginal misoprostol, as did. all three other newborns with cord artery pH<7.0 (P = 0.04, Fisher Exact). CONCLUSION: There was no significant difference in effectiveness of the three groups. Profound newborn acidemia, though infrequent, occurred only with low dose vaginal misoprostol.


Assuntos
Dinoprostona/administração & dosagem , Dinoprostona/farmacologia , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Misoprostol/farmacologia , Ocitócicos/administração & dosagem , Ocitócicos/farmacologia , Administração Intravaginal , Administração Oral , Adulto , Dinoprostona/efeitos adversos , Feminino , Humanos , Recém-Nascido , Misoprostol/efeitos adversos , Ocitócicos/efeitos adversos , Satisfação do Paciente , Gravidez , Resultado do Tratamento , Adulto Jovem
4.
Neuro Endocrinol Lett ; 40(3): 152-158, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31816221

RESUMO

INTRODUCTION: The study aimed to detect factors predicting a successful pharmacological induction of first-trimester miscarriage. MATERIAL AND METHODS: A prospective, cohort research was conducted at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, between years 2011-2015. 642 women diagnosed with first trimester miscarriage qualified for pharmacological induction with misoprostol were included in the study. Each patient underwent repeatable doses of 800mcg misoprostol vaginally. The endpoint was complete excretion of all tissues, with no need to perform surgical curettage. Type of miscarriage, gravidity, parity, number of doses, time of drug administration and side effects were analysed as possible factors influencing the results. The statistical analysis was performed with STATISTICA 10.0 software. RESULTS: The percentage of successful miscarriage induction was 83.6%. Two main factors corresponded with successful pharmacological treatment in regression analysis: number of administered doses (adjusted OR 1.64; 95% CI 1.18-2.29) and week of gestation (aOR 1.22; 95%CI 1.03-1.44). The success of the pharmacological induction of miscarriage was significantly decreased if the woman had a history of caesarean section (aOR 0.34; 95% CI 0.2-0.57). 2.2% of patients experienced benign side effects of the therapy. CONCLUSIONS: Pharmacological induction is an effective and safe treatment method of first trimester abortion in the majority of cases. The knowledge of factors influencing the efficacy of misoprostol may help clinicians in proper counselling and individualisation of therapy.


Assuntos
Aborto Espontâneo/tratamento farmacológico , Misoprostol/uso terapêutico , Primeiro Trimestre da Gravidez , Adulto , Estudos de Coortes , Relação Dose-Resposta a Droga , Feminino , Humanos , Misoprostol/efeitos adversos , Paridade , Gravidez , Primeiro Trimestre da Gravidez/efeitos dos fármacos , Estudos Prospectivos , História Reprodutiva , Resultado do Tratamento
5.
BMC Pregnancy Childbirth ; 19(1): 443, 2019 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-31775677

RESUMO

BACKGROUND: Early pregnancy failure (EPF) is a common complication of pregnancy. If women do not abort spontaneously, they will undergo medical or surgical treatment in order to remove the products of conception from the uterus. Curettage, although highly effective, is associated with a risk of complications; medical treatment with misoprostol is a safe and less expensive alternative. Unfortunately, after 1 week of expectant management in case of EPF, medical treatment with misoprostol has a complete evacuation rate of approximately 50%. Misoprostol treatment results may be improved by pre-treatment with mifepristone; its effectiveness has already been proven for other indications of pregnancy termination. This study will test the hypothesis that, in EPF, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). METHODS: The trial will be performed multi-centred, prospectively, two-armed, randomised, double-blinded and placebo-controlled. Women with confirmed EPF by ultrasonography (6-14 weeks), managed expectantly for at least 1 week, can be included and randomised to pre-treatment with oral mifepristone (600 mg) or oral placebo (identical in appearance). Randomisation will take place after receiving written consent to participate. In both arms pre-treatment will be followed by oral misoprostol, which will start 36-48 h later consisting of two doses 400 µg (4 hrs apart), repeated after 24 h if no tissue is lost. Four hundred sixty-four women will be randomised in a 1:1 ratio, stratified by centre. Ultrasonography 2 weeks after treatment will determine short term treatment effect. When the gestational sac is expulsed, expectant management is advised until 6 weeks after treatment when the definitive primary endpoint, complete or incomplete evacuation, will be determined. A sonographic endometrial thickness < 15 mm using only the allocated therapy by randomisation is considered as successful treatment. Secondary outcome measures (patient satisfaction, complications, side effects and costs) will be registered using a case report form, patient diary and validated questionnaires (Short Form 36, EuroQol-VAS, Client Satisfaction Questionnaire, iMTA Productivity Cost Questionnaire). DISCUSSION: This trial will answer the question if, in case of EPF, after at least 1 week of expectant management, sequential treatment with mifepristone and misoprostol is more effective than misoprostol alone to achieve complete evacuation of the products of conception. TRIAL REGISTRATION: Clinicaltrials.gov (d.d. 02-07-2017): NCT03212352. Trialregister.nl (d.d. 03-07-2017): NTR6550. EudraCT number (d.d. 07-08-2017): 2017-002694-19. File number Commisie Mensgebonden Onderzoek (d.d. 07-08-2017): NL 62449.091.17.


Assuntos
Abortivos não Esteroides/uso terapêutico , Abortivos Esteroides/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Incompleto/diagnóstico por imagem , Adolescente , Adulto , Análise Custo-Benefício , Método Duplo-Cego , Quimioterapia Combinada/efeitos adversos , Feminino , Humanos , Mifepristona/administração & dosagem , Misoprostol/efeitos adversos , Estudos Multicêntricos como Assunto , Satisfação do Paciente , Gravidez , Primeiro Trimestre da Gravidez , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ultrassonografia , Conduta Expectante , Adulto Jovem
6.
PLoS One ; 14(11): e0215718, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31751343

RESUMO

BACKGROUND: The metabolic activity of endogenous nitric oxide (NO) and the medical use of nitrovasodilatory drugs like isosorbide dinitrate have been shown to be potential inducers inducers of cervical ripening prior to surgical evacuation of the uterus. OBJECTIVE: To assess the therapeutic efficacy and safety of combined isosorbide dinitrate-oxytocin in the management of intrauterine foetal death (IUFD). METHODS: Sixty women with IUFD after 20 weeks of gestation requesting uterine evacuation were randomly selected to receive isosorbide dinitrate gel solution (80 mg/1.5 mL; n = 30) or misoprostol gel solution (100 mcg/1.5 mL; n = 30) every 3 h with a maximum of four doses or until a Bishop score >7 was reached. Subsequently, patients received a high dose of intravenous oxytocin until complete uterus evacuation was achieved. Therapeutic efficacy was evaluated by mean the relative risk of the foetal expulsion based on comparison of event rates, and the proportion of women induced to labor at 7, 10 and 15 h after the administration of isosorbide dinitrate or misoprostol. Safety was assessed on the basis of woman´s vital signs and evaluation of adverse effects, including headache, abdominal pain, pelvic pain, lower back pain, nausea, dizziness and vomiting. RESULTS: The foetal expulsion rate using the isosorbide dinitrate-oxytocin combination was approximately 4.4 times, and at least 2.1 times, the foetal expulsion rate with the misoprostol-oxytocin regimen at any given point in time. The proportion of women achieved vaginal delivery at 15 hours was 100% for the isosorbide dinitrate-oxytocin group and 86.7% for the misoprostol-oxytocin group. The average delivery induction interval was significantly lower when isosorbide dinitrate-oxytocin was used (8.7 ± 3.1 h) than when misoprostol-oxytocin (11.9 ± 3.1 h) was used. A total of 20% of patients in the isosorbide dinitrate-oxytocin group recorded headache, and no cases of uterine tachysystole, haemorrhage or coagulopathy were recorded. CONCLUSION: This study indicates that intravaginal isosorbide dinitrate followed by intravenous oxytocin was more effective than the conventional method used to induce labour in the medical management of foetal death in pregnancies after 20 weeks of gestation. TRIAL REGISTRATION: Clinicaltrials.gov NCT02488642.


Assuntos
Maturidade Cervical/efeitos dos fármacos , Morte Fetal , Dinitrato de Isossorbida/administração & dosagem , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitocina/administração & dosagem , Administração Intravaginal , Adulto , Parto Obstétrico , Método Duplo-Cego , Feminino , Humanos , Infusões Intravenosas , Dinitrato de Isossorbida/efeitos adversos , Misoprostol/efeitos adversos , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Ocitocina/efeitos adversos , Gravidez , Estudos Prospectivos , Fatores de Tempo , Adulto Jovem
7.
Medicine (Baltimore) ; 98(40): e17396, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31577749

RESUMO

Oral mifepristone combined with rivanol lactate (rivanol) is commonly used in second-trimester pregnancy termination. However, rivanol is not suitable to premature rupture of membranes and oligohydramnios because amniocentesis is difficult. Mifepristone combined with misoprostol is suitable for the patients with oligohydramnios. In accordance with the misoprostol dosing recommendations by the International Federation of Gynecology and Obstetrics (FIGO), the incidences of uterine rupture and cervical laceration are relatively high in Chinese pregnant women. The aim of our study was to optimize misoprostol dosing regimen in terms of efficacy and safety in Chinese pregnant women.We modified the Bishop Score, and then gave patients low-dose misoprostol according to the modified Bishop score. Based on the amniotic fluid volume (AFV) indicated by type-B ultrasonic instrument, the cases with AFV ≤2 cm receiving low-dose misoprostol combined with mifepristone and the cases with amniocentesis failure followed by receiving low-dose misoprostol combined with mifepristone were enrolled into study group, and the cases with AFV >2 cm receiving rivanol combined with mifepristone were enrolled into control group. The start time of uterine contractions, time of fetal expulsion, birth process, hospital day, successful induced labor rate, complete induced labor rate, and incomplete induced labor rate were observed and compared between the 2 groups.There were significant differences in the start time of uterine contractions, time of fetal expulsion, birth process, and hospital day between the control group and the study group (all P < .05). The successful induced labor rate, complete induced labor rate, and incomplete induced labor rate were also significantly different between the 2 groups (all P < .05).In the induced labor of 16 to 28 weeks pathological pregnancy, low-dose misoprostol can markedly improve the successful induced labor rate and complete induced labor rate, shorten the birth process and hospital day, and decrease uterine curettage rate and uterine rupture risk. Low-dose misoprostol combined with mifepristone is suitable to the induced labor of 16 to 28 weeks pathological pregnancy in Chinese women.


Assuntos
Abortivos não Esteroides/uso terapêutico , Aborto Induzido/métodos , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Complicações na Gravidez/terapia , Segundo Trimestre da Gravidez , Abortivos não Esteroides/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Aborto Induzido/efeitos adversos , Adulto , Grupo com Ancestrais do Continente Asiático , China , Relação Dose-Resposta a Droga , Quimioterapia Combinada , Feminino , Humanos , Mifepristona/administração & dosagem , Mifepristona/efeitos adversos , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Oligo-Hidrâmnio/terapia , Gravidez , Fatores de Tempo , Ruptura Uterina/prevenção & controle
8.
J Ayub Med Coll Abbottabad ; 31(3): 407-410, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31535516

RESUMO

BACKGROUND: Oligohydramnios, defined as an amniotic fluid index (AFI) of less than the 5th percentile (at term ≤5 cm, or at per-term ≤8.0 cm), has an incidence of 8.5-15.5%. It is associated with an increased perinatal morbidity and mortality. The objective of this study was to explore whether induction with misoprostol can safely be offered to patients with reduced amniotic fluid index and that vaginal delivery can be achieved without major adverse effects. METHODS: All women at term who gave consent to be part of the study and required labour induction were recruited. Total 120 women were included in study. They had a per-induction ultrasound to calculate amniotic fluid index (AFI). Based on AFI., the patients were divided into two groups: group 1, had AFI ≤5 cm and was oligohydramnios group. The other was group 2 with normal amniotic fluid, i.e., AFI >5 cm. Both these groups then underwent labour induction with misoprostol (cytotec-Pfizer) 50microgram. The dose was repeated 6 hourly for a maximum of three doses. The outcomes studied were number of tablets used, induction to labour interval, induction to the delivery interval and method of delivery. The foetal outcomes were meconium staining, Apgar score, NICU admission and advance neonatal resuscitation. RESULTS: In maternal parameters, it was observed that there was a significant difference in induction to delivery interval only and in foetal parameters it was observed that in group 1, there was statistical significance in meconium staining, Apgar score and NICU admission. CONCLUSIONS: Induction with misoprostol and vaginal delivery can safely be offered to women with oligohydramnios at term.


Assuntos
Trabalho de Parto Induzido , Misoprostol , Oligo-Hidrâmnio/epidemiologia , Ocitócicos , Resultado da Gravidez/epidemiologia , Feminino , Humanos , Trabalho de Parto Induzido/efeitos adversos , Trabalho de Parto Induzido/métodos , Misoprostol/efeitos adversos , Misoprostol/uso terapêutico , Ocitócicos/efeitos adversos , Ocitócicos/uso terapêutico , Gravidez
9.
Contraception ; 100(6): 451-456, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31491379

RESUMO

OBJECTIVES: To evaluate the safety, acceptability and feasibility of a one-day outpatient medication abortion service at gestations 13-18 weeks. STUDY DESIGN: Open-label prospective study in which participants received mifepristone 200 mg orally to swallow at home or at the clinic followed 24 h later by misoprostol 400 mcg buccally. They presented to the outpatient clinic 24-48 h after mifepristone for misoprostol 400 mcg buccally every three hours (no maximum dose). The primary outcome was successful abortion without transfer to overnight inpatient care. Secondary outcomes included time to abortion from initial misoprostol dose, safety, additional interventions and side effects. RESULTS: We enrolled 230 women from December 2017 to November 2018. Approximately nine of ten (n = 206, 89.6%) achieved a successful abortion without transfer to overnight care. Twenty-four were transferred to overnight inpatient care; of these 18 were to manage a complication, five for incomplete abortion and two by choice. Among these 24, three women experienced an SAE. The median time to successful abortion from time of the first misoprostol dose was 7.2 h (range: 0.75-92.3), with an average of three misoprostol doses. Most participants expelled the fetus and the placenta at or around the same time; median time between fetal and placental expulsion was 15 minutes (range: 0-4.5 h). Fifteen participants (6.6%) received more than five misoprostol doses and were transferred to inpatient care. Administration of more than five doses of misoprostol was associated with nulliparity. Provision of antibiotics (27.9%, n = 64), manual removal of placenta (15.3%, n = 35), uterotonics (4.4%, n = 10) and surgical interventions (4.4%, n = 10) were also reported. About one in four participants experienced nausea, vomiting and chills; fever was infrequent (2.5%, n = 5). CONCLUSIONS: For gestations 13-18 weeks, an outpatient day process for medication abortion is safe, effective and feasible. IMPLICATIONS: Medication abortion in 13 - 18 weeks need not be limited to inpatient care; nine of ten cases can be managed as an outpatient day service.


Assuntos
Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Induzido/estatística & dados numéricos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Abortivos Esteroides/efeitos adversos , Aborto Induzido/efeitos adversos , Aborto Induzido/métodos , Aborto Induzido/enfermagem , Adolescente , Adulto , Assistência Ambulatorial , Estudos de Viabilidade , Feminino , Idade Gestacional , Humanos , Pessoa de Meia-Idade , Mifepristona/efeitos adversos , Misoprostol/efeitos adversos , Nepal , Gravidez , Primeiro Trimestre da Gravidez , Segundo Trimestre da Gravidez , Estudos Prospectivos , Adulto Jovem
10.
Contraception ; 100(6): 445-450, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31520608

RESUMO

OBJECTIVES: To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20 weeks gestation and to compare side effects of buccal and vaginal misoprostol administration. STUDY DESIGN: We randomized women undergoing D&E at 14 weeks 0 days-19 weeks 6 days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2 × 2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6 h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps. RESULTS: We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8 min. with and without hygroscopic dilators (difference 3.2 minutes, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) min longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7 mm with and without hygroscopic dilators (difference 3.9 mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p = 0.04. CONCLUSIONS: Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6 h prior to D&E before 20 weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol. IMPLICATIONS: Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20 weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.


Assuntos
Abortivos não Esteroides/administração & dosagem , Aborto Induzido/métodos , Primeira Fase do Trabalho de Parto/efeitos dos fármacos , Misoprostol/administração & dosagem , Polímeros , Abortivos não Esteroides/efeitos adversos , Administração Bucal , Administração Intravaginal , Adolescente , Adulto , Feminino , Humanos , Misoprostol/efeitos adversos , Gravidez , Adulto Jovem
11.
J Perinat Med ; 47(7): 750-756, 2019 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-31373898

RESUMO

Objective To compare the efficacy of misoprostol vaginal insert (MVI) for labor induction using standard and adjusted criteria. Methods A single-center, comparative cohort study using a consecutive series of pregnant women ≥37/0 weeks undergoing labor induction with either standard criteria for MVI (administration for up to 24 h; MVI-24) or with adjusted criteria (MVI administration for a maximum of 10 h; MVI-10) conducted at a tertiary academic center in Germany. The primary outcomes were the time from start of induction to any delivery and cesarean delivery rate. Results A total of 138 women were included in the study, 69 in each group. The mean time from MVI administration to any delivery showed no significant difference between the MVI-24 and MVI-10 groups (954 vs. 969 min, respectively; P = 0.679). The cesarean delivery rate was proportionally lower for the MVI-10 group [39.1% (27/69) vs. 24.6% (17/69); P = 0.10]. Conclusion The time from induction to delivery with MVI was similar when using standard criteria of up to 24 h of exposure vs. adjusted criteria of up to 10 h of exposure. Although the threshold for statistical significance for cesarean section was not attained, there is nonetheless a considerable difference between the MVI-24 and MVI-10 groups.


Assuntos
Cesárea/estatística & dados numéricos , Trabalho de Parto Induzido/métodos , Misoprostol , Administração Intravaginal , Adulto , Cesárea/métodos , Estudos de Coortes , Feminino , Alemanha/epidemiologia , Humanos , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Gravidez , Resultado da Gravidez/epidemiologia , Tempo para o Tratamento , Contração Uterina/efeitos dos fármacos
12.
Contraception ; 100(6): 498-501, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31446021

RESUMO

Misoprostol is widely used for the medical management of incomplete abortion. Few serious adverse events have been reported, so it is considered a safe drug. We present a case of a 40-year-old woman in which misoprostol preceded coronary artery spasm.


Assuntos
Abortivos não Esteroides/efeitos adversos , Vasoespasmo Coronário/induzido quimicamente , Misoprostol/efeitos adversos , Adulto , Angiografia Coronária , Vasoespasmo Coronário/diagnóstico por imagem , Humanos
13.
BMC Pregnancy Childbirth ; 19(1): 257, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31331275

RESUMO

BACKGROUND: There is some evidence that suggests misoprostol may supplement the action of oxytocin in preventing post-partum haemorrhage (PPH). The primary objective of this study was to determine the effect of the administration of 600 µg misoprostol in addition to oxytocin versus oxytocin alone, on the risk of PPH among pregnant women after delivery. The secondary objectives were to determine the effects of the above combination on maternal death and blood transfusion among pregnant women after delivery; and to determine the incidence of PPH, its case fatality, and the maternal mortality ratio in our hospital. METHODS: Design and setting: Retrospective chart review of 1736 women delivering at the Regional Hospital Bamenda Cameroon, between 2015 and 2016. This was a pre versus post study following a policy change in the prevention of PPH. Exposure groups: One group received oxytocin-misoprostol (January-April 2016: period after policy change), and the second group received oxytocin-only (January-April 2015: period before policy change) after delivery. OUTCOMES: The primary outcome was PPH, and the secondary outcomes were maternal death and blood transfusion. STATISTICAL ANALYSIS: A 1:1 matching with replacement was done with the propensity score (PS). The groups were compared using PS matching with conditional logistic regression on the matched pairs as the main analysis. A sensitivity analysis was done using other PS adjustment methods and multiple regression. RESULTS: Of the 1736 women included in this study, 1238 were matched and compared. Women who received oxytocin-misoprostol were less likely to have PPH as compared to those receiving oxytocin-only (odds ratio [OR] 0.22, 95% confidence interval [CI] 0.08, 0.59, p = 0.003). This reduced odds of PPH was upheld in the different sensitivity analyses. There were no significant differences in the odds of maternal death and the use of blood transfusions between the two groups: OR 3.91, 95% CI [0.44, 35.08], p = 0.22, and OR 0.89, 95% CI [0.14-5.63], p = 0.91, respectively. Sensitivity analyses showed similar results. The incidence of PPH was 2.9% (before adding misoprostol the incidence was 4.4% and after adding misoprostol it was 1.5%), the case fatality rate of PPH was 1.96%, and the overall maternal mortality ratio in the hospital was 293 maternal deaths/100000 life births. CONCLUSION: Our evidence suggests that using 600 µg misoprostol as an add-on to oxytocin in the prevention of post-partum haemorrhage significantly reduces the odds of PPH without affecting other maternal outcomes.


Assuntos
Misoprostol , Ocitocina , Hemorragia Pós-Parto , Adulto , Transfusão de Sangue/estatística & dados numéricos , Camarões/epidemiologia , Sinergismo Farmacológico , Quimioterapia Combinada/métodos , Feminino , Humanos , Mortalidade Materna , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Ocitocina/administração & dosagem , Ocitocina/efeitos adversos , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/prevenção & controle , Gravidez , Resultado da Gravidez/epidemiologia , Estudos Retrospectivos
14.
Afr Health Sci ; 19(1): 1544-1553, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31148982

RESUMO

Backround: A retrospective (case-controlled) study was conducted with the aim of identifying the effect of the use of misoprostol on termination time in patients who did and did not undergo feticide procedures in second trimester pregnancy terminations. Methods: The sampling of the study consisted of 144 pregnant women who were diagnosed as having major fetal anomalies incompatible with life, and were recommended for termination of pregnancy. The investigation showed that feticide procedures were performed for 99 women, and feticide procedures were not performed for 45 women. Misoprostol protocol was administered for 48 hours in the termination period; whether the feticide procedure directly affected the termination duration in patients who did and did not undergo feticide was evaluated. Results: Abortion/birth was achieved in 103 (71.5%) women during the first 48 hours. There was no significant difference between the termination duration of the misoprostol protocol among the women who did and did not undergo feticide. There was no significant difference between the termination durations and fetal biometric measurements (BPD, HC) except head diameters (p=0.020 and p=0.015). Conclusions: The misoprostol protocol is shown to be effective and safe for the termination of pregnancies during the second trimester. Feticide has no affect on the duration of termination.


Assuntos
Abortivos não Esteroides/administração & dosagem , Aborto Induzido/métodos , Misoprostol/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Administração Intravaginal , Administração Oral , Adulto , Estudos de Casos e Controles , Feminino , Humanos , Misoprostol/efeitos adversos , Gravidez , Segundo Trimestre da Gravidez , Estudos Retrospectivos , Resultado do Tratamento
15.
Trials ; 20(1): 376, 2019 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-31227019

RESUMO

BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians. METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 µg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant. DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.


Assuntos
Aborto Incompleto/tratamento farmacológico , Tocologia , Misoprostol/uso terapêutico , Médicos , Feminino , Humanos , Misoprostol/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Segundo Trimestre da Gravidez , Projetos de Pesquisa
16.
Acta Obstet Gynecol Scand ; 98(10): 1268-1273, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31140585

RESUMO

INTRODUCTION: Misoprostol vaginal insert could lead to a significant reduction in the time to vaginal delivery, and an increase in the proportion of women achieving vaginal delivery, compared with dinoprostone vaginal insert. We compared the delivery outcomes of misoprostol 200 µg vaginal insert and dinoprostone 10 mg vaginal insert for induction of labor in women with an unfavorable cervix. MATERIAL AND METHODS: This is a retrospective observational study conducted on a cohort of 220 women with a Bishop score ≤4 admitted for induction of labor at a single institution. Of these, 109 (49.5%) received the misoprostol vaginal insert and 111 (50.5%) received the dinoprostone vaginal insert. The primary outcome was the vaginal delivery rate. Secondary outcomes were time from induction to vaginal delivery, time to any delivery mode, time from induction to the onset of active labor, oxytocin use, uterine tachysystole and need for tocolysis. RESULTS: The vaginal delivery rate was 88% in the misoprostol insert group, compared with 74% in the dinoprostone insert group (P < 0.007). The average time from drug administration to the beginning of labor was shorter in the misoprostol compared with the dinoprostone group (855 min vs 1740 min, P < 0.0001). Also, the average time from administration to delivery was shorter for women receiving misoprostol compared with dinoprostone (1113 min vs 2150 min, P < 0.0001). The use of misoprostol reduced the need for oxytocin compared with dinoprostone (30.2% vs 43.2%, P = 0.046). Finally, compared with dinoprostone, the misoprostol insert was associated with more uterine tachysystole (38% vs 12%, P < 0.001), but the rate of tachysystole requiring tocolysis was not significantly different between the 2 groups (51.2% vs 46.1%, P = 0.1). Multivariate analysis showed that Bishop score and method of induction, but not maternal body mass index or gestational age at induction, were independently associated with mode of delivery. CONCLUSIONS: The cesarean section rate was significantly lower in the misoprostol insert group. The use of misoprostol was also associated with reduced time to vaginal delivery and time to onset of active labor and with decreased use of oxytocin. Tachysystole was a frequent complication during induction of labor with the misoprostol insert.


Assuntos
Dinoprostona/administração & dosagem , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Administração Intravaginal , Adulto , Cesárea/estatística & dados numéricos , Dinoprostona/efeitos adversos , Feminino , Humanos , Misoprostol/efeitos adversos , Ocitócicos/efeitos adversos , Ocitocina/administração & dosagem , Gravidez , Resultado da Gravidez , Estudos Retrospectivos
17.
Contraception ; 100(3): 178-181, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31102629

RESUMO

OBJECTIVE: To evaluate outcomes with mifepristone 200 mg orally followed 24-48 h later by misoprostol 800 mcg vaginally for medical abortion at 64-70 days of gestation. STUDY DESIGN: We reviewed electronic databases and medical records for medical abortion cases at 64-70 days' gestation at British Pregnancy Advisory Service clinics in England and Wales from May 2015 through October 2016. Women selected in-office follow-up or self-evaluation of abortion outcome using a checklist along with low-sensitivity urine pregnancy testing. We excluded cases in which we could not locate records and when women did not proceed with medical abortion, did not use misoprostol following mifepristone if abortion had not occurred and did not attend a scheduled follow-up assessment. We analyzed demographic characteristics, treatment outcomes and significant adverse events. We defined treatment success as complete abortion without surgical evacuation and without continuing pregnancy. RESULTS: Of 2743 cases identified, we could not locate 40 charts and excluded 30 cases, leaving a final sample of 2673. Overall, 2538 (94.9%, 95% CI 94.1-95.8) women had a successful medical abortion. Reasons for failure included continuing pregnancy (n=90, 3.4%, 95% CI 2.7-4.1), retained nonviable pregnancy (n=2, 0.1%, 95% CI 0-0.2) and incomplete abortion (n=43, 1.6%, 95% CI 1.1-2.1). Of those with continuing pregnancies, 81 underwent a uterine aspiration and 9 opted to continue the pregnancy. Thirty-five (1.3%, 95% CI 0.9-1.7) women had significant adverse events; 16 (0.6%, 95% CI 0.3-0.9) underwent an in-hospital aspiration. Pelvic infection (n=4, 0.2%) and transfusion (n=1, 0.03%) occurred rarely. CONCLUSION: Medical abortion from 64 to 70 days with mifepristone and vaginal misoprostol is effective with a low rate of serious adverse events. IMPLICATIONS: Medical abortion between 64 and 70 days of gestation may be offered on an outpatient basis using mifepristone and vaginal misoprostol. Service provision without an in-person follow-up is feasible. Not all women with a continuing pregnancy after medical abortion treatment opt to have an aspiration procedure.


Assuntos
Abortivos/administração & dosagem , Aborto Incompleto/epidemiologia , Aborto Induzido/métodos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Abortivos/efeitos adversos , Administração Intravaginal , Administração Oral , Adolescente , Adulto , Quimioterapia Combinada , Feminino , Humanos , Pessoa de Meia-Idade , Mifepristona/efeitos adversos , Misoprostol/efeitos adversos , Satisfação do Paciente , Gravidez , Primeiro Trimestre da Gravidez , Resultado do Tratamento , Reino Unido , Adulto Jovem
18.
Contraception ; 100(2): 160-164, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31002777

RESUMO

OBJECTIVE: Data on the practice of self-managed medication abortion are limited, in part because this practice takes place purposefully outside of established healthcare systems. Given this, we aimed to ascertain abortion providers' familiarity with self-managed medication abortion and associated complications, compare regional differences and evaluate provider attitudes. STUDY DESIGN: We distributed an online survey to members of Society for Family Planning, Association of Reproductive Health Providers and the Abortion Care Network between July and September 2017 querying experiences with and opinions about self-managed abortion. RESULTS: Of 650 respondents, 359 (55.1%) were direct abortion providers. Two hundred and thirty of 335 providers (68.6%) had experience with women trying to interrupt pregnancies on their own, and of those, 153 (76.1%) had seen use of misoprostol and/or mifepristone, and 204 of 342 (59.6%) thought this practice increased in the past 5 years. One hundred and seventeen of 335 (34.9%), witnessed complications from self-managed abortion with misoprostol/mifepristone, most commonly incomplete abortion and less often hemorrhage, sepsis and uterine rupture. Half of providers, 171 of 321 (53.3%), think that the use of misoprostol/mifepristone for the self-management of abortion is safe. CONCLUSION: Two thirds of respondents had experiences with women attempting to self-manage abortion, and about a third witnessed complications related to self-managed medication abortion. About half of respondents agreed that self-managed abortion is safe. IMPLICATIONS: This study establishes that self-managed abortion is a practice which a majority of respondents have seen among their patients and, because of its prevalence, an area that warrants further research.


Assuntos
Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Induzido/estatística & dados numéricos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Aborto Incompleto/etiologia , Aborto Induzido/métodos , Adulto , Feminino , Idade Gestacional , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Mifepristona/efeitos adversos , Misoprostol/efeitos adversos , Gravidez , Saúde Reprodutiva , Autoadministração , Adulto Jovem
19.
J Obstet Gynaecol Can ; 41(5): 647-652, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31007171

RESUMO

OBJECTIVE: In January 2017, mifepristone became available in Canada. The goal of this study was to determine the effectiveness and safety of mifepristone-misoprostol abortion during its early implementation in a Canadian setting. METHODS: This retrospective chart review included the first 477 patients who had a mifepristone-misoprostol abortion from March 13 to October 31, 2017, in an urban sexual health clinic. Women with pregnancies up to 63days of gestation had an initial dating ultrasound and ß-human chorionic gonadotropin determination. They were provided mifepristone 200 mg orally in clinic, followed 24-48hours later with misoprostol 800 µg buccally at home. Follow-up, 7-14days later, in clinic or by telephone, used symptom review and follow-up ß-human chorionic gonadotropin or ultrasound. The primary outcome was successful abortion, defined as expulsion of pregnancy without uterine aspiration. RESULTS: Of 477 consecutive mifepristone abortions, 422 women (88.5%) had documented follow-up, with 408 (96.7%) successful abortions, including eight in women who had a repeat dose of misoprostol. Fourteen (3.3%) unsuccessful abortions required uterine aspiration, two (0.5%) for ongoing pregnancy and 12 (2.8%) for incomplete abortion or persistent bleeding. Seventeen women (4.0%) had emergency department visits, one (0.2%) of whom was hospitalized and three (0.7%) of whom received blood transfusion. Four women (1.0%) were treated for infection. CONCLUSION: Mifepristone-misoprostol medical abortion was safe and effective during early implementation in Canada, comparable to previously published outcomes.


Assuntos
Abortivos , Aborto Induzido , Mifepristona , Misoprostol , Abortivos/administração & dosagem , Abortivos/efeitos adversos , Abortivos/uso terapêutico , Aborto Induzido/efeitos adversos , Aborto Induzido/métodos , Aborto Induzido/estatística & dados numéricos , Administração Oral , Adolescente , Adulto , Feminino , Humanos , Mifepristona/administração & dosagem , Mifepristona/efeitos adversos , Mifepristona/uso terapêutico , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Misoprostol/uso terapêutico , Gravidez , Estudos Retrospectivos , Adulto Jovem
20.
J Obstet Gynaecol ; 39(6): 753-756, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31010345

RESUMO

Excessive bleeding during and after caesarean section is a major cause of maternal morbidity and mortality, especially in low resource countries. This study evaluates the effect of intrauterine misoprostol with oxytocin in comparison with oxytocin alone on blood loss during caesarean section. A retrospective data analysis of 160 women who underwent lower segment caesarean section was conducted. Eighty-five out of 160 (53%) women received tablet misoprostol 800 µg by intrauterine route after delivery of a baby in addition to routine oxytocin infusion (group A), while 75 women (47%) received only oxytocin (group B). Blood loss, Haemoglobin (Hb) difference (pre-operative Hb - post-operative Hb) and need of any other oxytocic were compared in both the groups. Demographic variables such as mean age, parity, and an indication of caesarean section were comparable in both the groups. Mean blood loss during caesarean section was lower in group A (680 ± 202 mL) than group B (740 ± 228 mL) (p = .08). Higher Hb difference was noted in group B (1.03 ± 0.83 gm%) than group A (0.93 ± 0.68 gm%) (p = .41). No patient required additional oxytocic and no patient had postpartum haemorrhage in both the groups. The use of misoprostol by the intrauterine route in addition to routine oxytocin infusion during caesarean section is associated with a clinically significant reduction in intra-operative and post-operative blood loss. IMPACT STATEMENT What is already known on this subject? The role of misoprostol in the prevention and treatment of haemorrhage during and after caesarean section is well known and well studied. It is a better alternative to oxytocin in low resource settings. Various routes of misoprostol, with or without oxytocin, and its effect on intrapartum and postpartum haemorrhage are described in the literature. Misoprostol is an autocoid substance and acts better if it is close to the target organ (uterus). The use of misoprostol by the intrauterine route during caesarean section has not been well explored. What do the results of this study add? The use of misoprostol by intrauterine route in addition to routine oxytocin infusion during caesarean section is associated with decreased intra-operative and post-operative -blood loss. What are the implications of these findings for clinical practice and/or further research? The findings of this study reveal that misoprostol is also effective by the intrauterine route. It is a convenient way to insert misoprostol during caesarean section and it can be considered to prevent intrapartum and postpartum haemorrhage. More studies including randomised controlled trials with bigger sample size are needed to reach to any firm conclusion.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Cesárea/efeitos adversos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Útero/efeitos dos fármacos , Adulto , Cesárea/métodos , Feminino , Humanos , Misoprostol/efeitos adversos , Ocitocina/administração & dosagem , Hemorragia Pós-Parto/prevenção & controle , Gravidez
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