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1.
Tidsskr Nor Laegeforen ; 1412021 09 28.
Artigo em Inglês, Norueguês | MEDLINE | ID: mdl-34597001

RESUMO

BACKGROUND: Previous caesarean section is considered the main risk factor for uterine rupture. However, other surgical procedures performed on the uterus can also lead to rupture in future pregnancies. CASE PRESENTATION: The patient was a nulliparous woman, induced at gestational age of 41 + 6 with misoprostol. She developed severe persistent abdominal pain. Due to fetal bradycardia, an acute caesarean section was performed. Peroperatively a large rupture was identified in the uterine fundus and the placenta was detached into the abdomen. Medical history included a previous rightsided salpingectomy due to an extrauterine pregnancy located in the interstitial part of the right Fallopian tube. INTERPRETATION: Interstitial extrauterine pregnancy is rare, and recommendations for mode of delivery for subsequent pregnancies remain unclear. The current case illustrates the importance of being aware of the risk of rupture when the patient has undergone previous gynaecological surgery other than caesarean section, and of ensuring awareness of the placenta's location.


Assuntos
Misoprostol , Complicações na Gravidez , Ruptura Uterina , Cesárea , Feminino , Humanos , Paridade , Gravidez , Ruptura Uterina/etiologia , Ruptura Uterina/cirurgia
2.
BMC Res Notes ; 14(1): 355, 2021 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-34507611

RESUMO

OBJECTIVES: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15. DATA DESCRIPTION: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.


Assuntos
Hipertensão , Misoprostol , Ocitócicos , Cateteres , Maturidade Cervical , Feminino , Humanos , Índia , Recém-Nascido , Trabalho de Parto Induzido , Gravidez
3.
JNMA J Nepal Med Assoc ; 59(236): 396-398, 2021 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-34508522

RESUMO

Anencephaly is a condition in which there is an absence of skull and brain tissues. Absence of cranial vault mainly results because of defective neurulation. Absence of cerebral tissues may cause diminished heart size, due to decreased heart load causing various cardiac abnormalities. Here, we report a case of a primigravida lady at 17 weeks of gestation with misoprostol induced expulsion of fetus after ultrasonography revealed absence of brain tissue and calvarium above the orbits suggesting anencephaly. A 300g fetus was delivered which confirmed the ultrasound findings. The patient was discharged with advice for intake of folic acid beginning from 3 months before conception in future pregnancies. Neural tube defects can manifest within approximately 28 days of gestation which highlights the importance of oral folic acid intake before pregnancy.


Assuntos
Anencefalia , Misoprostol , Defeitos do Tubo Neural , Anencefalia/diagnóstico por imagem , Feminino , Feto , Humanos , Misoprostol/efeitos adversos , Gravidez , Ultrassonografia
4.
Cochrane Database Syst Rev ; 6: CD014484, 2021 06 22.
Artigo em Inglês | MEDLINE | ID: mdl-34155622

RESUMO

BACKGROUND: Misoprostol given orally is a commonly used labour induction method. Our Cochrane Review is restricted to studies with low-dose misoprostol (initially ≤ 50 µg), as higher doses pose unacceptably high risks of uterine hyperstimulation. OBJECTIVES: To assess the efficacy and safety of low-dose oral misoprostol for labour induction in women with a viable fetus in the third trimester of pregnancy. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov,  the WHO International Clinical Trials Registry Platform (14 February 2021) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials comparing low-dose oral misoprostol (initial dose ≤ 50 µg) versus placebo, vaginal dinoprostone, vaginal misoprostol, oxytocin, or mechanical methods; or comparing oral misoprostol protocols (one- to two-hourly versus four- to six-hourly; 20 µg to 25 µg versus 50 µg; or 20 µg hourly titrated versus 25 µg two-hourly static). DATA COLLECTION AND ANALYSIS: Using Covidence, two review authors independently screened reports, extracted trial data, and performed quality assessments. Our primary outcomes were vaginal birth within 24 hours, caesarean section, and hyperstimulation with foetal heart changes. MAIN RESULTS: We included 61 trials involving 20,026 women. GRADE assessments ranged from moderate- to very low-certainty evidence, with downgrading decisions based on imprecision, inconsistency, and study limitations. Oral misoprostol versus placebo/no treatment (four trials; 594 women) Oral misoprostol may make little to no difference in the rate of caesarean section (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.59 to 1.11; 4 trials; 594 women; moderate-certainty evidence), while its effect on uterine hyperstimulation with foetal heart rate changes is uncertain (RR 5.15, 95% CI 0.25 to 105.31; 3 trials; 495 women; very low-certainty evidence). Vaginal births within 24 hours was not reported. In all trials, oxytocin could be commenced after 12 to 24 hours and all women had pre-labour ruptured membranes. Oral misoprostol versus vaginal dinoprostone (13 trials; 9676 women) Oral misoprostol probably results in fewer caesarean sections (RR 0.84, 95% CI 0.78 to 0.90; 13 trials, 9676 women; moderate-certainty evidence). Subgroup analysis indicated that 10 µg to 25 µg (RR 0.80, 95% CI 0.74 to 0.87; 9 trials; 8652 women) may differ from 50 µg (RR 1.10, 95% CI 0.91 to 1.34; 4 trials; 1024 women) for caesarean section. Oral misoprostol may decrease vaginal births within 24 hours (RR 0.93, 95% CI 0.87 to 1.00; 10 trials; 8983 women; low-certainty evidence) and hyperstimulation with foetal heart rate changes (RR 0.49, 95% CI 0.40 to 0.59; 11 trials; 9084 women; low-certainty evidence). Oral misoprostol versus vaginal misoprostol (33 trials; 6110 women) Oral use may result in fewer vaginal births within 24 hours (average RR 0.81, 95% CI 0.68 to 0.95; 16 trials, 3451 women; low-certainty evidence), and less hyperstimulation with foetal heart rate changes (RR 0.69, 95% CI 0.53 to 0.92, 25 trials, 4857 women, low-certainty evidence), with subgroup analysis suggesting that 10 µg to 25 µg orally (RR 0.28, 95% CI 0.14 to 0.57; 6 trials, 957 women) may be superior to 50 µg orally (RR 0.82, 95% CI 0.61 to 1.11; 19 trials; 3900 women). Oral misoprostol probably does not increase caesarean sections overall (average RR 1.00, 95% CI 0.86 to 1.16; 32 trials; 5914 women; low-certainty evidence) but likely results in fewer caesareans for foetal distress (RR 0.74, 95% CI 0.55 to 0.99; 24 trials, 4775 women). Oral misoprostol versus intravenous oxytocin (6 trials; 737 women, 200 with ruptured membranes) Misoprostol may make little or no difference to vaginal births within 24 hours (RR 1.12, 95% CI 0.95 to 1.33; 3 trials; 466 women; low-certainty evidence), but probably results in fewer caesarean sections (RR 0.67, 95% CI 0.50 to 0.90; 6 trials; 737 women; moderate-certainty evidence). The effect on hyperstimulation with foetal heart rate changes is uncertain (RR 0.66, 95% CI 0.19 to 2.26; 3 trials, 331 women; very low-certainty evidence). Oral misoprostol versus mechanical methods (6 trials; 2993 women) Six trials compared oral misoprostol to transcervical Foley catheter. Misoprostol may increase vaginal birth within 24 hours (RR 1.32, 95% CI 0.98 to 1.79; 4 trials; 1044 women; low-certainty evidence), and probably reduces the risk of caesarean section (RR 0.84, 95% CI 0.75 to 0.95; 6 trials; 2993 women; moderate-certainty evidence). There may be little or no difference in hyperstimulation with foetal heart rate changes (RR 1.31, 95% CI 0.78 to 2.21; 4 trials; 2828 women; low-certainty evidence). Oral misoprostol one- to two-hourly versus four- to six-hourly (1 trial; 64 women) The evidence on hourly titration was very uncertain due to the low numbers reported. Oral misoprostol 20 µg hourly titrated versus 25 µg two-hourly static (2 trials; 296 women) The difference in regimen may have little or no effect on the rate of vaginal births in 24 hours (RR 0.97, 95% CI 0.80 to 1.16; low-certainty evidence). The evidence is of very low certainty for all other reported outcomes. AUTHORS' CONCLUSIONS: Low-dose oral misoprostol is probably associated with fewer caesarean sections (and therefore more vaginal births) than vaginal dinoprostone, and lower rates of hyperstimulation with foetal heart rate changes. However, time to birth may be increased, as seen by a reduced number of vaginal births within 24 hours. Compared to transcervical Foley catheter, low-dose oral misoprostol is associated with fewer caesarean sections, but equivalent rates of hyperstimulation. Low-dose misoprostol given orally rather than vaginally is probably associated with similar rates of vaginal birth, although rates may be lower within the first 24 hours. However, there is likely less hyperstimulation with foetal heart changes, and fewer caesarean sections performed due to foetal distress. The best available evidence suggests that low-dose oral misoprostol probably has many benefits over other methods for labour induction. This review supports the use of low-dose oral misoprostol for induction of labour, and demonstrates the lower risks of hyperstimulation than when misoprostol is given vaginally. More trials are needed to establish the optimum oral misoprostol regimen, but these findings suggest that a starting dose of 25 µg may offer a good balance of efficacy and safety.


Assuntos
Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Administração Intravaginal , Administração Oral , Índice de Apgar , Cesárea/estatística & dados numéricos , Dinoprostona/administração & dosagem , Esquema de Medicação , Feminino , Frequência Cardíaca Fetal/efeitos dos fármacos , Humanos , Terapia Intensiva Neonatal/estatística & dados numéricos , Ocitocina/administração & dosagem , Parto , Placebos/administração & dosagem , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Útero/efeitos dos fármacos
5.
BJOG ; 128(11): 1752-1761, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34138505

RESUMO

OBJECTIVE: To explore the experiences of women in Scotland who accessed medical abortion at home up to 12 weeks' gestation, delivered via a telemedicine abortion service implemented in response to the coronavirus (COVID-19) pandemic, to identify areas for improvement and inform service provision. DESIGN: Qualitative interview study. SETTING: Abortion service in one National Health Service health board in Scotland. POPULATION OR SAMPLE: Twenty women who accessed telemedicine abortion services and self-administered mifepristone and misoprostol at home up to 12 weeks' gestation. METHODS: Thematic analysis of semi-structured qualitative interviews, informed by the Framework analytic approach. MAIN OUTCOME MEASURES: Women's experiences of accessing telemedicine for medical abortion at home, specifically: acceptability of the telephone consultation and remote support; views on no pre-abortion ultrasound scan; and self-administration of abortion medications at home. RESULTS: Novel study findings were three-fold: (1) participants valued the option of accessing abortion care via telemedicine and emphasised the benefits of providing a choice of telephone and in-person consultation to suit those with different life circumstances; (2) the quality of abortion care was enhanced by the telemedicine service in relation to access, comfort and flexibility, and ongoing telephone support; (3) participants described being comfortable with, and in some cases a preference for, not having an ultrasound scan. CONCLUSIONS: This research demonstrates support for the continuation of telemedicine abortion services beyond the temporary arrangements in place during COVID-19, and lends weight to the argument that offering the option of telemedicine abortion care can enable women to access this essential health service. TWEETABLE ABSTRACT: #Telemedicine provision of medical #abortion at home up to 12 weeks' gestation is acceptable and highly valued by #women #Research #SRHR @nbw80 @doctorjjrw @jeniharden @cameronsharon @mrc_crh @edinuniusher.


Assuntos
Abortivos não Esteroides/administração & dosagem , Aborto Induzido/métodos , Satisfação do Paciente , Autoadministração/psicologia , Telemedicina/métodos , Aborto Induzido/psicologia , Adulto , COVID-19 , Feminino , Acesso aos Serviços de Saúde , Humanos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Gravidez , Pesquisa Qualitativa , SARS-CoV-2 , Escócia , Medicina Estatal
6.
J Obstet Gynaecol Res ; 47(9): 3171-3178, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34162016

RESUMO

AIM: To compare the efficacy and safety of dinoprostone vaginal insert (DVI) alone versus DVI with adjunctive sweeping of membranes (ASM) for induction of labor (IOL). METHODS: Single-center, prospective, randomized controlled trial; women with singleton term pregnancies, cervical dilation ≥1 and <3 cm, intact membranes allocated to either DVI or DVI with ASM. The primary outcome was vaginal delivery within 24 h of insertion. Secondary outcomes included mean time from insertion to delivery, tachysystole, operative delivery for non-reassuring fetal status (NRFS), tocolytics, fetal outcomes, pain information, and subject satisfaction. RESULTS: One hundred and four received DVI (Group 1) alone and 104 DVI with ASM (Group 2). The rate of vaginal delivery within 24 h was 53% versus 56%, cesarean rate 8.7% versus 10.6% in Groups 1 and 2 respectively. Although the duration of labor was similar in both groups, about 6% of women required additional ripening with dinoprostone vaginal tablets in Group 2 compared to 11.5% in Group 1 (p-value = 0.2). The frequency of hyperstimulation syndrome, failed induction, analgesic requirements, and fetal outcomes were comparable. The majority (83%-86%) in either cohort were satisfied with their labor experience. Multivariate logistic regression demonstrated a slightly better chance for vaginal delivery within 24 h (odds ratio [OR] 1.22 [95% confidence interval, CI 0.65-2.29]; p-value 0.53] for DVI with ASM, although statistically insignificant. Younger maternal age and multiparity (OR 10.36 [95% CI 4.88-23.67]; p-value <0.0001) contributed to successful IOL. CONCLUSION: DVI with ASM is at least as efficacious as DVI for cervical ripening with no increase in morbidity. Although DVI with ASM group less often needed additional dinoprostone tablets to complete the process of IOL (p-value = 0.2), adjunctive sweeping has not been shown to have a significant impact on the duration of labor or mode of delivery.


Assuntos
Misoprostol , Ocitócicos , Administração Intravaginal , Maturidade Cervical , Dinoprostona , Feminino , Humanos , Trabalho de Parto Induzido , Gravidez , Estudos Prospectivos
7.
Cochrane Database Syst Rev ; 6: CD012602, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34061352

RESUMO

BACKGROUND: Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime. An estimated 15% of pregnancies end in miscarriage. Miscarriage can lead to serious morbidity, including haemorrhage, infection, and even death, particularly in settings without adequate healthcare provision. Early miscarriages occur during the first 14 weeks of pregnancy, and can be managed expectantly, medically or surgically. However, there is uncertainty about the relative effectiveness and risks of each option. OBJECTIVES: To estimate the relative effectiveness and safety profiles for the different management methods for early miscarriage, and to provide rankings of the available methods according to their effectiveness, safety, and side-effect profile using a network meta-analysis. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth's Trials Register (9 February 2021), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (12 February 2021), and reference lists of retrieved studies. SELECTION CRITERIA: We included all randomised controlled trials assessing the effectiveness or safety of methods for miscarriage management. Early miscarriage was defined as less than or equal to 14 weeks of gestation, and included missed and incomplete miscarriage. Management of late miscarriages after 14 weeks of gestation (often referred to as intrauterine fetal deaths) was not eligible for inclusion in the review. Cluster- and quasi-randomised trials were eligible for inclusion. Randomised trials published only as abstracts were eligible if sufficient information could be retrieved. We excluded non-randomised trials. DATA COLLECTION AND ANALYSIS: At least three review authors independently assessed the trials for inclusion and risk of bias, extracted data and checked them for accuracy. We estimated the relative effects and rankings for the primary outcomes of complete miscarriage and composite outcome of death or serious complications. The certainty of evidence was assessed using GRADE. Relative effects for the primary outcomes are reported subgrouped by the type of miscarriage (incomplete and missed miscarriage). We also performed pairwise meta-analyses and network meta-analysis to determine the relative effects and rankings of all available methods. MAIN RESULTS: Our network meta-analysis included 78 randomised trials involving 17,795 women from 37 countries. Most trials (71/78) were conducted in hospital settings and included women with missed or incomplete miscarriage. Across 158 trial arms, the following methods were used: 51 trial arms (33%) used misoprostol; 50 (32%) used suction aspiration; 26 (16%) used expectant management or placebo; 17 (11%) used dilatation and curettage; 11 (6%) used mifepristone plus misoprostol; and three (2%) used suction aspiration plus cervical preparation. Of these 78 studies, 71 (90%) contributed data in a usable form for meta-analysis. Complete miscarriage Based on the relative effects from the network meta-analysis of 59 trials (12,591 women), we found that five methods may be more effective than expectant management or placebo for achieving a complete miscarriage: · suction aspiration after cervical preparation (risk ratio (RR) 2.12, 95% confidence interval (CI) 1.41 to 3.20, low-certainty evidence), · dilatation and curettage (RR 1.49, 95% CI 1.26 to 1.75, low-certainty evidence), · suction aspiration (RR 1.44, 95% CI 1.29 to 1.62, low-certainty evidence), · mifepristone plus misoprostol (RR 1.42, 95% CI 1.22 to 1.66, moderate-certainty evidence), · misoprostol (RR 1.30, 95% CI 1.16 to 1.46, low-certainty evidence). The highest ranked surgical method was suction aspiration after cervical preparation. The highest ranked non-surgical treatment was mifepristone plus misoprostol. All surgical methods were ranked higher than medical methods, which in turn ranked above expectant management or placebo. Composite outcome of death and serious complications Based on the relative effects from the network meta-analysis of 35 trials (8161 women), we found that four methods with available data were compatible with a wide range of treatment effects compared with expectant management or placebo: · dilatation and curettage (RR 0.43, 95% CI 0.17 to 1.06, low-certainty evidence), · suction aspiration (RR 0.55, 95% CI 0.23 to 1.32, low-certainty evidence), · misoprostol (RR 0.50, 95% CI 0.22 to 1.15, low-certainty evidence), · mifepristone plus misoprostol (RR 0.76, 95% CI 0.31 to 1.84, low-certainty evidence). Importantly, no deaths were reported in these studies, thus this composite outcome was entirely composed of serious complications, including blood transfusions, uterine perforations, hysterectomies, and intensive care unit admissions. Expectant management and placebo ranked the lowest when compared with alternative treatment interventions. Subgroup analyses by type of miscarriage (missed or incomplete) agreed with the overall analysis in that surgical methods were the most effective treatment, followed by medical methods and then expectant management or placebo, but there are possible subgroup differences in the effectiveness of the available methods.  AUTHORS' CONCLUSIONS: Based on relative effects from the network meta-analysis, all surgical and medical methods for managing a miscarriage may be more effective than expectant management or placebo. Surgical methods were ranked highest for managing a miscarriage, followed by medical methods, which in turn ranked above expectant management or placebo. Expectant management or placebo had the highest chance of serious complications, including the need for unplanned or emergency surgery. A subgroup analysis showed that surgical and medical methods may be more beneficial in women with missed miscarriage compared to women with incomplete miscarriage. Since type of miscarriage (missed and incomplete) appears to be a source of inconsistency and heterogeneity within these data, we acknowledge that the main network meta-analysis may be unreliable. However, we plan to explore this further in future updates and consider the primary analysis as separate networks for missed and incomplete miscarriage.


Assuntos
Aborto Espontâneo/terapia , Primeiro Trimestre da Gravidez , Aborto Incompleto/terapia , Aborto Retido/terapia , Quimioterapia Combinada , Feminino , Humanos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Metanálise em Rede , Ocitócicos/administração & dosagem , Placebos/administração & dosagem , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Sucção/estatística & dados numéricos , Curetagem a Vácuo/estatística & dados numéricos , Conduta Expectante/estatística & dados numéricos
8.
Issues Law Med ; 36(1): 3-26, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33939340

RESUMO

Objectives: Primary: Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient. Secondary: Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone. Methods: Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3). Results: The FDA provided 6158 pages of AERs. Duplicates, non-US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs. (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%). Conclusions: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.A mandatory registry of ongoing pregnancies is essential considering the number of ongoing pregnancies especially considering the known teratogenicity of misoprostol.The decision to prevent the FDA from enforcing REMS during the COVID-19 pandemic needs to be reversed and REMS must be strengthened.


Assuntos
Abortivos , Mifepristona/efeitos adversos , Abortivos/efeitos adversos , Abortivos Esteroides/efeitos adversos , Aborto Induzido/efeitos adversos , COVID-19 , Feminino , Humanos , Misoprostol , Pandemias , Gravidez , SARS-CoV-2
9.
Obstet Gynecol ; 137(6): 1055-1060, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33957651

RESUMO

OBJECTIVE: To compare the effect of cervical priming with mifepristone with that of misoprostol on pain perception during surgical induced abortion under paracervical block. METHODS: We conducted a randomized, single-blind, two-center study of women undergoing surgical induced abortion at less than 14 weeks of gestation under paracervical block. Participants were randomized to receive cervical priming with 200 mg of oral mifepristone 36 hours or 400 micrograms buccal misoprostol 3 hours before surgery. The primary outcome was pain during mechanical cervical dilation evaluated by a 100-mm visual analog scale (VAS). Secondary outcomes were pain during aspiration, preoperative and postoperative pain, participant satisfaction, duration of the procedure, occurrence of complications, and ease of performing the procedure (assessed by a 100-mm VAS). We estimated that 110 women would have to be included to have 90% power to detect a 13mm-difference of VAS for pain. RESULTS: Between June 2017 and May 2019, 314 women were eligible and 110 were randomized (55 in each group). Patient characteristics were similar in the two groups. The mean VAS score during mechanical cervical dilation was lower in the mifepristone group (35.6±21 vs 43.5±21, P=.04) as was the mean VAS during aspiration (34±24 vs 47.8±23, P=.003). The preoperative and postoperative mean VAS, satisfaction and duration of procedures were similar between groups. The procedure was significantly easier to perform in the mifepristone group (88±16 vs 80±23, P=.004). CONCLUSION: Cervical priming with mifepristone for surgical induced abortion under paracervical block up to 14 weeks of gestation is more effective than misoprostol in reducing pain perception. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03043014.


Assuntos
Abortivos não Esteroides/uso terapêutico , Abortivos Esteroides/uso terapêutico , Aborto Induzido/efeitos adversos , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Dor Processual/prevenção & controle , Aborto Induzido/métodos , Adulto , Anestesia Obstétrica , Feminino , Humanos , Medição da Dor , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/prevenção & controle , Dor Processual/etiologia , Satisfação do Paciente , Gravidez , Primeiro Trimestre da Gravidez , Método Simples-Cego , Adulto Jovem
10.
BJOG ; 128(9): 1534-1545, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33969614

RESUMO

OBJECTIVE: To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. DESIGN: Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS). SETTING: Twenty-eight UK NHS early pregnancy units. SAMPLE: A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage. METHODS: Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets. MAIN OUTCOME MEASURES: Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs). RESULTS: For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management. CONCLUSIONS: The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage. TWEETABLE ABSTRACT: The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.


Assuntos
Abortivos/administração & dosagem , Aborto Retido/tratamento farmacológico , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Abortivos/economia , Aborto Retido/economia , Adolescente , Adulto , Análise Custo-Benefício , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Mifepristona/economia , Misoprostol/economia , Gravidez , Adulto Jovem
11.
BMC Pregnancy Childbirth ; 21(1): 355, 2021 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-33947349

RESUMO

BACKGROUND: Although labor induction is a commonly used procedure in obstetrical care, there are limited data on its psycho-emotional effects on the woman. This study analysed the expectations and experiences of women in different routes of labor induction. The study's primary aim was to compare women's delivery experience if induced by orally administrated misoprostol (OMS) compared with misoprostol vaginal insert (MVI). Secondly, an evaluation of women's general satisfaction with induced labor was made, and factors associated with a negative experience. METHODS: Primiparous women (n = 196) with a singleton fetus in cephalic presentation, ≥ 37 weeks of gestation, with a Bishop's score ≤ 4 planning labor induction were randomly allocated to receive either OMS (Cytotec®) or MVI (Misodel®). Data were collected by validated questionnaires, the Wijma Delivery Expectation/Experience Questionnaire (A + B). The pre-labor part of the survey (W-DEQ version A) was given to participants to complete within 1 hour before the start of induction, and the post-labor part of the questionnaire (W-DEQ version B) was administered after birth and collected before the women were discharged from hospital. RESULTS: It was found that 11.8% (17/143) reported a severe fear of childbirth (W-DEQ A score ≥ 85). Before the induction, women with extreme fear had 3.7 times increased risk of experiencing labor induction negatively (OR 3.7 [95% CI, 1.04-13.41]). CONCLUSION: No difference was identified between OMS and MVI when delivery experience among women induced to labor was analysed. Severe fear of childbirth before labor was a risk factor for a negative experience of labor induction. TRIAL REGISTRATION: Clinical trial register number NCT02918110 . Date of registration on May 31, 2016.


Assuntos
Trabalho de Parto Induzido/psicologia , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Administração Intravaginal , Administração Oral , Adulto , Medo , Feminino , Humanos , Recém-Nascido , Masculino , Parto/psicologia , Gravidez , Fatores de Risco , Inquéritos e Questionários
12.
Reprod Health ; 18(1): 91, 2021 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-33947413

RESUMO

BACKGROUND: A growing body of evidence indicates that some people seek options to terminate a pregnancy without medical assistance, but experiences doing so have largely been documented only among people accessing a clinic-based abortion. We aim to describe self-managed abortion (SMA) experiences of people recruited outside of clinics, including their motivations for SMA, pregnancy confirmation and decision-making processes, method choices, and clinical outcomes. METHODS: In 2017, we conducted 14 in-depth interviews with self-identified females of reproductive age who recently reported in an online survey administered to Ipsos' KnowledgePanel that, since 2000, they had attempted SMA while living in the United States. We asked participants about their reproductive histories, experiences seeking reproductive health care, and SMA experiences. We used an iterative process to develop codes and analyzed transcripts using thematic content analysis methods. RESULTS: Motivations and perceptions of effectiveness varied by whether participants had confirmed the pregnancy prior to SMA. Participants who confirmed their pregnancies chose SMA because it was convenient, accessible, and private. Those who did not test for pregnancy were motivated by a preference for autonomy and felt empowered by the ability to try something on their own before seeking facility-based care. Participants prioritized methods that were safe and available, though not always effective. Most used herbs or over-the-counter medications; none used self-sourced abortion medications, mifepristone and/or misoprostol. Five participants obtained facility-based abortions and one participant decided to continue the pregnancy after attempting SMA. The remaining eight reported being no longer pregnant after SMA. None of the participants sought care for  SMA complications; one participant saw a provider to confirm abortion completion. CONCLUSIONS: There are many types of SMA experiences. In addition to those who pursue SMA as a last resort (after facing barriers to facility-based care) or as a first resort (because they prefer homeopathic remedies), our findings show that some individuals view SMA as a potential interim step worth trying after suspecting pregnancy and before accessing facility-based care. These people in particular would benefit from a medication abortion product available over the counter, online, or in the form of a missed-period pill.


Assuntos
Aborto Induzido/métodos , Aborto Espontâneo , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Autogestão , Adulto , Feminino , Acesso aos Serviços de Saúde , Humanos , Entrevistas como Assunto , Motivação , Gravidez , Pesquisa Qualitativa , Estados Unidos
13.
J Pharm Biomed Anal ; 202: 114138, 2021 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-34022668

RESUMO

Misoprostol is a prostaglandin E1 synthetic analogous used for elective interruptions of early pregnancy, treatment of incomplete abortion, postpartum hemorrhage and induction of full-term labor. Its a lipophilic drug, passing by extensive and rapid pre-systemic metabolism into the active metabolite, misoprostol acid (MA). The objective of this study was to develop and validate a highly sensitive method for MA determination in plasma using UPLC-MSMS, with application in a study of maternal-fetal pharmacokinetics in healthy parturients women (n = 10) after administration of 25 µg misoprostol vaginally. The method presented linearity of 2-10 pg/mL and acceptable precision, accuracy, plasma and solution stability. The parturients women presented median (interquartile range) values of AUC0-6 of 68.0 (40.8-84.7) pg.h/mL, Cmax of 21.9 (11.9-30.1) pg/mL and Tmax of 2.25 (0.69-5.00) h. The placental transfer of MA was assessed from the umbilical vein/maternal blood ratios of 1.40 (0.91-2.13) and intervillous space/maternal blood ratios of 0.49 (0.15-3.41). In conclusion, this method presented high sensitivity, being able to quantify MA in plasma samples following a low 25 µg misoprostol administered vaginally aimed to induce labor in parturients women. Additionally, this is the first description of the placental transfer of MA after a vaginal administration of misoprostol.


Assuntos
Misoprostol , Administração Intravaginal , Cromatografia Líquida de Alta Pressão , Cromatografia Líquida , Feminino , Humanos , Trabalho de Parto Induzido , Misoprostol/análogos & derivados , Placenta , Gravidez , Espectrometria de Massas em Tandem
14.
Health Res Policy Syst ; 19(Suppl 1): 62, 2021 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-33882966

RESUMO

BACKGROUND: Pakistan is among a number of countries facing protracted challenges in addressing maternal mortality with a concomitant weak healthcare system complexed with inequities. Sexual and reproductive health and rights (SRHR) self-care interventions offer the best solution for improving access to quality healthcare services with efficiency and economy. This manuscript documents country experience in introducing and scaling up two selected SRHR self-care interventions. A prospective qualitative study design was used and a semi-structured questionnaire was shared with identified SRHR private sector partners selected through convenience and purposive sampling. The two interventions include the use of misoprostol for postpartum hemorrhage and the use of subcutaneous depomedroxyprogesterone acetate (DMPA) as injectable contraceptive method. Data collection was done through emails and telephone follow-up calls. RESULTS: Nine of the 13 partners consulted for the study responded. The two selected self-care interventions are mainly supported by private sector partners (national and international nongovernmental organizations) having national or subnational existence. Their mandates include all relevant areas, such as policy advocacy, field implementation, trainings, supervision and monitoring. A majority of partners reported experience related to the use of misoprostol; it was introduced more than a decade ago, is registered and is procured by both public and private sectors. Subcutaneous DMPA is a new intervention, having been introduced only recently, and commodity availability remains a challenge. It is being delivered through health workers/providers and is not promoted as a self-administered contraceptive. Community engagement and awareness raising is reported as an essential element of successful field implementation; however, no beneficiary data was collected for the study. Training approaches differ considerably, are standalone or integrated with SRHR topics and their duration varies between 1 and 5 days, covering a range of cadres. CONCLUSION: Pubic sector ownership and patronage is essential for introducing and scaling up self-care interventions as a measure to support the healthcare system in delivering quality sexual and reproductive health services. Supervision, monitoring and reporting are areas requiring further support, as well as the leadership and governance role of the public sector. Standardization of trainings, community awareness, supervision, monitoring and reporting are required together with integration of self-care in routine capacity building activities (pre- and in-service) on sexual and reproductive health in the country.


Assuntos
Misoprostol , Feminino , Humanos , Paquistão , Gravidez , Setor Privado , Estudos Prospectivos , Autocuidado
15.
Obstet Gynecol ; 137(5): 801-809, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33831935

RESUMO

OBJECTIVE: To assess the efficacy of pretreatment with mifepristone before misoprostol, compared with misoprostol alone, for termination of pregnancy after a fetal death in the second trimester. METHODS: This prospective, double blind, placebo-controlled trial randomized women requiring a termination of pregnancy after fetal death between 14 and 28 weeks of gestation to placebo or 200 mg mifepristone orally 24-48 hours before the termination of pregnancy with misoprostol (400 micrograms every 6 hours vaginally for women at 24 weeks of gestation or less, and 200 micrograms every 4 hours vaginally for women at 24 weeks of gestation or more). Based on a median labor with misoprostol alone in the second trimester of 13 hours, a sample size of 116 women per group was planned to compare the primary outcome of time from administration of misoprostol to delivery. The trial was ceased after 66 women were enrolled secondary to prolonged time to achieve recruitment. RESULTS: From April 2013 to November 2016, 66 women were randomized (34 to placebo and 32 to mifepristone). There were no differences in the characteristics between the two groups. The median time for the primary outcome of administration of misoprostol to delivery in the placebo group was 10.5 hours, compared with 6.8 hours in the treatment group (hazard ratio 2.41 95% CI 1.39-4.17, P=.002). Women in the placebo group required more doses of misoprostol (3.4 vs 2.1, P=.002) and more misoprostol overall (1,181.8 micrograms, vs 767.7 micrograms, P=.003). There was no difference in maternal complications between the two groups. Women in the mifepristone group reported improved perception of the procedure. CONCLUSION: The sequential use of mifepristone and misoprostol for the termination of pregnancy after fetal deaths between 14 and 28 weeks of gestation reduces the time to delivery, compared with the use of misoprostol alone, with no worsening of maternal complications. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12612000884808.


Assuntos
Abortivos , Aborto Induzido , Mifepristona , Misoprostol , Adulto , Método Duplo-Cego , Feminino , Morte Fetal , Humanos , Gravidez , Segundo Trimestre da Gravidez , Estudos Prospectivos , Resultado do Tratamento , Adulto Jovem
16.
N Z Med J ; 134(1533): 61-70, 2021 04 16.
Artigo em Inglês | MEDLINE | ID: mdl-33927424

RESUMO

AIMS: To evaluate the approach to diagnosis and management of caesarean scar pregnancy (CSP) at a regional New Zealand hospital. METHODS: A retrospective case series of ten patients between June 2015 and May 2020. The data review included demographic information, ultrasound findings, human chorionic gonadotropin (HCG) levels, primary and subsequent treatment, outcomes and complications. RESULTS: Nine women were diagnosed with CSP at a gestational age between four and ten weeks. One of these women was treated twice for two separate CSP within the study period. Treatment varied according to clinical presentation, HCG levels, gestational age, ultrasound findings and patient preference. Two thirds of women were successfully treated with primary management, with one third requiring multiple treatment modalities. We report one severe life-threatening haemorrhage and three cases resulting in hysterectomy. We also show a disproportionate number of Maori women presenting with CSP. CONCLUSION: We present a series of ten cases of CSP and demonstrate similar challenges in regional New Zealand to those reported elsewhere. Management is heterogeneous with little guidance from the literature, and primary management was successful in seven out of ten cases. We report a disproportionately high number of cases in Maori women. Our results would support the development of a national register for caesarean scar pregnancy to improve diagnosis and management across New Zealand.


Assuntos
Cesárea/efeitos adversos , Cicatriz/patologia , Gravidez Ectópica/patologia , Gravidez Ectópica/terapia , Dor Abdominal/etiologia , Abortivos não Esteroides/uso terapêutico , Adulto , Cicatriz/etiologia , Dilatação e Curetagem , Feminino , Humanos , Histerectomia , Metotrexato/uso terapêutico , Misoprostol/uso terapêutico , Nova Zelândia , Grupo com Ancestrais Oceânicos , Gravidez , Gravidez Ectópica/diagnóstico por imagem , Gravidez Ectópica/etnologia , Estudos Retrospectivos , Ultrassonografia Pré-Natal , Hemorragia Uterina/etiologia
17.
Am Fam Physician ; 103(8): 473-480, 2021 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-33856168

RESUMO

Medication regimens using mifepristone and misoprostol are safe and effective for outpatient treatment of early pregnancy loss for up to 84 days' gestation and for medication abortion up to 77 days' gestation. Gestational age is determined using ultrasonography or menstrual history. Ultrasonography is needed when gestational dating cannot be confirmed using clinical data alone or when there are risk factors for ectopic pregnancy. The most effective regimens for medication management of early pregnancy loss and medication abortion include 200 mg of oral mifepristone (a progesterone receptor antagonist) followed by 800 mcg of misoprostol (a prostaglandin E1 analogue) administered buccally or vaginally. Cramping and bleeding are expected effects of the medications, with bleeding lasting an average of nine to 16 days. The adverse effects of misoprostol (e.g., low-grade fever, gastrointestinal symptoms) can be managed with nonsteroidal anti-inflammatory drugs or antiemetics. Ongoing pregnancy, infection, hemorrhage, undiagnosed ectopic pregnancy, and the need for unplanned uterine aspiration are rare complications. Clinical history, combined with serial quantitative beta human chorionic gonadotropin levels, urine pregnancy testing, or ultrasonography, is used to establish complete passage of the pregnancy tissue.


Assuntos
Abortivos não Esteroides/administração & dosagem , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Aborto Induzido , Aborto Espontâneo , Feminino , Humanos , Mifepristona/efeitos adversos , Misoprostol/efeitos adversos , Gravidez , Cuidado Pré-Natal
18.
Aust N Z J Obstet Gynaecol ; 61(4): 554-562, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33734433

RESUMO

BACKGROUND: Oral misoprostol is widely used for induction of labour (IOL) in developing countries because of its many advantages. However, limited data exist concerning its safety and efficacy when lower doses are used. AIM: To determine the safety and efficacy of a low-dose oral misoprostol regimen (commencing at 12 µg) compared to a standard-dose regimen (commencing at 25 µg) in Papua New Guinea (PNG) women undergoing IOL. MATERIALS AND METHODS: This was an open-label non-inferiority randomised controlled trial conducted at a provincial hospital in PNG. Women with singleton pregnancies ≥36 weeks with cephalic presentation and a Bishops score of <6, requiring IOL were enrolled. Both regimens were incremented second-hourly to a maximum required dose within 24 h or until commencement of labour. The primary outcome was the proportion of women who delivered within 24 h of drug administration without any severe adverse events. RESULTS: Of the 262 women induced (130 standard-dose vs 132 low-dose), rates of successful induction were high for both regimens (120/130 (92%) vs 118/132 (89%); P = 0.52). Fourteen women (11%) in the standard-dose regimen and 20 (15%) in the low-dose regimen had severe adverse events. There was no significant difference in the safety profile of the two regimens (106/130 (82%) vs 98/132 (74%); P = 0.18). The induction-to-delivery time was significantly shorter in the standard-dose arm (15.2 ± 8.7 h vs 18.0 ± 9.1 h; P = 0.01). CONCLUSION: The standard-dose regimen for IOL has greater efficacy in reducing induction-to-delivery time compared to the low-dose regimen. There was no significant difference in the number of adverse events between the two regimens.


Assuntos
Misoprostol , Ocitócicos , Administração Intravaginal , Administração Oral , Feminino , Humanos , Trabalho de Parto Induzido , Misoprostol/efeitos adversos , Ocitócicos/efeitos adversos , Papua Nova Guiné , Gravidez
19.
Ultrasound Med Biol ; 47(6): 1573-1585, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33785226

RESUMO

Uterine fibroids (UFs) are very common benign tumors of the female reproductive tract. According to recent reports, magnetic resonance-guided high-intensity ultrasound (MR-HIFU) appears to be a well-tolerated and efficient treatment option for UFs. However, MR-HIFU still presents several limitations. The treatment is rarely associated with achieving complete non-perfused volume (NPV). Not all patients are qualified for a final procedure, and selected women obtain very good results in such treatment. The primary objective of this experimental study was to assess the effect of transvaginal misoprostol and intravenous oxytocin preparation on UF volume change, sonication time and NPV after MR-HIFU procedure in women of reproductive age with symptomatic UFs. Secondary outcomes included the effect on the peri-procedural effectiveness of misoprostol and oxytocin. This study enrolled 247 women with symptomatic UFs; based on gynecologic examinations and magnetic resonance imaging (MRI) scans, 128 women qualified for MR-HIFU without pharmacologic treatment, 57 women qualified for the misoprostol/diclofenac group and 62 women qualified for the oxytocin group. Pharmacologic pre-treatment improved NPV compared with non-pharmacologic treatment (average NPV: controls 61.9% ± 25.8%; oxytocin 76.8% ± 20.7%; misoprostol/diclofenac 85.2% ± 15.1%; average sonication time: controls 120 min ± 56.4%; oxytocin 111 min ± 45.4%; misoprostol/diclofenac 80 min ± 47.7%). Statistical analysis did not reveal significant intergroup differences in UF volume changes after 6 mo (controls: n = 40, 37.4% ± 27.5%; oxytocin n = 25, 45.8% ± 31%; misoprostol/diclofenac n = 19, 33.4% ± 23.2%). The misoprostol/diclofenac group, which achieved the highest NPV immediately after the MR-HIFU procedure, was characterized by the lowest UF volume change percentages 6 mo later. The administration of vasoconstrictor drugs (oxytocin and misoprostol/diclofenac) to support MR-HIFU in UF treatment is a new issue that may improve the total effectiveness of this method. Randomized controlled trials are necessary to estimate the real effect of vasoconstrictors on MR-HIFU.


Assuntos
Diclofenaco/administração & dosagem , Ablação por Ultrassom Focalizado de Alta Intensidade/métodos , Leiomioma/tratamento farmacológico , Leiomioma/cirurgia , Imagem por Ressonância Magnética Intervencionista , Misoprostol/administração & dosagem , Ocitocina/administração & dosagem , Cirurgia Assistida por Computador , Neoplasias Uterinas/tratamento farmacológico , Neoplasias Uterinas/cirurgia , Adulto , Estudos de Coortes , Terapia Combinada , Combinação de Medicamentos , Feminino , Humanos , Período Pré-Operatório , Estudos Prospectivos , Adulto Jovem
20.
Acta Obstet Gynecol Scand ; 100(8): 1463-1477, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33768520

RESUMO

INTRODUCTION: Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. MATERIAL AND METHODS: In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n = 744) or transvaginal balloon catheter (n = 469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24 h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. RESULTS: Vaginal delivery within 24 h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8 h (95% CI 1.3-6.2 h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. CONCLUSIONS: Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24 h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.


Assuntos
Maturidade Cervical , Trabalho de Parto Induzido , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Cuidado Pré-Natal , Adulto , Cateteres/efeitos adversos , Feminino , Idade Gestacional , Humanos , Gravidez , Resultado da Gravidez , Inquéritos e Questionários , Suécia
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