RESUMO
Objective: To investigate differences in continuation rates between contraceptive and therapeutic use of the levonorgestrel-releasing intrauterine system 52 mg (LNG-IUS) and factors associated with early removal.Methods: Study design: Retrospective consecutive cohort design.Cohort: Women with the insertion of the LNG-IUS for contraceptive or therapeutic use from 1 January 2006 through 1 January 2009 at the Zuyderland Medical Centre, The Netherlands, with a follow-up of 5 years. The continuation period and reasons of early removal were noted. Univariable and multivariable analysis were performed.Results: Follow-up was possible in 2481 women, 1855 (74.8%) in the contraception group, and 626 (25.2%) in the therapy group. Multivariable Cox proportional hazards models showed, that therapeutic use was associated with an increased risk of early removal of the LNG-IUS (HR 1.23; 95% CI 1.08-1.41), as was having one child (HR 1.20; 95% CI 1.04-1.38), and a decreased risk with advancing age (HR 0.96; 95% CI 0.95-0.97). In both groups, an unacceptable bleeding pattern and adverse events were the main reasons of early removal, resulting in very low continuation rates over the years.Conclusion: Therapeutic use, having one child and a younger age are independent risk factors of early removal of the LNG-IUS, in contrast with previous LNG-IUS use which is associated with a lower risk. In both the contraception group and the therapy group, the main reasons for LNG-IUS discontinuation are continuation with a new LNG-IUS, and no more need for an LNG-IUS (for contraception or therapy). An unacceptable bleeding pattern or adverse events are associated with the lowest continuation rates in both groups.
Assuntos
Anticoncepcionais Femininos/uso terapêutico , Dispositivos Intrauterinos Medicados/efeitos adversos , Dispositivos Intrauterinos Medicados/estatística & dados numéricos , Levanogestrel/uso terapêutico , Adulto , Fatores Etários , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/efeitos adversos , Características da Família , Feminino , Humanos , Levanogestrel/administração & dosagem , Levanogestrel/efeitos adversos , Estudos Longitudinais , Países Baixos , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Hemorragia Uterina/induzido quimicamenteRESUMO
BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 µg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FUNDING: FondsNutsOhra.
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Cateterismo/métodos , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Administração Oral , Adulto , Índice de Apgar , Asfixia Neonatal/etiologia , Cateterismo/efeitos adversos , Maturidade Cervical/efeitos dos fármacos , Parto Obstétrico/métodos , Esquema de Medicação , Feminino , Humanos , Recém-Nascido , Trabalho de Parto Induzido/efeitos adversos , Misoprostol/efeitos adversos , Ocitócicos/efeitos adversos , Hemorragia Pós-Parto/etiologia , Gravidez , Nascimento a Termo , Cateterismo Urinário/instrumentaçãoRESUMO
Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p = 0.02). Conclusion Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions.
Assuntos
Cateterismo , Trabalho de Parto Induzido/métodos , Misoprostol/uso terapêutico , Ocitócicos , Preferência do Paciente/estatística & dados numéricos , Administração Oral , Adulto , Medo , Feminino , Humanos , Controle Interno-Externo , Trabalho de Parto Induzido/psicologia , Trabalho de Parto , Misoprostol/administração & dosagem , Dor/etiologia , Gravidez , Distribuição Aleatória , Inquéritos e Questionários , Nascimento a Termo , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVES: To evaluate the effect of androgen supplementation in healthy combined oral contraceptive (COC) users who experience mood disturbances during COC-use only. METHODS: Six women with mood disturbances during COC-use only, received COC with co-treatment of 50 mg dehydroepiandrosterone (DHEA) during three cycles and placebo during another three cycles in an individualized random order. Daily mood rating was measured by a single item: 'In what kind of mood have you been in the past 24 h?' The results were analysed using a randomisation test for single-case experimental designs. RESULTS: The p values for the alternation design randomisation tests on the raw data of the six healthy individuals varied between 0.21 and 1, indicating that the average daily mood ratings of the active treatment DHEA are not statistically significantly larger than the average daily mood ratings of placebo. The combined p value of the subjects using a DRSP-containing pill was 0.97, and of the subjects using an LNG-containing pill was 0.65, indicating no statistically significant treatment effect for any of the pill types. CONCLUSIONS: In this single-case alternation design study, concomitant treatment with DHEA for intermittent periods of 4 weeks did not result in improvement of mood disturbances related to COC-use, but had also no side-effects.
Assuntos
Afeto/efeitos dos fármacos , Androstenos/administração & dosagem , Anticoncepcionais Orais Combinados/administração & dosagem , Desidroepiandrosterona/administração & dosagem , Transtornos do Humor/prevenção & controle , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Projetos Piloto , Qualidade de VidaRESUMO
INTRODUCTION: We investigated the predictive capacity of mid-trimester cervical length (CL) measurement for spontaneous and iatrogenic preterm birth. MATERIAL AND METHODS: We performed a prospective observational cohort study in nulliparous women and low-risk multiparous women with a singleton pregnancy between 16(+0) and 21(+6) weeks of gestation. We assessed the prognostic capacity of transvaginally measured mid-trimester CL for spontaneous and iatrogenic preterm birth (<37 weeks) using likelihood ratios (LR) and receiver-operating-characteristic analysis. We calculated numbers needed to screen to prevent one preterm birth assuming different treatment effects. Main outcome measures were preterm birth <32, <34 and <37 weeks. RESULTS: We studied 11,943 women, of whom 666 (5.6%) delivered preterm: 464 (3.9%) spontaneous and 202 (1.7%) iatrogenic. Mean CL was 44.1 mm (SD 7.8 mm). In nulliparous women, the LRs for spontaneous preterm birth varied between 27 (95% CI 7.7-95) for a CL ≤ 20 mm, and 2.0 (95% CI 1.6-2.5) for a CL between 30 and 35 mm. For low-risk multiparous women, these LRs were 37 (95% CI 7.5-182) and 1.5 (95% CI 0.97-2.2), respectively. Using a cut-off for CL ≤ 30 mm, 28 (6.0%) of 464 women with spontaneous preterm birth were identified. The number needed to screen to prevent one case of preterm birth was 618 in nulliparous women and 1417 for low-risk multiparous women (40% treatment effect, cut-off 30 mm). CONCLUSION: In women at low risk of preterm birth, CL predicts spontaneous preterm birth. However, its isolated use as a screening tool has limited value due to low sensitivity.
Assuntos
Medida do Comprimento Cervical , Colo do Útero/diagnóstico por imagem , Nascimento Prematuro/diagnóstico , Nascimento Prematuro/epidemiologia , Adulto , Estudos de Coortes , Feminino , Humanos , Funções Verossimilhança , Países Baixos/epidemiologia , Tamanho do Órgão , Paridade , Gravidez , Segundo Trimestre da Gravidez , Prognóstico , Curva ROCAssuntos
Saúde Reprodutiva/educação , Saúde Sexual/educação , Anticoncepção , Currículo , Humanos , Reprodução , Comportamento SexualRESUMO
OBJECTIVES To investigate the continuation rates of the etonogestrel subdermal contraceptive implant among well-informed women, and the reasons for early discontinuation. STUDY DESIGN Retrospective consecutive cohort design. METHODS Women who had the implant inserted between 1 January 2006 and 1 January 2010 at the Atrium Medical Centre, the Netherlands were followed up for at least three years. The dates of insertion and removal were recorded, as were the reasons for removal. Statistical analysis was performed using the independent samples t-test and the Pearson alpha correlation test. RESULTS The implant was inserted in 230 women. Follow-up was possible in 214 women, with an average age of 26.7 years. Most of them were nulliparous and the majority had used a combined oral contraceptive, Implanon®, or Mirena® previously. The mean overall continuation period was 23.5 months (95% confidence interval: 21.7-25.3), with a median of 25 months. The continuation rate after 12 months was 72%; after 24 months, 53%; and after 36 months, 25%, with all women concerned having a new implant placed. The previously used contraceptive method Implanon® was associated with the highest continuation rates. An erratic bleeding pattern was the main reason for early removal. CONCLUSIONS Despite adequate counselling before insertion, the continuation rate of the etonogestrel implant was rather low compared to those reported by other investigators. The main reason for discontinuation was an irregular bleeding pattern.
Assuntos
Anticoncepcionais Femininos/uso terapêutico , Desogestrel/uso terapêutico , Implantes de Medicamento/uso terapêutico , Metrorragia/induzido quimicamente , Adolescente , Adulto , Estudos de Coortes , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Países Baixos , Paridade , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) compared induction of labor and expectant management in suspected intrauterine growth restriction (IUGR) at term. In this subanalysis, we report neonatal morbidity between the policies based on the Morbidity Assessment Index for Newborns (MAIN). STUDY DESIGN: We used data from the DIGITAT. For each neonate, we calculated the MAIN score, a validated outcome scale. RESULTS: There were no differences in mean MAIN scores or in MAIN morbidity categories. We found that neonatal admissions are lower after 38 weeks' gestational age compared with 36 and 37 weeks in both groups. CONCLUSION: The incidence of neonatal morbidity in IUGR at term is comparable and relatively mild either after induction or after an expectant policy. However, neonatal admissions are lower after 38 weeks of pregnancy, so if induction to preempt possible stillbirth is considered, it is reasonable to delay until 38 weeks, provided watchful monitoring.
Assuntos
Retardo do Crescimento Fetal/epidemiologia , Trabalho de Parto Induzido/estatística & dados numéricos , Resultado da Gravidez/epidemiologia , Conduta Expectante/estatística & dados numéricos , Adulto , Feminino , Idade Gestacional , Humanos , Incidência , Recém-Nascido , Morbidade , Gravidez , Estudos Prospectivos , Adulto JovemRESUMO
OBJECTIVE: We sought to study long-term (neuro)developmental and behavioral outcome of pregnancies complicated by intrauterine growth restriction at term in relation to induction of labor or an expectant management. STUDY DESIGN: Parents of 2-year-old children included in the Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) answered the Ages and Stages Questionnaire (ASQ) and Child Behavior Checklist (CBCL). RESULTS: We approached 582 (89.5%) of 650 parents. The response rate was 50%. Of these children, 27% had an abnormal score on the ASQ and 13% on the CBCL. Results of the ASQ and the CBCL for the 2 policies were comparable. Low birthweight, positive Morbidity Assessment Index score, and admission to intermediate care increased the risk of an abnormal outcome of the ASQ. This effect was not seen for the CBCL. CONCLUSION: In women with intrauterine growth restriction at term, neither a policy of induction of labor nor expectant management affect developmental and behavioral outcome when compared to expectant management.
Assuntos
Transtornos do Comportamento Infantil/etiologia , Deficiências do Desenvolvimento/etiologia , Retardo do Crescimento Fetal , Trabalho de Parto Induzido , Conduta Expectante , Adulto , Transtornos do Comportamento Infantil/diagnóstico , Pré-Escolar , Deficiências do Desenvolvimento/diagnóstico , Feminino , Seguimentos , Humanos , Modelos Logísticos , Gravidez , Inquéritos e Questionários , Nascimento a TermoRESUMO
INTRODUCTION AND HYPOTHESIS: This study aimed to determine the relationship of recurrent cystocele with avulsion of puborectalis muscle and other risk factors. METHODS: In this prospective observational cohort study, 245 women undergoing anterior colporrhaphy were invited for a 2-year follow-up visit consisting of a questionnaire, physical examination, and translabial 3D ultrasonography. Women with and without recurrent cystocele were compared to identify recurrence risk factors. RESULTS: Of the 245 women, 156 agreed to the follow-up visit (63.7%). Objective recurrence rate was 80 of 156 (51.3%). Seventeen of the 156 (10.9%) reported subjective recurrence. Risk factors for anatomical recurrence were complete avulsion of puborectalis muscle (OR, 2.4; 95% CI, 1.3, 4.7), advanced preoperative stage (OR, 2.0; 95% CI, 1.0, 4.1), family history of prolapse (OR, 2.4; 95% CI, 1.2, 4.9), and sacrospinous fixation (OR, 6.5; 95% CI, 2.0, 21.2). CONCLUSIONS: Risk factors for anatomical cystocele recurrence after anterior colporrhaphy were complete avulsion of puborectalis muscle, advanced preoperative stage, family history of prolapse, and sacrospinous fixation.
Assuntos
Cistocele/cirurgia , Músculo Esquelético/patologia , Vagina/cirurgia , Idoso , Cistocele/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Imageamento Tridimensional , Pessoa de Meia-Idade , Músculo Esquelético/diagnóstico por imagem , Músculo Esquelético/lesões , Estudos Prospectivos , Recidiva , Fatores de Risco , Região Sacrococcígea/cirurgia , Índice de Gravidade de Doença , Método Simples-Cego , Inquéritos e Questionários , UltrassonografiaRESUMO
OBJECTIVES: To review the clinical experience with the contraceptive vaginal ring (CVR, NuvaRing(®)) since its introduction over ten years ago. METHODS: The literature was searched on efficacy, cycle control, safety, user preference and satisfaction of the CVR in comparison with combined oral contraceptives (COCs) and the patch, with special attention to recent developments. RESULTS: The ring has the same working mechanism and contraindications as COCs. Serum levels of steroids are steadier, whereas oestrogenic exposure is lower. Contraceptive efficacy is similar, as are metabolic changes. Cycle control is better, and compliance and continuation rates are equal or higher. Oestrogen-related adverse symptoms appear to be fewer, but reports on the incidence of venous thrombosis are conflicting. Expulsion of the ring is reported by 4% to 20% of women. Local adverse events are the main reason for discontinuation. Acceptability is as high as with COCs and, after structured counselling, the ring is preferred by many women to the pill or the patch. CONCLUSIONS: Efficacy of the CVR, and the metabolic changes and adverse events it elicits, are generally comparable to those of COCs, yet oestrogenic exposure is lower and cycle control superior. After counselling, the ring is preferred to the pill by many women.
Assuntos
Comportamento Contraceptivo , Anticoncepcionais/farmacologia , Dispositivos Anticoncepcionais Femininos/tendências , Anticoncepcionais Orais Combinados/farmacologia , Desogestrel/análogos & derivados , Etinilestradiol/uso terapêutico , Administração Intravaginal , Anticoncepcionais/efeitos adversos , Anticoncepcionais/farmacocinética , Anticoncepcionais Orais Combinados/efeitos adversos , Anticoncepcionais Orais Combinados/farmacocinética , Desogestrel/efeitos adversos , Desogestrel/farmacocinética , Desogestrel/uso terapêutico , Relação Dose-Resposta a Droga , Combinação de Medicamentos , Estrogênios/metabolismo , Etinilestradiol/efeitos adversos , Etinilestradiol/farmacocinética , Feminino , Humanos , Ciclo Menstrual/efeitos dos fármacos , Aceitação pelo Paciente de Cuidados de Saúde , Adesivo Transdérmico , Resultado do TratamentoRESUMO
INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the number of temporary catheter replacements and urinary tract infections after indwelling catheterization for 2 versus 5 days following an anterior colporrhaphy. METHODS: Two hundred forty-six patients were randomly assigned to 2 or 5 days of indwelling catheterization. Outcome measures were temporary catheter replacements because of post-voiding residual >200 mL after removal of the indwelling catheter, urinary tract infections, and hospital stay. All patients were analyzed according to the intention to treat principle. RESULTS: Compared to the 5-day protocol group, in the 2-day protocol group more patients needed temporary catheter replacement (9% versus 28%, odds ratio (OR) 4.0, confidence interval (CI) 1.9-8.3, p < 0.01), whereas less patients had a urinary tract infection (37% versus 22%, OR 0.5, CI 0.3-0.9, p = 0.02) and median hospital stay was lower. CONCLUSIONS: Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements, but less urinary tract infections and a shorter hospital stay.
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Cateteres de Demora/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Cateterismo Urinário/efeitos adversos , Retenção Urinária/epidemiologia , Infecções Urinárias/epidemiologia , Idoso , Cistocele/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Fatores de Tempo , Retenção Urinária/etiologia , Infecções Urinárias/etiologiaRESUMO
BACKGROUND: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands. METHODS/DESIGN: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%). DISCUSSION: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.
Assuntos
Anemia/terapia , Protocolos Clínicos , Transfusão de Eritrócitos , Qualidade de Vida/psicologia , Projetos de Pesquisa , Anemia/etiologia , Feminino , Humanos , Países Baixos , Hemorragia Pós-Parto , Guias de Prática Clínica como Assunto , GravidezRESUMO
BACKGROUND: The disproportionate intrauterine growth intervention trial at term was an intention to treat analysis and compared labor induction with expectant monitoring in pregnancies complicated by fetal growth restriction at term and showed equivalence for neonatal outcomes. OBJECTIVE: To evaluate trial participation bias and to examine the generalizability of the results of an obstetrical randomized trial. STUDY DESIGN: We used data from participants and nonparticipants of a randomized controlled trial-the disproportionate intrauterine growth intervention trial at term (n=1116) -to perform a secondary analysis. This study compared induction of labor and expectant management in women with term growth restriction. Data were collected in the same manner for both groups. Baseline characteristics and neonatal and maternal outcomes were compared. The primary outcome was a composite measure of adverse neonatal outcome. Secondary outcomes were delivery by cesarean delivery and instrumental vaginal delivery; length of stay in the neonatal intensive care, neonatal ward, and the maternal hospital; and maternal morbidity. RESULTS: Nonparticipants were older, had a lower body mass index, had a higher level of education, smoked less, and preferred expectant management. The time between study inclusion and labor onset was shorter in participants than in nonparticipants. Notably, 4 perinatal deaths occurred among nonparticipants and none among participants. Among nonparticipants, there were more children born with a birthweight below the third centile. The nonparticipants who had expectant management were monitored less frequently than the participants in both the intervention and the expectant arm. CONCLUSION: We found less favorable outcomes and more perinatal deaths in nonparticipants. Protocol-driven management, differences between participants and nonparticipants, or the fact that nonparticipants had a preference for expectant management might explain the findings.
Assuntos
Retardo do Crescimento Fetal , Morte Perinatal , Criança , Feminino , Humanos , Recém-Nascido , Consentimento Livre e Esclarecido , Trabalho de Parto Induzido , Gravidez , Conduta ExpectanteRESUMO
Objective: The aim of this study was to study growth patterns of children born after suspected fetal growth restriction (FGR) at term and to compare the effect of induction of labor (IoL) and expectant management (EM), also in relation to neurodevelopmental and behavioral outcome at age 2. Methods: We performed a 2 years' follow-up of growth of children included in the Disproportionate Intrauterine Growth Restriction Trial at Term (DIGITAT) study, a Randomized Controlled Trial (RCT) comparing IoL with EM in pregnancies with suspected FGR at term. We collected data on child growth until the age of 2 years. Standard deviation scores (SDSs) for height and weight were calculated at different ages. We assessed the effects of IoL compared with EM and the effects of a birth weight below or above the 3rd or 10th centile on catch-up growth. Target height SDSs were calculated using the height of both parents. Results: We found a significant increase in SDS in the first 2 years. Children born after EM showed more catch-up growth in the first month [height: mean difference -0.7 (95% CI: 0.2; 1.3)] and weight [mean difference -0.5 (95% CI: 0.3; 0.7)]. Children born with a birth weight below the 3rd and 10th centiles showed more catch-up growth after 1 year [mean difference -0.8 SDS (95% CI: -1.1; -0.5)] and after 2 years [mean difference -0.7 SDS (95% CI: -1.2; -0.2)] as compared to children with a birth weight above the 3rd and 10th centiles. SDS at birth had the strongest effect on adverse neurodevelopmental outcome at 2 years of age. Conclusion: After FGR at term, postnatal catch-up growth is generally present and associated with the degree of FGR. Obstetric management in FGR influences postnatal growth. Longer-term follow-up is therefore needed and should be directed at growth and physical health. Clinical Trial Registration: www.ClinicalTrials.gov, identifier SRCTN10363217.
RESUMO
OBJECTIVE: To compare, in women with twin pregnancy with the first twin in cephalic position, neonatal morbidity and mortality rates after planned caesarean delivery (CD) versus planned vaginal delivery (VD). STUDY DESIGN: A nationwide cohort study on women pregnant with twins and the first child in cephalic position, who delivered between 32â¯+â¯0-41â¯+â¯0 weeks between 2000 and 2012 in the Netherlands, using multivariate logistic regression analysis to compare neonatal morbidity and mortality according to planned delivery mode, and looking at subgroups 32â¯+â¯0-36â¯+â¯6 and 37â¯+â¯0-41â¯+â¯0 weeks. RESULTS: We included 21,107 women, of whom 1384 (6.6%) had a planned CD. Of the 19,723 women (93.4%) who had a planned VD, 19.7% delivered by intrapartum CD. We found no significant differences in 'any mortality' (aOR planned CD vs. planned VD 1.34 (95% CI 0.63-2.60)), the outcome 'Apgar score (AS)â¯<â¯4 or death within 28â¯days' (aOR 1.28 (95% CI 0.77-2.11) or asphyxia-related morbidity (aOR 0.57 (95% CI 0.32-1.03)). After planned CD more prematurity-related morbidity (aOR 1.55 (95% CI 1.21-1.98)), other morbidity (aOR 1.50 (95% CI 1.26-1.78)) and 'any morbidity or mortality' (aOR 1.41 (95% CI 1.20-1.66) was noted. Trauma-associated morbidity was absent after planned CD and occurred 45 times (0.2%) after planned VD. Before 36â¯+â¯6 weeks, planned CD resulted in more perinatal mortality (aOR 2.10 (95% CI 0.92-4.76)), while asphyxia-related morbidity did not differ (aOR 0.80 (95% CI 0.41-1.54). Planned CD resulted in more 'any morbidity or mortality' (aOR 1.52 (95% CI 1.25-1.84)), 'ASâ¯<â¯4 or death within 28â¯days' (aOR 1.77 (95% CI 1.02-3.09)), prematurity-related morbidity (aOR 1.73 (95% CI 1.34-2.23)), and 'other morbidity' (aOR 1.56 (95% CI 1.28-1.90)). After 37 weeks, no significance differences in mortality, 'any morbidity or mortality <28â¯days' (aOR 0.96 (95% CI 1 (0.67-1.38)), or 'ASâ¯<â¯4 or death within 28â¯days' (aOR 0.41 (95% CI (0.10-1.70)) were found. There was less asphyxia-related morbidity after planned CD (aOR 0.24 (95% CI 0.06-1.002)). CONCLUSION: Planned VD results in comparable neonatal outcomes as planned CD for twin pregnancy with the first twin in cephalic position, even with a low intrapartum CD rate of 19.7%. At term, a planned CD may result in less asphyxia- and trauma-related outcomes.
Assuntos
Cesárea/efeitos adversos , Parto Obstétrico/efeitos adversos , Resultado da Gravidez , Gravidez de Gêmeos , Adulto , Cesárea/mortalidade , Estudos de Coortes , Parto Obstétrico/métodos , Parto Obstétrico/mortalidade , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Países Baixos , Parto , Mortalidade Perinatal , Gravidez , Gêmeos , Adulto JovemRESUMO
BACKGROUND: The purpose of this review was to compare pharmacology, contraceptive efficacy, cycle control, side effects and acceptability with the combined contraceptive vaginal ring (CCVR) and combined oral contraceptives (COCs). STUDY DESIGN: All randomized controlled trials (RCTs) between the CCVR and a COC up to and including December 2006 were analyzed. RESULTS: Twelve RCTs comparing the CCVR and a COC were identified. Systemic exposure to ethinyl estradiol (EE) with the CCVR was half of that with a 30-microg EE-containing COC with less variation in serum levels. During CCVR use, sex hormone-binding globulin and cortisol-binding globulin concentrations were significantly less increased than during COC use. Both methods showed adequate ovarian suppression and equal contraceptive efficacy. Uterine concentrations of EE and etonogestrel were not elevated with the CCVR. Cycle control achieved with the CCVR was better than that of the COC. Compliance with both methods was high. Mean blood pressure and body weight did not change in either group. Incidence of adverse events such as breast tenderness, headache and nausea was comparable, but a higher incidence of local and ring-related events led to higher discontinuation rates in the CCVR group. Both contraceptives were highly acceptable and resulted in a global improvement of sexual function. Ring users were more likely to continue with their method after study completion than COC users. CONCLUSIONS: The vaginal ring has the same contraceptive efficacy as COCs with lower systemic EE exposure, more consistent serum EE levels and better cycle control, but more local adverse events resulting in higher discontinuation rates.
Assuntos
Anticoncepcionais Femininos/administração & dosagem , Dispositivos Anticoncepcionais Femininos , Anticoncepcionais Orais Combinados/administração & dosagem , Anticoncepcionais Orais Combinados/sangue , Feminino , Humanos , Satisfação do Paciente , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to 15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates. METHODS/DESIGN: Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%. DISCUSSION: This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications. TRIAL REGISTRATION: The protocol is registered in the clinical trial register number ISRCTN08132825.
Assuntos
Hipertensão Induzida pela Gravidez/terapia , Trabalho de Parto Induzido/métodos , Pré-Eclâmpsia/terapia , Resultado da Gravidez , Projetos de Pesquisa , Nascimento a Termo , Adulto , Intervalos de Confiança , Feminino , Humanos , Bem-Estar do Lactente , Recém-Nascido , Bem-Estar Materno , Estudos Multicêntricos como Assunto , Gravidez , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. METHODS/DESIGN: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm. DISCUSSION: This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. TRIAL REGISTRATION: Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.