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1.
PLoS Med ; 20(12): e1004323, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38153958

RESUMEN

BACKGROUND: Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia. METHODS AND FINDINGS: This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. CONCLUSIONS: Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. TRIAL REGISTRATION: The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).


Asunto(s)
Analgesia , Leiomioma , Propofol , Miomectomía Uterina , Neoplasias Uterinas , Humanos , Femenino , Persona de Mediana Edad , Adolescente , Miomectomía Uterina/efectos adversos , Miomectomía Uterina/métodos , Neoplasias Uterinas/cirugía , Neoplasias Uterinas/complicaciones , Propofol/efectos adversos , Calidad de Vida , Leiomioma/cirugía , Anestesia General/efectos adversos , Dolor/etiología
2.
Acta Obstet Gynecol Scand ; 100(7): 1258-1264, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33454970

RESUMEN

INTRODUCTION: The aim of this study is to evaluate the quality of the endometrial sample obtained by office endometrial aspiration when performed before or after saline contrast sonohysterography (SCSH) in women with postmenopausal bleeding and a thickened endometrium. To conduct a complete, minimally invasive and cost-effective diagnostic workup in women with postmenopausal bleeding and a thickened endometrium, ideally both the office endometrial sampling and SCSH are performed. However, it is not known whether both tests affect each other when performed one after another. MATERIAL AND METHODS: Women with postmenopausal bleeding and an endometrial thickness >4 mm were eligible. Women were randomized into two groups: one group received endometrial aspiration before SCSH, the other group received SCSH before endometrial aspiration. The primary outcome was the proportion of sufficient endometrial samples. Reliability of the SCSH images and pain during procedures were secondary outcomes. RESULTS: During the inclusion period, 513 eligible women with postmenopausal bleeding visited the participating hospitals, 293 of whom received information about the study. Of these women, 232 (79%) agreed to participate. In the SCSH-aspiration group, 65 women (59%) had a sufficient endometrial sample compared with 70 (67%) in the aspiration-SCSH group (odds ratio 1.46, 95% CI 0.83-2.54, P = .19). The proportion of reliable sonographic images was significantly higher in the SCSH-aspiration group (n = 88, 87%) compared with the aspiration-SCSH group (n = 71, 74%) (OR 2.38, 95% CI 1.38-4.99, P = .02) in the per protocol analysis. CONCLUSIONS: This study shows that the quality of an endometrial sample in women with postmenopausal bleeding is not affected by SCSH. Both procedures can be performed in one outpatient visit to perform an optimal diagnostic workup.


Asunto(s)
Hiperplasia Endometrial/diagnóstico por imagen , Endometrio/diagnóstico por imagen , Hemorragia Uterina/diagnóstico por imagen , Neoplasias Uterinas/diagnóstico por imagen , Hiperplasia Endometrial/patología , Endometrio/patología , Femenino , Humanos , Persona de Mediana Edad , Reproducibilidad de los Resultados , Cloruro de Sodio , Hemorragia Uterina/patología
3.
Am J Perinatol ; 32(12): 1151-7, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-25915138

RESUMEN

OBJECTIVE: Cervical length (CL) is associated with the risk of preterm birth (PTB) in multiple pregnancies. However, the position of CL within the pathophysiological pathway of PTB is unclear, and it is unknown which factors are predictive for CL. This study aims to investigate whether in twin pregnancies baseline maternal and obstetrical characteristics are potential indicators for CL, to improve insight in the pathophysiological pathway of PTB. STUDY DESIGN: Secondary analysis of data on twin pregnancies and CL measurement between 16 and 22 weeks. A set of 10 potential indicators, known to be associated with an increased risk of PTB and/or which have a plausible mechanism resulting in a change of CL were selected. We used multivariable linear regression with backward selection to identify independent indicators for CL. RESULTS: A total of 1,447 women with twin pregnancies were included. Mean CL was 43.7 (±8.9) mm. In multivariable analysis, age (0.27 mm/y; 95% confidence interval [CI] 0.16 to 0.39), use of assisted reproductive technologies (ART) (-1.42 mm, 95% CI -2.6 to -0.25), and having delivered at term in a previous pregnancy (1.32 mm, 95% CI 0.25 to 2.39) were significantly associated with CL. CONCLUSION: This study shows that in twin pregnancies, age, use of ART and having delivered term in a previous pregnancy has an association with CL.


Asunto(s)
Medición de Longitud Cervical , Cuello del Útero/diagnóstico por imagen , Embarazo Gemelar/estadística & datos numéricos , Nacimiento Prematuro/epidemiología , Adulto , Femenino , Humanos , Recién Nacido , Modelos Lineales , Tamizaje Masivo , Análisis Multivariante , Países Bajos , Embarazo , Segundo Trimestre del Embarazo , Técnicas Reproductivas Asistidas
4.
J Obstet Gynaecol Can ; 36(4): 309-319, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24798668

RESUMEN

OBJECTIVE: To develop a multivariable prognostic model for the risk of preterm delivery in women with multiple pregnancy that includes cervical length measurement at 16 to 21 weeks' gestation and other variables. METHODS: We used data from a previous randomized trial. We assessed the association between maternal and pregnancy characteristics including cervical length measurement at 16 to 21 weeks' gestation and time to delivery using multivariable Cox regression modelling. Performance of the final model was assessed for the outcomes of preterm and very preterm delivery using calibration and discrimination measures. RESULTS: We studied 507 women, of whom 270 (53%) delivered < 37 weeks (preterm) and 66 (13%) < 32 weeks (very preterm). Women with cervical length < 30 mm delivered more often preterm (hazard ratio 1.9; 95% CI 0.7 to 4.8). Other independently contributing predictors were previous preterm delivery, monochorionicity, smoking, educational level, and triplet pregnancy. Prediction models for preterm and very preterm delivery had a c-index of 0.68 (95% CI 0.63 to 0.72) and 0.68 (95% CI 0.62 to 0.75), respectively, and showed good calibration. CONCLUSION: In women with a multiple pregnancy, the risk of preterm delivery can be assessed with a multivariable model incorporating cervical length and other predictors.


Objectif : Élaborer un modèle pronostique multivarié (comportant la mesure de la longueur cervicale à 16 - 21 semaines de gestation et d'autres variables) pour ce qui est du risque d'accouchement préterme chez les femmes connaissant une grossesse multiple. Méthodes : Nous avons utilisé les données issues d'un essai randomisé précédent. Nous avons évalué l'association entre les caractéristiques maternelles et de grossesse (dont la mesure de la longueur cervicale à 16 - 21 semaines de gestation et le délai avant l'accouchement) au moyen du modèle de régression multivariée de Cox. Le rendement du modèle final a été évalué en fonction de critères d'évaluation traitant du moment de l'accouchement (préterme et très préterme) au moyen de mesures d'étalonnage et de discrimination. Résultats : Nous avons étudié 507 femmes, dont 270 (53 %) ont accouché < 37 semaines (préterme) et 66 (13 %) < 32 semaines (très préterme). Les femmes qui présentaient une longueur cervicale < 30 mm ont plus souvent connu un accouchement préterme (densité de l'incidence, 1,9; IC à 95 %, 0,7 - 4,8). Parmi les autres facteurs prédictifs indépendants, on trouvait les antécédents d'accouchement préterme, la monochorionicité, le tabagisme, le niveau de scolarité et la présence d'une grossesse triple. Les modèles prédictifs pour ce qui est des accouchements préterme et très préterme comptaient un indice C de 0,68 (IC à 95 %, 0,63 - 0,72) et de 0,68 (IC à 95 %, 0,62 - 0,75), respectivement, et présentaient un bon étalonnage. Conclusion : Chez les femmes qui connaissent une grossesse multiple, le risque d'accouchement préterme peut être évalué au moyen d'un modèle multivarié comportant la mesure de la longueur cervicale et d'autres facteurs prédictifs. 


Asunto(s)
Medición de Longitud Cervical , Embarazo Múltiple , Nacimiento Prematuro , Adulto , Escolaridad , Femenino , Edad Gestacional , Humanos , Análisis Multivariante , Embarazo , Fumar/efectos adversos
5.
BMC Pregnancy Childbirth ; 12: 13, 2012 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-22420582

RESUMEN

BACKGROUND: Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix) or to determine adverse effects for rare outcomes such as intrauterine death. METHODS/DESIGN: We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity). Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. DISCUSSION: Combining individual patient data from different randomized trials has potential to provide valuable, clinically useful information regarding the benefits and potential harms of progestogens in women with twin pregnancy overall and in relevant subgroups.


Asunto(s)
Complicaciones del Embarazo/prevención & control , Resultado del Embarazo , Embarazo Gemelar/efectos de los fármacos , Nacimiento Prematuro/prevención & control , Progestinas/uso terapéutico , Adulto , Protocolos Clínicos , Femenino , Humanos , Recién Nacido , Modelos Estadísticos , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto
6.
J Womens Health (Larchmt) ; 31(2): 219-230, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34077695

RESUMEN

Background: Endometriosis stage is not directly related to the burden of symptoms, and recurrence of symptoms occurs frequently. It is suggested that symptoms are associated with psychological distress, as in depression and anxiety disorders. Our aim was to explore the strength of the associations between endometriosis and depression or anxiety and to review correlating factors. Materials and Methods: A literature search was carried out using the electronic databases Embase, PubMed, Web-of-science, and PsycINFO. Search terms related to depression, anxiety, and endometriosis were combined resulting in 1,837 records. Articles were included when describing an association between patients with endometriosis and symptoms of depression or anxiety assessed by validated tools, structured psychiatric interviews, or a documented diagnosis. With 47 articles a systematic qualitative review was performed. Seventeen studies were eligible for meta-analysis. Results: Endometriosis patients experienced significantly more symptoms of depression (standardized mean difference [SMD] of 0.71 (95% confidence interval [CI] 0.36-1.06)) and anxiety (SMD 0.60 (95% CI 0.35-0.84)) compared with healthy controls, but no differences were found comparing endometriosis patients with other chronic pelvic pain patients (SMD -0.01 [95% CI -0.17 to 0.15] for depression and SMD -0.02 [95% CI -0.22 to 0.18] for anxiety). Besides the effect of pain, other correlating factors included age, quality of life, quality of sleep, fatigue, sexual function, gastrointestinal symptoms, comorbidity, self-esteem, emotional self-efficacy, coping style, social adjustment, pain imagery, and pain sensitization. Conclusion: This systematic review supports the assumption that symptoms of depression and anxiety occur frequently in endometriosis patients and are related to chronic pain. Correlating factors should further be investigated.


Asunto(s)
Depresión , Endometriosis , Ansiedad/epidemiología , Trastornos de Ansiedad , Depresión/epidemiología , Endometriosis/complicaciones , Endometriosis/epidemiología , Femenino , Humanos , Calidad de Vida
7.
BMJ Open ; 11(9): e053066, 2021 09 21.
Artículo en Inglés | MEDLINE | ID: mdl-34548367

RESUMEN

INTRODUCTION: Preterm birth is one of the main problems in obstetrics, and the most important cause of neonatal mortality, morbidity and neurodevelopmental impairment. Multiple gestation is an important risk factor for preterm birth, with up to 50% delivering before 37 weeks. Progesterone has a role in maintaining pregnancy and is frequently prescribed to prevent (recurrent) preterm birth and improve pregnancy outcomes in high-risk patients. However, little is known about its long-term effects in multiple gestations. The objective of this follow-up study is to assess long-term benefits and harms of prenatal exposure to progesterone treatment in multiple gestations on child development. METHODS AND ANALYSIS: This is a follow-up study of a multicentre, double-blind, placebo-controlled randomised trial (AMPHIA trial, ISRCTN40512715). Between 2006 and 2009 women with a multiple gestation were randomised at 16-20 weeks of gestation to weekly injections 250 mg 17α-hydroxyprogesterone caproate or placebo, until 36 weeks of gestation or delivery. The current long-term follow-up will assess all children (n=1355) born to mothers who participated in the AMPHIA trial, at 11-14 years of age, with internationally validated questionnaires, completed by themselves, their parents and their teachers. MAIN OUTCOMES ARE CHILD COGNITION AND BEHAVIOUR: Additional outcomes are death (perinatal and up to age 14), gender identity, educational performance and health-related problems. We will use intention-to-treat analyses comparing experimental and placebo group. To adjust for the correlation between twins, general linear mixed-effects models will be used. ETHICS AND DISSEMINATION: Amsterdam UMC MEC provided a waiver for the Medical Research Involving Human Subjects Act (W20_234#20.268). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders, patients and participants. This protocol is published before analysis of the results. TRIAL REGISTRATION NUMBER: NL8933.


Asunto(s)
Nacimiento Prematuro , Adolescente , Femenino , Estudios de Seguimiento , Identidad de Género , Humanos , Recién Nacido , Masculino , Estudios Multicéntricos como Asunto , Embarazo , Embarazo Múltiple , Nacimiento Prematuro/prevención & control , Progesterona , Ensayos Clínicos Controlados Aleatorios como Asunto
8.
Am J Perinatol ; 27(3): 241-9, 2010 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19823963

RESUMEN

Progesterone treatment has proven to be effective in preventing recurrent preterm birth. The use of progesterone varies widely between different obstetric clinics in the Netherlands. The study aimed to identify factors that hamper or facilitate the use of progesterone to create an implementation strategy. A Web-based survey was developed containing questions on sociopolitical factors, organizational factors, knowledge, and attitude. This survey was spread among 212 gynecologists, 203 midwives, and 130 women with a recent preterm birth. Response rates were 46% for gynecologists, 57% for midwives, and 78% for patients. Twenty-five percent of gynecologists were prescribing progesterone, 21% of midwives would recommend progesterone, and 54% of patients were willing to undergo treatment in future pregnancies. Specific factors hampering implementation for gynecologists were working in nonteaching hospitals and absence of progesterone treatment in local protocols. For midwives and patients, unfamiliarity with progesterone was the most notable finding. The major reason for failure of implementation of progesterone treatment to prevent recurrent preterm birth is absence of this treatment in protocols and lack of familiarity with this treatment in midwives and patients. This may be overcome through adjustment of clinical protocols on regional and national levels.


Asunto(s)
Actitud del Personal de Salud , Resultado del Embarazo/epidemiología , Nacimiento Prematuro/tratamiento farmacológico , Progesterona/administración & dosificación , Progestinas/administración & dosificación , Adulto , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Países Bajos , Obstetricia/normas , Embarazo , Embarazo de Alto Riesgo , Nacimiento Prematuro/prevención & control , Atención Prenatal/métodos , Prevención Secundaria , Encuestas y Cuestionarios , Resultado del Tratamiento , Adulto Joven
9.
Sex Med ; 8(3): 532-544, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32712127

RESUMEN

INTRODUCTION: Endometriosis is a benign gynecological disease with a high disease burden and significant, multifaceted impact on health-related quality of life (HRQoL) and sexual quality of life (SQoL). AIM: To explore which patient- and disease-specific characteristics were independently associated with SQoL. METHODS: A literature search was carried out to identify characteristics with an evidence-based or hypothesized effect on SQoL. Subsequently, data on HRQoL in women with endometriosis (n = 224), collected between 2013 and 2018 in a prospective longitudinal Dutch cohort study performed in 7 referral centers, were used to perform a cross-sectional cohort study. Data were collected using an online self-administered survey including the validated Endometriosis Health Profile-30. Inclusion criteria were recently diagnosed endometriosis patients or newly referred patients with a clinical diagnosis of endometriosis. Patients were excluded in case of incomplete answers on the SQoL questions. Univariate analyses and multiple linear regression analyses were performed. OUTCOMES: SQoL, measured by the 5-item "sexual intercourse" dimension score of the modular Endometriosis Health Profile-30 questionnaire, was the primary outcome with scores ranging from 0 to 100 (0 indicating the best and 100 indicating the worst health status). RESULTS: Based on a literature search, 29 characteristics potentially associated with SQoL were selected from the survey and included in the analyses. In total, 192 women (mean age 36 years) met the inclusion criteria. The majority of women (86.5%) had had intercourse in the period before completing the survey and the study population showed a mean SQoL score of 47.5 ± 29.6, indicating moderate SQoL. Worse SQoL was independently associated with dyspareunia (P < .001), worse HRQoL (P = .001), severity of dysmenorrhea (P = .017), and unemployed work status (P = .022). CONCLUSION: In a cohort of women with endometriosis, worse SQoL was significantly and independently associated with the presence of dyspareunia, more severe dysmenorrhea, worse HRQoL, and unemployed work status. van Poll M, van Barneveld E, Aerts L, et al. Endometriosis and Sexual Quality of Life. Sex Med 2020;8:532-544.

10.
BMC Pregnancy Childbirth ; 9: 44, 2009 Sep 17.
Artículo en Inglés | MEDLINE | ID: mdl-19761606

RESUMEN

BACKGROUND: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. METHODS/DESIGN: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80. DISCUSSION: This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies. TRIAL REGISTRATION: Current Controlled Trials: NTR 1858.


Asunto(s)
Embarazo Múltiple , Nacimiento Prematuro/prevención & control , Medición de Longitud Cervical , Protocolos Clínicos , Análisis Costo-Beneficio , Femenino , Humanos , Países Bajos , Evaluación de Resultado en la Atención de Salud , Pesarios/economía , Embarazo , Segundo Trimestre del Embarazo , Proyectos de Investigación , Resultado del Tratamiento , Gemelos
11.
BMC Pregnancy Childbirth ; 7: 7, 2007 Jun 19.
Artículo en Inglés | MEDLINE | ID: mdl-17578562

RESUMEN

BACKGROUND: 15% of multiple pregnancies ends in a preterm delivery, which can lead to mortality and severe long term neonatal morbidity. At present, no generally accepted strategy for the prevention of preterm birth in multiple pregnancies exists. Prophylactic administration of 17-alpha hydroxyprogesterone caproate (17OHPC) has proven to be effective in the prevention of preterm birth in women with singleton pregnancies with a previous preterm delivery. At present, there are no data on the effectiveness of progesterone in the prevention of preterm birth in multiple pregnancies. METHODS/DESIGN: We aim to investigate the hypothesis that 17OHPC will reduce the incidence of the composite neonatal morbidity of neonates by reducing the early preterm birth rate in multiple pregnancies. Women with a multiple pregnancy at a gestational age between 15 and 20 weeks of gestation will be entered in a placebo-controlled, double blinded randomised study comparing weekly 250 mg 17OHPC intramuscular injections from 16-20 weeks up to 36 weeks of gestation versus placebo. At study entry, cervical length will be measured. The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 15% to 8%. Analysis will be by intention to treat. We will also analyse whether the treatment effect is dependent on cervical length. DISCUSSION: This trial will provide evidence as to whether or not 17OHPC-treatment is an effective means of preventing bad neonatal outcome due to preterm birth in multiple pregnancies. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40512715.


Asunto(s)
Hidroxiprogesteronas/administración & dosificación , Trabajo de Parto Prematuro/prevención & control , Resultado del Embarazo , Embarazo Múltiple , Progestinas/administración & dosificación , Caproato de 17 alfa-Hidroxiprogesterona , Adulto , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Humanos , Recién Nacido , Embarazo , Embarazo de Alto Riesgo , Resultado del Tratamiento
12.
Obstet Gynecol Surv ; 60(9): 613-7, 2005 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-16121116

RESUMEN

UNLABELLED: Management and outcome of 5 cases of pregnancy after uterine rupture are discussed. All women in these cases were delivered by cesarean delivery and no repeat ruptures occurred. After reviewing the literature, it is concluded that women with a previous uterine rupture have a favorable outcome in a subsequent pregnancy. With a rupture in a lower segment scar, an elective cesarean delivery should be performed before labor starts after assessing fetal lung maturity or administration of corticosteroids. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader should be able to describe the risk associated with a subsequent pregnancy after a previous uterine rupture, summarize the complications of uterine rupture during a subsequent pregnancy, and to list the treatment plans for a patient in a subsequent pregnancy after uterine rupture.


Asunto(s)
Cesárea , Rotura Uterina/prevención & control , Adulto , Femenino , Humanos , Embarazo
13.
J Matern Fetal Neonatal Med ; 24(12): 1456-60, 2011 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-21823903

RESUMEN

OBJECTIVE: Treatments that have proven to be effective in large randomized controlled trials are implemented in clinical practice at varying rates. We measured to what extent new and established strategies were applied to prevent recurrent preterm birth in the Netherlands. METHODS: In two academic hospitals, two non-academic teaching hospitals and two non-academic, non-teaching hospitals, we reviewed charts of all women who had delivered in 2006 and at that time had a history of spontaneous preterm birth before 34 weeks. We compared the application of preventive treatments between different types of hospitals. RESULTS: Ninety-one records were identified. In academic centers, screening for bacterial vaginosis and progesterone treatment were applied more often than in other centers (49 vs. 14%, p-value 0.001 and 63 vs. 22%, p-value <0.001, respectively). Cervical length measurement was applied more often in non-academic hospitals (58 vs. 39%, p-value 0.07), but with fewer measurements per patient (average of 3.3 vs. 5.8). CONCLUSION: In the management of women with a history of preterm birth, there is large practice variation. Relatively new treatments such as progesterone injections and screening for bacterial vaginosis are applied more frequently in academic centers, whereas cervical length measurement is more often performed in non-academic hospitals.


Asunto(s)
Práctica Clínica Basada en la Evidencia , Nacimiento Prematuro/prevención & control , Profilaxis Antibiótica/estadística & datos numéricos , Medición de Longitud Cervical/estadística & datos numéricos , Práctica Clínica Basada en la Evidencia/métodos , Femenino , Edad Gestacional , Humanos , Recién Nacido , Embarazo , Nacimiento Prematuro/epidemiología , Diagnóstico Prenatal/métodos , Diagnóstico Prenatal/estadística & datos numéricos , Práctica Profesional/estadística & datos numéricos , Historia Reproductiva , Estudios Retrospectivos , Prevención Secundaria , Vaginosis Bacteriana/complicaciones , Vaginosis Bacteriana/tratamiento farmacológico , Vaginosis Bacteriana/epidemiología
14.
Obstet Gynecol ; 118(3): 513-520, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21860279

RESUMEN

OBJECTIVE: To estimate whether administration of 17α-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate. METHODS: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17α-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation. RESULTS: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17α-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17α-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P=.32). Treatment with 17α-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17α-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28). CONCLUSION: 17α-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.isrctn.org, ISRCTN40512715.


Asunto(s)
Hidroxiprogesteronas/uso terapéutico , Nacimiento Prematuro/prevención & control , Congéneres de la Progesterona/uso terapéutico , Caproato de 17 alfa-Hidroxiprogesterona , Adulto , Cuello del Útero/anatomía & histología , Método Doble Ciego , Femenino , Edad Gestacional , Humanos , Inyecciones Intramusculares , Análisis de Intención de Tratar , Embarazo , Resultado del Embarazo , Segundo Trimestre del Embarazo , Embarazo Múltiple
15.
Ned Tijdschr Geneeskd ; 154: A1730, 2010.
Artículo en Holandés | MEDLINE | ID: mdl-20858311

RESUMEN

Since the discovery of progesterone researchers have studied whether administration of exogenous progesterone can prevent preterm birth. Two trials were published in 2003 that showed a positive effect of progesterone with regard to the prevention of recurrent preterm birth. However, more recent data do not support these findings. In multiple pregnancies the use of progesterone does not seem to reduce the number of preterm births. The results in pregnant women with asymptomatic shortening of the cervix are promising, although more research is needed in this group.


Asunto(s)
Trabajo de Parto Prematuro/prevención & control , Progesterona/administración & dosificación , Progestinas/administración & dosificación , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Embarazo , Nacimiento Prematuro/prevención & control , Resultado del Tratamiento
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