Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial

Contains fulltext : 79491.pdf (publisher's version ) (Open Access)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

Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p

Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial

Contains fulltext : 53264.pdf (publisher's version ) (Open Access)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

Progesterone for the prevention of preterm birth

In 2003 ontstond na de publicatie van positieve onderzoeksresultaten een hernieuwde internationale interesse voor progesteronbehandeling om vroeggeboorte te voorkomen. De studies die sindsdien bij verschillende risicogroepen zijn uitgevoerd, laten wisselende resultaten zien. Progesteron voorkomt mogelijk vroeggeboortes bij vrouwen met een tijdens de zwangerschap verkorte baarmoedermond, maar heeft geen effect bij meerlingzwangerschappen. Dit laatste toonde Arianne Lim aan in een grote Nederlandse studie. De gunstige resultaten die in de eerste twee trials gezien werden bij vrouwen met een eerdere vroeggeboorte, konden in latere studies niet worden bevestigd. De effectiviteit van progesteron om vroeggeboorte te voorkomen, staat daarom ter discussie en moet verder worden onderzocht

A Study of variables contributing to the successful outcome in the CPA licensure examination of DLSU students who have undergone the traditional or modular accountancy program

The study developed models that could be used in order to predict the performance of DLSU Accountancy students in the CPA licensure examination. It involved 98 students who underwent the traditional program and 63 students who underwent the modular program for a total of 161 respondents. Several factors were considered in the study however, not all appeared to have significant effects. Results show that gender has a negative effect on the overall performance, Practical Accounting 2 and Business Law and Taxation subjects. Having a double degree, higher accounting GPA and Review Module GPA increase the chances of having a better performance in the exam. Moreover, high school GPA also has an effect but not as significant as those previously mentioned. Lastly, it appeared that undergoing the modular program is a huge advantage because it has an impact on four of the seven subjects namely Auditing Theory, Auditing Problems, Management Advisory Services, and Business, Law and Taxation thus, on the overall performance as well

Use of Progesterone Treatment for the Prevention of Recurrent Preterm Birth: Identification of Obstacles to Change

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 level

Endometriosis and Sexual Quality of Life

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 patientand 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. Copyright (c) 2020, The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)