PROLONG Clinical Study Protocol: Hydroxyprogesterone Caproate to Reduce Recurrent Preterm Birth

2018 ◽  
Vol 35 (12) ◽  
pp. 1228-1234 ◽  
Author(s):  
Cynthia Gyamfi-Bannerman ◽  
Joseph Biggio ◽  
Suneet Chauhan ◽  
Brenna Hughes ◽  
Judette Louis ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Sample Size ◽  
Neonatal Morbidity ◽  
Total Sample ◽  
Morbidity And Mortality ◽  
Safety And Efficacy ◽  
Mortality Index ◽  
Hydroxyprogesterone Caproate ◽  
Secondary Outcomes

AbstractThe objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, placebo-controlled, randomized clinical trial (RCT) designed to assess the safety and efficacy of Makena (hydroxyprogesterone caproate injection, 250 mg/mL) in reducing the risk of preterm birth (PTB) and neonatal morbidity/mortality in women pregnant with a singleton gestation who had a previous singleton spontaneous PTB. The total sample size of the RCT will include 1,707 women. The trial has two coprimary outcomes: PTB less than 35 weeks and a composite neonatal morbidity and mortality index. This study sample size will provide 90% power to assess for a 35% reduction in neonatal morbidity and mortality. Secondary outcomes will include 2-year follow-up of infants. The trial is ongoing and targeted to complete recruitment in 2018.

Efficacy of intravitreal conbercept injection in the treatment of retinopathy of prematurity

2018 ◽  
Vol 103 (4) ◽  
pp. 494-498 ◽  
Author(s):  
Yichen Bai ◽  
Huanjie Nie ◽  
Shiyu Wei ◽  
Xiaohe Lu ◽  
Xiaoyun Ke ◽  
...  
Keyword(s):  
Retinopathy Of Prematurity ◽  
Laser Photocoagulation ◽  
Primary Outcome ◽  
Safety And Efficacy ◽  
Postmenstrual Age ◽  
Zone Ii ◽  
The Mean ◽  
Secondary Outcomes ◽  
Number Of Injections

BackgroundTo evaluate the safety and efficacy of intravitreal conbercept (IVC) injection in the treatment of retinopathy of prematurity (ROP).MethodsPatients with ROP who underwent IVC injection in Zhujiang Hospital from June 2015 to July 2016 were studied retrospectively. The primary outcome was defined as the regression of plus disease. The secondary outcomes were defined as the presence of recurrence, number of injections and the final regression of disease.ResultsA total of 48 eyes of 24 patients with ROP were included. Among them, 9 eyes of 5 patients had zone I ROP, 35 eyes of 18 patients had zone II ROP and 4 eyes of 2 patients had aggressive posterior ROP. The mean gestational age was 28.5±1.6 weeks, the mean birth weight was 1209.6±228.6 g, the mean postmenstrual age of first injection was 34.2±1.9 weeks and the mean follow-up period was 31.0±4.7 weeks. Forty of 48 eyes (83.3%) received IVC only once, and the regression of plus disease occurred at an average of 3.5±1.5 weeks after the first injection of conbercept. For eight recurrent eyes (16.7%), four eyes received a second IVC and the remaining four eyes received laser photocoagulation, and the regression of plus disease occurred in 3 weeks. No lens opacity, vitreous haemorrhage, entophthalmia or retinal detachment was observed during follow-up.ConclusionIVC injection is an effective treatment for ROP.

scholarly journals 17-Alpha-Hydroxyprogesterone vs. Placebo for Preventing of Recurrent Preterm Birth: A Systematic Review and Meta-Analysis of Randomized Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Abdulaali R. Almutairi ◽  
Hadir I. Aljohani ◽  
Nouf S. Al-fadel
Keyword(s):  
Systematic Review ◽  
Preterm Birth ◽  
Meta Analysis ◽  
Neonatal Morbidity ◽  
Neonatal Outcomes ◽  
Morbidity And Mortality ◽  
Cochrane Library ◽  
Relative Risk Ratio ◽  
Analysis Model ◽  
Clinical Trial Registries

Background: Preterm birth (PTB) is a leading cause of neonatal morbidity and mortality.Objective: To estimate the effect of 17-alpha-hydroxyprogesterone caproate (17-OHPC) compared to placebo in singleton gestations for reducing the risk of recurrent PTB and neonatal morbidity and mortality.Work Design: Systematic review and meta-analysis.Search Strategy: Searching MEDLINE, Embase, Web of Science, SCOPUS, Cochrane Library, and clinical trial registries.Selection Criteria: Randomized controlled trials of singleton gestations with a history of PTB and treated with a weekly intramuscular injection of 17-OHPC or placebo.Data Collection and Analysis: A random meta-analysis model was performed for the PTB outcomes (<32, <35, and <37 weeks) and neonatal outcomes (neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, and sepsis). Effect estimates were measured by relative risk ratio (RR) with a 95% confidence interval (CI).Main Results: Six works were included. There were no statistically significant reductions in the PTB risk following the use of 17-OHPC at <32 weeks (RR = 0.61, 95% CI: 0.13–2.77, and I2 = 39%), <35weeks (RR = 0.60, 95% CI: 0.10–3.67, and I2 = 51%), and <37 weeks (RR = 0.68, 95% CI: 0.46–1, and I2 = 75%). Furthermore, all the neonatal outcomes were statistically similar between the two groups.Conclusion: Treatment with 17-OHPC is not associated with reducing the risk of PTB or neonatal outcomes compared to placebo.

scholarly journals UMA ANÁLISE INTEGRAL DO TRABALHO DE PARTO PREMATURO

2019 ◽  
Vol 6 (1) ◽  
pp. 54-57
Author(s):  
Renata dos Santos Oliveira ◽  
Maria Luiza Silva Brito ◽  
Delcides Bernardes da Costa Neto
Keyword(s):  
Risk Factors ◽  
Preterm Birth ◽  
Early Diagnosis ◽  
Preterm Labor ◽  
Transvaginal Ultrasound ◽  
Treatment Options ◽  
Neonatal Morbidity ◽  
Morbidity And Mortality ◽  
Fetal Fibronectin ◽  
Appropriate Treatment

A prematuridade é um dos mais significativos desafios da obstetrícia, constituindo a principal causa de morbimortalidade neonatal. A presença de fatores de risco, tanto maternos quanto fetais, geram maior vigilância durante o decorrer da gestação, entretanto cada gravidez ocorre de forma singular e seus fatores devem ser analisados individualmente, motivo que nos leva ao estudo profundo e integral de cada um deles. O diagnóstico do trabalho de parto prematuro é eminentemente clínico e, muitas vezes, de difícil estabelecimento precoce. Para auxiliar na obtenção de um diagnóstico em estágio inicial, tem-se empregado métodos complementares, como o ultrassom transvaginal e a fibronectina fetal. Existem várias opções de tratamento com suas particularidades para a indicação, porém a escolha deve ser feita prontamente a fim de prolongar a gestação, evitando os desfechos desfavoráveis do parto prematuro. Palavras-chave: trabalho de parto prematuro; diagnóstico precoce; tratamento adequado ABSTRACT Prematurity is one of the most significant challenges of obstetrics, being the main cause of neonatal morbidity and mortality. The presence of risk factors, both maternal and fetal, generate greater vigilance during the course of gestation, however each pregnancy occurs in a singular way and its factors must be analyzed individually, reason that leads us to the deep and integral study of each one of them. The diagnosis of preterm labor is eminently clinical and often difficult to establish early. To assist in obtaining an early diagnosis, complementary methods have been employed, such as transvaginal ultrasound and fetal fibronectin. There are several treatment options with their particularities for the indication, but the choice must be made promptly in order to prolong the gestation, avoiding the unfavorable outcomes of the preterm birth. Keywords: preterm labor; early diagnosis; appropriate treatment.

scholarly journals Replication and contradiction of highly cited research papers in psychiatry: 10-year follow-up

2015 ◽  
Vol 207 (4) ◽  
pp. 357-362 ◽  
Author(s):  
Aran Tajika ◽  
Yusuke Ogawa ◽  
Nozomi Takeshima ◽  
Yu Hayasaka ◽  
Toshi A. Furukawa
Keyword(s):  
Sample Size ◽  
Small Sample Size ◽  
Total Sample ◽  
Small Sample ◽  
Research Papers ◽  
Effective Interventions ◽  
Mean Differences ◽  
Larger Sample ◽  
Highly Cited

BackgroundContradictions and initial overestimates are not unusual among highly cited studies. However, this issue has not been researched in psychiatry.AimsTo assess how highly cited studies in psychiatry are replicated by subsequent studies.MethodWe selected highly cited studies claiming effective psychiatric treatments in the years 2000 through 2002. For each of these studies we searched for subsequent studies with a better-controlled design, or with a similar design but a larger sample.ResultsAmong 83 articles recommending effective interventions, 40 had not been subject to any attempt at replication, 16 were contradicted, 11 were found to have substantially smaller effects and only 16 were replicated. The standardised mean differences of the initial studies were overestimated by 132%. Studies with a total sample size of 100 or more tended to produce replicable results.ConclusionsCaution is needed when a study with a small sample size reports a large effect.

scholarly journals The pregnancy microbiome and preterm birth

2020 ◽  
Vol 42 (4) ◽  
pp. 487-499 ◽  
Author(s):  
Erna Bayar ◽  
Phillip R. Bennett ◽  
Denise Chan ◽  
Lynne Sykes ◽  
David A. MacIntyre
Keyword(s):  
Preterm Birth ◽  
Global Health ◽  
Human Microbiome ◽  
Neonatal Morbidity ◽  
Neonatal Care ◽  
Morbidity And Mortality ◽  
Health Concern ◽  
Vaginal Microbiome ◽  
Complex Interplay ◽  
In Pregnancy

Abstract Preterm birth is a global health concern and continues to contribute to substantial neonatal morbidity and mortality despite advances in obstetric and neonatal care. The underlying aetiology is multi-factorial and remains incompletely understood. In this review, the complex interplay between the vaginal microbiome in pregnancy and its association with preterm birth is discussed in depth. Advances in the study of bacteriology and an improved understanding of the human microbiome have seen an improved awareness of the vaginal microbiota in both health and in disease.

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