scholarly journals The effectiveness of nifedipine/indomethacin combination therapy and nifedipine monotherapy for postponing preterm birth (25–34 weeks of gestation) in Sudanese women: a randomized clinical trial study protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohammed H. Ibrahim ◽  
Tahani Elfaki ◽  
Elhassan M. Elhassan ◽  
Somia K. Abdelrahiem ◽  
Ishag Adam
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Combination Therapy ◽  
Preterm Labor ◽  
Neonatal Morbidity ◽  
Trial Registration ◽  
Morbidity And Mortality ◽  
Secondary Outcome ◽  
Type I ◽  
First Choice

Abstract Background Preterm birth is the most common cause of neonatal morbidity and mortality. Tocolytics are considered a standard treatment for women with threatened preterm delivery to allow time for maternal steroid administration and transfer to referral centers with neonatal intensive care units. However, there is controversy about the best tocolytic therapy to be considered as the first choice. The aim of this study is to compare the tocolytic effectiveness and tolerability of combination therapy with nifedipine and indomethacin versus nifedipine monotherapy among Sudanese women with preterm labor (PTL) as well as to compare the possible neonatal outcomes associated with each drug. Methods/design This is a randomized controlled clinical trial to be conducted in the Medani Maternity Hospital, Sudan. Women aged 18–40 years that are diagnosed with preterm labor and have a gestational age between 25 and 34 weeks will be eligible to participate in this trial. The diagnosis of threatened PTL is defined as persistent uterine contractions “(four contractions every 20 min or eight contractions every 60 min)” with cervical changes “(cervical effacement ≤80% or cervical dilatation >two cm)”. Patients will be eligible regardless of the presentation of the fetus. It will be randomly decided whether participants receive nifedipine/indomethacin combination therapy or nifedipine monotherapy. The primary outcome is the number of women who do not deliver and do not need alternative tocolytic drug (terbutaline). The secondary outcome is an estimated association with neonatal morbidity and mortality. The sample size will be 117 subjects in each arm of the study, according to a type I error of 0.05 and a study power of 80%. Discussion We expect higher effectiveness of the combination indomethacin/nifedipine tocolytic therapy compared with nifedipine monotherapy. We plan to suggest this combination therapy as the best option for postponing PTL. Trial registration Clinical trial registration: PACTR202004681537890, date of registration: March 8, 2020.

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 A comparative study between nifedipine and isoxsuprine in the suppression of preterm labor pain

2020 ◽  
Vol 9 (7) ◽  
pp. 2886
Author(s):  
Susheela Khoiwal ◽  
Vandana Patidar ◽  
Radha Rastogi ◽  
Bharat Tailor
Keyword(s):  
Preterm Labor ◽  
Preterm Labour ◽  
Neonatal Morbidity ◽  
Labour Pain ◽  
Labor Pain ◽  
Morbidity And Mortality ◽  
Medical College ◽  
Uterine Contractions ◽  
High Incidence ◽  
A Prospective Study

Background: A prospective study was conducted to compare the effectiveness of Nifedipine and Isoxsuprine in suppression of preterm labour pain as tocolytics drug. As preterm labour pain is major contributor for perinatal morbidity and mortality. The aims of this study were to assess the effect of nifedipine and isoxsuprine in threatened preterm labour with the aim of preventing preterm birth and its sequelae.Methods: This study was conducted on 100 patients coming to Pannadhay Rajkiya Mahila Chikitsalaya, RNT Medical College, Udaipur and attending OPD and IPD with complain of uterine contractions between 28-36 weeks of gestation.Results: Nifedipine was more effective than isoxsuprine hydrochloride as tocolytic agent.Conclusions: There is high incidence of preterm labour in India which leads to neonatal morbidity and mortality. Nifedipine is a better tocolytic drug compared to isoxsuprine hydrochloride.

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.

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.

Integrated Review of Cytokines in Maternal, Cord, and Newborn Blood: Part I—Associations With Preterm Birth

2009 ◽  
Vol 11 (4) ◽  
pp. 371-376 ◽  
Author(s):  
Debra Lyon ◽  
Ching-Yu Cheng ◽  
Lois Howland ◽  
Debra Rattican ◽  
Nancy Jallo ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Proinflammatory Cytokines ◽  
Preterm Labor ◽  
Neonatal Morbidity ◽  
The United States ◽  
Fetal Outcome ◽  
Fetal Outcomes ◽  
Consistent Finding ◽  
Mediators Of Inflammation ◽  
Adverse Pregnancy

Preterm birth (PTB; spontaneous delivery prior to 37 weeks gestation) affects one out of eight infants born in the United States and is the most common cause of neonatal morbidity and mortality. Although the pathogenesis of PTB is multifactorial, a growing body of literature supports the hypothesis that one cause of PTB is inflammation in pregnancy. Investigators have implicated mediators of inflammation, most notably proinflammatory cytokines, as being associated with and perhaps a playing a causal role in the pathogenesis of preterm labor and adverse early fetal outcomes. Though researchers have pursued the association of cytokines with preterm labor and subsequent early adverse fetal outcomes as a line of research, there has been little integration of diverse findings across studies. This systematic review appraises the empirical evidence from human studies for the association of levels of cytokines in blood with preterm labor and adverse early fetal outcome to examine the current state of the science in this important area of biobehavioral research. The most consistent finding is that increased levels of proinflammatory cytokines, particularly interleukin (IL) 6, IL-β1, and tumor necrosis factor α (TNF-α), are associated with PTB as compared to levels found at term birth. However, there have been relatively few studies and results have not been consistent. Therefore, further research is needed to elucidate the association of these inflammatory mediators with adverse pregnancy outcomes.

scholarly journals Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Christopher Zaslawski ◽  
Christine Berle ◽  
Marcus Gadau ◽  
Wei Hong Li ◽  
Tie Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hong Kong ◽  
Trial Registration ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Control Group ◽  
Elbow Pain ◽  
Lateral Elbow Pain ◽  
Lateral Elbow ◽  
Randomised Controlled

Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1–3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months’ duration) lateral elbow pain. Four study sites, in the People’s Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013.

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