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Trial of labour

Akihide Konishi, Soichiro Isobe, Daisaku Sato
In Japan, a recent issue that required an urgent response was the streamlining of regulations concerning clinical trials of medical devices. On July 31, 2017, the Ministry of Health, Labour and Welfare enacted a new regulatory framework called the fast-break scheme for innovative medical devices aiming to expedite patient access while reducing the premarket regulatory burden of clinical trials and enhancing postmarketing commitments. The new framework is expected to provide greater benefits to patients who require access to new medical devices and to companies via improved transparency and predictability, as well as to reduce the social and medical cost incurred for medical innovation...
March 13, 2018: Journal of Vascular and Interventional Radiology: JVIR
Adélaïde Compaoré, Sabine Gies, Bernard Brabin, Halidou Tinto, Loretta Brabin
BACKGROUND: Iron deficiency remains a prevalent adolescent health problem in low income countries. Iron supplementation is recommended but improvement of iron status requires good adherence. OBJECTIVES: We explored factors affecting adolescent adherence to weekly iron and/or folic acid supplements in a setting of low secondary school attendance. METHODS: Taped in-depth interviews were conducted with participants in a randomised, controlled, periconceptional iron supplementation trial for young nulliparous women living in a rural, malaria endemic region of Burkina Faso...
March 14, 2018: Reproductive Health
Siddhidatri Mishra, Rashmi Bagga, Jasvinder Kalra, Vanita Jain, Sourabh Dutta
Women (n = 300) at 'low risk' for a preterm birth (PTB), a singleton pregnancy and for a 16-24 week period of gestation (POG) were randomised to undergo cervical length (CL) measurement by transvaginal sonography (TVS) or not. The aim was to see if routine CL measurement and treatment of a short CL reduced the PTB rate. 'Low risk' was defined by an absence of a prior abortion or PTB of a singleton infant (>16 to <37 weeks) due to a spontaneous preterm labour (PTL) or a preterm pre-labour rupture of membranes (pPROM)...
March 14, 2018: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
Javier A Schvartzman, Hugo Krupitzki, Mario Merialdi, Ana Pilar Betrán, Jennifer Requejo, My Huong Nguyen, Effy Vayena, Angel E Fiorillo, Enrique C Gadow, Francisco M Vizcaino, Felicitas von Petery, Victoria Marroquin, María Luisa Cafferata, Agustina Mazzoni, Valerie Vannevel, Robert C Pattinson, A Metin Gülmezoglu, Fernando Althabe, Mercedes Bonet
BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa...
March 12, 2018: Reproductive Health
Maryam Kashanian, Nooshin Eshraghi, Narges Sheikhansari, Arash Bordbar, Elahehsadat Khatami
The purpose of the present study was to compare the effect of a two-dose administration of betamethasone with 12 hours interval vs. 24 hours interval on neonatal respiratory distress syndrome (RDS). The study was performed as a randomised clinical trial on 201 pregnant women with a gestational age of 26-34 weeks. In one group 12 mg of betamethasone every 12 hours for two doses and in the other group 12 mg of betamethasone every 24 hours for two doses were prescribed intramuscularly. There were no significant differences between the two groups according to maternal age, parity, gravidity, BMI, neonatal sex, need to surfactant, NICU admission, NICU stay, neonatal death, neonatal sepsis and Apgar score at minutes 1 and 5, but the gestational age at the beginning of the study and delivery receiving complete course of betamethasone and neonatal weight were lower in 24 hours group...
March 12, 2018: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
Marie-Jocelyne Martel, Catherine Jane MacKinnon
OBJECTIVE: To provide evidence-based guidelines for the provision of a trial of labour (TOL) after Caesarean section. OUTCOME: Fetal and maternal morbidity and mortality associated with vaginal birth after Caesarean (VBAC) and repeat Caesarean section. EVIDENCE: MEDLINE database was searched for articles published from January 1, 1995, to February 28, 2004, using the key words "vaginal birth after Caesarean (Cesarean) section." The quality of evidence is described using the Evaluation of Evidence criteria outlined in the Report of the Canadian Task Force on the Periodic Health Exam...
March 2018: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
Yasmine L Konheim-Kalkstein, Colleen P Kirk, Kristen Berish, Kathleen M Galotti
OBJECTIVE: Our quantitative analysis examined what factors influence pregnant women to choose a vaginal birth after a caesarean (VBAC). BACKGROUND: There is growing concern over the high rates of caesarean section; much of the high rate is driven by repeat caesareans. A trial of labour after a previous caesarean is an option for many women increasingly supported by medical literature. METHODS: Survey data from 173 pregnant women who had had only one birth by caesarean were analysed using a hierarchical binary logistic regression model...
September 2017: Journal of Reproductive and Infant Psychology
Hellen McKinnon Edwards
This thesis is comprised of three studies focusing on severe postpartum haemorrhage (PPH). PPH is a major cause of maternal morbidity and mortality worldwide. Risk factors include retained placenta, prolonged duration of the third stage of labour, previous caesarean section, and operative vaginal delivery. Occurrence and development of PPH are, however, unpredictable and can sometimes give rise to massive haemorrhage or even hysterectomy and maternal death. Severe haemorrhage can lead to coagulopathy causing further haemorrhage and requiring substitution with blood transfusions...
March 2018: Danish Medical Journal
Mila Smithies, Christy G Woolcott, Jo-Ann K Brock, Bryan Maguire, Victoria M Allen
OBJECTIVE: To determine the proportion of women in Robson group 5 (RG5) who were eligible for a trial of labour after Caesarean (TOLAC) and, among eligible candidates, identify determinants of having a TOLAC and subsequent vaginal delivery (VD). METHODS: This population-based cohort study used data derived from the Nova Scotia Atlee Perinatal Database. Deliveries from 1998-2014 to women in RG5 (≥1 previous CS with a singleton term cephalic fetus) were included...
March 1, 2018: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
Sven Kehl
Objective of this randomized-controlled multicenter-trial was to determine whether the amniotic fluid index (AFI) or the single deepest vertical pocket (SDP) technique for estimating amniotic fluid volume is superior for predicting adverse perinatal outcome. Pregnant women at term were randomized in AFI or SDP group for assessing amniotic fluid at four unversitary hospitals. These two groups were not different with regards to primary outcome parameter (rate of postpartum admission to NICU), but concerning secondary outcome parameters: there were significantly more cases with the diagnosis oligohydramnios (9,8 vs...
February 2018: Zeitschrift Für Geburtshilfe und Neonatologie
Wei-Lun Chang, Carit Jacques Andersen, Besa Shatri Berisha, Olena Estrup, Shr-Jie Wang
OBJECTIVE: Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. DESIGN: Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. PATIENTS: Thirty-four torture/war victims with comorbid conditions enrolled in 2012-2013. METHODS: Participants were randomly assigned to an "intervention" and a "waiting-list" group...
February 28, 2018: Journal of Rehabilitation Medicine
Nuala Whelan, Sinéad McGilloway, Mary P Murphy, Colm McGuinness
BACKGROUND: Labour market policy (LMP) and its implementation have undergone rapid change internationally in the last three decades with a continued trend towards active LMP. In Ireland however, this shift has been more recent with ongoing reforms since 2012 and a concomitant move toward active labour market 'work-first' policy design (i.e. whereby unemployed people are compulsorily required to work in return for their social welfare benefits). Labour market policies vary from those that require this compulsory approach to those which enable the unemployed to move towards sustainable quality work in the labour market through upskilling (human capital approach)...
February 26, 2018: Trials
Kassam Mahomed, Kellie Wild, Christopher R Weekes
BACKGROUND: Pre-labour rupture of membranes (PROM) at term is a common event with early induction of labour reducing infectious morbidity without increasing the caesarean rate. Syntocinon is commonly used for induction but prostaglandins are also routinely used. Large studies have shown no difference in the maternal and neonatal outcomes with either method. AIM: To assess the safety and efficacy of vaginal prostaglandin (PG) compared to syntocinon for induction of labour in term-PROM...
February 22, 2018: Australian & New Zealand Journal of Obstetrics & Gynaecology
Haleema Shakur, Danielle Beaumont, Sue Pavord, Angele Gayet-Ageron, Katharine Ker, Hatem A Mousa
BACKGROUND: Postpartum haemorrhage (PPH) - heaving bleeding within the first 24 hours after giving birth - is one of the main causes of death of women after childbirth. Antifibrinolytics, primarily tranexamic acid (TXA), have been shown to reduce bleeding in surgery and safely reduces mortality in trauma patients with bleeding without increasing the risk of adverse events.An earlier Cochrane review on treatments for primary PPH covered all the various available treatments - that review has now been split by types of treatment...
February 20, 2018: Cochrane Database of Systematic Reviews
Adel M Nada, Reham A Mohsen, Yosra M Hassan, Amira Sabry, Noha S Soliman
BACKGROUND: Maternal rectal enemas may reduce neonatal bacterial exposure during labour; this may reduce the risk of neonatal colonization with Clostridium difficile. The aim of this study was to determine the effectiveness of a saline enema during the first stage of labour in reducing neonatal colonization with C. difficile. METHODS: The study was conducted in Cairo University Hospital from January 2016 to July 2016. Asymptomatic mothers with uncomplicated vaginal delivery and their neonates without diarrhea were included...
February 13, 2018: Journal of Hospital Infection
Kenneth Lim, Kimberly Butt, Joan M Crane
OBJECTIVES: To review (1) the use of ultrasonographic-derived cervical length measurement in predicting preterm birth and (2) interventions associated with a short cervical length. OUTCOMES: Reduction in rates of prematurity and/or better identification of those at risk, as well as possible prevention of unnecessary interventions. EVIDENCE: Published literature was retrieved through searches of PubMed and The Cochrane Library up to December 2009, using appropriate controlled vocabulary and key words (preterm labour, ultrasound, cervix, incompetent cervix, transvaginal, transperineal, cervical length, fibronectin)...
February 2018: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
Peter Brocklehurst, David Field, Keith Greene, Edmund Juszczak, Sara Kenyon, Louise Linsell, Chris Mabey, Mary Newburn, Rachel Plachcinski, Maria Quigley, Philip Steer, Liz Schroeder, Oliver Rivero-Arias
BACKGROUND: Continuous electronic fetal monitoring (EFM) in labour is widely used and computerised interpretation has the potential to increase its utility. OBJECTIVES: This trial aimed to find out whether or not the addition of decision support software to assist in the interpretation of the cardiotocograph (CTG) reduced the number of poor neonatal outcomes, and whether or not it was cost-effective. DESIGN: Two-arm individually randomised controlled trial...
February 2018: Health Technology Assessment: HTA
Mahnaz Kalati, Maryam Kashanian, Fereshteh Jahdi, Mohsen Naseri, Hamid Haghani, Narges Sheikhansari
The purpose of the present study was to evaluate the effects of evening primrose oil (EvPO) on the duration of pregnancy and labour. The study was performed as a triple blind placebo controlled randomised clinical trial on nulliparous low-risk women with a certain gestational age of 40 weeks of pregnancy and a Bishop score of less than 4. In the case group (EvPO group), EvPO capsules were administered, 1000 mg, twice daily, for 7 days, and in the control group, placebo was administered similarly. The women of the two groups were followed up to delivery...
February 9, 2018: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
Linda M Biesty, Aoife M Egan, Fidelma Dunne, Valerie Smith, Pauline Meskell, Eugene Dempsey, G Meabh Ni Bhuinneain, Declan Devane
BACKGROUND: Pregnant women with pre-existing diabetes (Type 1 or Type 2) have increased rates of adverse maternal and neonatal outcomes. Current clinical guidelines support elective birth, at or near term, because of increased perinatal mortality during the third trimester of pregnancy.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with pre-existing diabetes (Type 1 or Type 2) and a sister review focuses on women with gestational diabetes...
February 9, 2018: Cochrane Database of Systematic Reviews
Helge Hebestreit, Larry C Lands, Nancy Alarie, Jonathan Schaeff, Chantal Karila, David M Orenstein, Don S Urquhart, Erik H J Hulzebos, Lothar Stein, Christian Schindler, Susi Kriemler, Thomas Radtke
BACKGROUND: Physical activity (PA) and exercise have become an accepted and valued component of cystic fibrosis (CF) care. Regular PA and exercise can positively impact pulmonary function, improve physical fitness, and enhance health-related quality of life (HRQoL). However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labour intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic...
February 8, 2018: BMC Pulmonary Medicine
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