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Trial obstetrics

S J Lain, C L Roberts, D M Bond, J Smith, J M Morris
OBJECTIVE: This study is an economic evaluation of immediate birth compared with expectant management in women with preterm prelabour rupture of the membranes near term (PPROMT). DESIGN: A cost-effectiveness analysis alongside the PPROMT randomised controlled trial. SETTING: Obstetric departments in 65 hospitals across 11 countries. POPULATION: Women with a singleton pregnancy with ruptured membranes between 34(+0) and 36(+6) weeks gestation...
October 21, 2016: BJOG: An International Journal of Obstetrics and Gynaecology
Mieke L G Ten Eikelder, Kelly Mast, Annemarie van der Velden, Kitty W M Bloemenkamp, Ben W Mol
Importance: Induction of labor is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, still many different induction methods are used. Objective: We compared Foley catheter alone to different misoprostol dosages and administration routes, and the combination of Foley catheter with misoprostol. Evidence acquisition: We reviewed the literature on the best induction method regarding their safety and effectiveness, using the outcome measures hyperstimulation, fetal distress, neonatal morbidity and mortality as well as cesarean delivery, vaginal instrumental delivery, and maternal morbidity...
October 2016: Obstetrical & Gynecological Survey
C Baeza, N Mottet, C Coppola, M Desmarets, R Ramanah, D Riethmuller
OBJECTIVE: To assess delivery mode, maternal morbidity including uterine rupture and scar dehiscence and neonatal outcome, during a pregnancy after a previous caesarean delivery before 32 weeks of amenorrhea. METHODS: A retrospective descriptive study was carried out at the Besançon University Hospital during an 8-year period. We identified 292 consecutive patients presenting a singleton pregnancy delivery before 32 weeks of amenorrhea. We analysed the next pregnancy...
October 17, 2016: Gynécologie, Obstétrique & Fertilité
Jan Bonhoeffer, Sonali Kochhar, Steven Hirschfeld, Paul T Heath, Christine E Jones, Jorgen Bauwens, Ángel Honrado, Ulrich Heininger, Flor M Muñoz, Linda Eckert, Mark Steinhoff, Steven Black, Michael Padula, Miriam Sturkenboom, Jim Buttery, Robert Pless, Patrick Zuber
Immunization in pregnancy provides a promising contribution to globally reducing neonatal and under-five childhood mortality and morbidity. Thorough assessment of benefits and risks for the primarily healthy pregnant women and their unborn babies is required. The GAIA project was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC...
October 14, 2016: Vaccine
Xiang Kong, Yan Kong, Fangyuan Zhang, Tingting Wang, Jin Yan
BACKGROUND: Intrahepatic cholestasis of pregnancy (ICP) is a specific pregnancy-related disorder without standard medical therapies. Ursodeoxycholic acid (UDCA) is the most used medicine, but the efficacy and safety of UDCA remain uncertain. Several meta-analyses had been made to assess the effects of UDCA in ICP. However, the samples were not large enough to convince obstetricians to use UDCA. We conducted a meta-analysis to evaluate the effects and safety of UDCA in patients with ICP, which included only randomized controlled trials (RCTs)...
October 2016: Medicine (Baltimore)
Amit M Oza, Frédéric Selle, Irina Davidenko, Jacob Korach, Cesar Mendiola, Patricia Pautier, Ewa Chmielowska, Aristotelis Bamias, Andrea DeCensi, Zanete Zvirbule, Antonio González-Martín, Roberto Hegg, Florence Joly, Claudio Zamagni, Angiolo Gadducci, Nicolas Martin, Stephen Robb, Nicoletta Colombo
OBJECTIVE: The aim of this study was to assess the safety and efficacy of extending bevacizumab therapy beyond 15 months in nonprogressive ovarian cancer. PATIENTS AND METHODS: In this multinational prospective single-arm study ( NCT01239732), eligible patients had International Federation of Gynecology and Obstetrics stage IIB to IV or grade 3 stage I to IIA ovarian cancer without clinical signs or symptoms of gastrointestinal obstruction or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the preceding 6 months...
October 4, 2016: International Journal of Gynecological Cancer
Ali M Mokhtar, Ahmed I Elsakka, Hassan M Ali
BACKGROUND: Anxiety is a concern in obstetrics, especially in preeclamptic mothers. Sedation is not commonly used in parturients for fear of adverse neonatal effect. We investigated maternal and neonatal outcome of midazolam as an adjuvant to spinal anesthesia for elective cesarean delivery. METHODS: A prospective randomized controlled trial, in which eighty preeclamptic parturients received either an intravenous dose of 0.035 mg/kg of midazolam or an equal volume of normal saline, 30 min before spinal anesthesia...
September 2016: Anesthesia, Essays and Researches
Lianne M Tomfohr-Madsen, Tavis S Campbell, Gerald F Giesbrecht, Nicole L Letourneau, Linda E Carlson, Joshua W Madsen, Sona Dimidjian
BACKGROUND: Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy...
October 13, 2016: Trials
Frederico S Falcetta, Theresa A Lawrie, Lídia Rf Medeiros, Maria Ines da Rosa, Maria I Edelweiss, Airton T Stein, Alice Zelmanowicz, Anaelena B Moraes, Roselaine R Zanini, Daniela D Rosa
BACKGROUND: This is an updated version of the original review that was first published in the Cochrane Database of Systematic Reviews 2008, Issue 4. Laparoscopy has become an increasingly common approach to surgical staging of apparent early-stage ovarian tumours. This review was undertaken to assess the available evidence on the benefits and risks of laparoscopy compared with laparotomy for the management of International Federation of Gynaecology and Obstetrics (FIGO) stage I ovarian cancer...
October 13, 2016: Cochrane Database of Systematic Reviews
D Jurkovic, M Memtsa, E Sawyer, Ana Donaldson, A Jamil, K Schramm, Y Sana, M Otify, L Farahani, N Nunes, G Ambler, J A Ross
OBJECTIVE: Methotrexate is routinely used worldwide for medical treatment of clinically stable women with tubal ectopic pregnancies. This is despite the lack of robust evidence to show its superior effectiveness over expectant management. The aim of our multicentre randomised trial study was to compare the success rates of methotrexate with placebo for the conservative treatment of tubal ectopic pregnancies. METHODS: The study was multicentre; it took place in three UK early pregnancy units between January 2006 and June 2014...
October 12, 2016: Ultrasound in Obstetrics & Gynecology
Amy O'Donnell, Catherine McParlin, Stephen C Robson, Fiona Beyer, Eoin Moloney, Andrew Bryant, Jennifer Bradley, Colin Muirhead, Catherine Nelson-Piercy, Dorothy Newbury-Birch, Justine Norman, Emma Simpson, Brian Swallow, Laura Yates, Luke Vale
BACKGROUND: Nausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP - hyperemesis gravidarum (HG) - affects 0.3-1.0% of pregnant women. There is no widely accepted point at which NVP becomes HG. OBJECTIVES: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of treatments for NVP and HG...
October 2016: Health Technology Assessment: HTA
Pedro Hidalgo-Lopezosa, María Hidalgo-Maestre
OBJECTIVE: To assess the risk of uterine rupture (UR) in attempted vaginal birth after cesarean and to identify risk factors. METHODS: Systematic review by consulting the following databases: PubMed (MEDLINE), Cochrane Library Plus, Embase, Nursing@Ovid, Cuidatge and Dialnet. The search was conducted between January and March 2015. MeSH descriptors used were: vaginal birth after cesarean; uterine rupture; labor induced and labor obstetric or trial of labor. There were no restrictions on date or language...
October 7, 2016: Enfermería Clínica
A F Fransen, J van de Ven, E Schuit, Aac van Tetering, B W Mol, S G Oei
OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of gestation. METHODS: Random allocation of obstetric units to a 1-day, multi-professional, simulation-based team training focusing on crew resource management (CRM) in a simulation centre or to no such team training...
October 10, 2016: BJOG: An International Journal of Obstetrics and Gynaecology
S Portz, M Schmidt, M Weitz
Objectives: In many countries pregnant women in term singleton pregnancies are advised by obstetricians and midwives to lie down immediately after rupture of membranes until engagement of the foetal head is confirmed. The horizontal positioning aims to prevent the prolapse of the umbilical cord. The objective of this systematic review is to assess the effects of the maternal lying down measure in term singleton pregnancies. Search methods: We searched the databases of MEDLINE/PubMed, EMBASE/Ovid and CENTRAL (Issue 10, 2015) from their inception until September 30(th), 2015...
October 10, 2016: Zeitschrift Für Geburtshilfe und Neonatologie
Sophie Palmer, Jessica Pudwell, Graeme N Smith, Robert L Reid
OBJECTIVE: To obtain information on women's attitudes and opinions about participation in vaccine and medication trials during pregnancy. METHODS: A quantitative, cross-sectional survey was administered to 110 consenting women over a four-week period in the waiting room of an ambulatory obstetrics and gynaecology clinic in Ontario. RESULTS: The final response rate was 74.8%, with the majority of participants agreeing with statements about the importance of obtaining safety data about products in pregnancy and the importance of a woman having the ability to choose whether to participate in such research...
October 2016: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
David O Akeju, Marianne Vidler, J O Sotunsa, M O Osiberu, E O Orenuga, Olufemi T Oladapo, A A Adepoju, Rahat Qureshi, Diane Sawchuck, Olalekan O Adetoro, Peter von Dadelszen, Olukayode A Dada
BACKGROUND: The dearth of health personnel in low income countries has attracted global attention. Ways as to how health care services can be delivered in a more efficient and effective way using available health personnel are being explored. Task-sharing expands the responsibilities of low-cadre health workers and allows them to share these responsibilities with highly qualified health care providers in an effort to best utilize available human resources. This is appropriate in a country like Nigeria where there is a shortage of qualified health professionals and a huge burden of maternal mortality resulting from obstetric complications like pre-eclampsia...
September 30, 2016: Reproductive Health
Sharmila Shrestha, Kumiko Adachi, Marcia A Petrini, Sarita Shrestha, Bina Rana Khagi
BACKGROUND: the health and survival of newborns depend on high levels of attention and care from caregivers. The growth and development of some infants are unhealthy because of their mother's or caregiver's lack of knowledge or the use of inappropriate or traditional child-rearing practices that may be harmful. OBJECTIVE: to develop a newborn care educational programme and evaluate its impact on infant and maternal health in Nepal. DESIGN: a randomised controlled trial...
September 15, 2016: Midwifery
Jesús Zacarías Villarreal Pérez, José Manuel Ramírez Aranda, Manuel de la O Cavazos, Michelle de J Zamudio Osuna, José Perales Dávila, María Romelia Ballesteros Elizondo, Marco Vinicio Gómez Meza, Francisco Javier García Elizondo, Azucena M Rodríguez González
Immunization with the tetanus, diphtheria, and pertussis (Tdap) vaccine raises controversies on immunogenicity and possible antibody interference. We performed an experimental, double-blind, parallel group controlled clinical trial to evaluate the safety and immunogenicity of the Tdap vaccine in 204 pregnant women and their children and to determine its interference in antibody production. Pregnant women 18 to 38 years of age with 12 to 24 weeks gestation, a low obstetric risk, and without serious disease were randomly selected...
September 29, 2016: Human Vaccines & Immunotherapeutics
Virginia A Aparicio, Olga Ocón, Carmen Padilla-Vinuesa, Alberto Soriano-Maldonado, Lidia Romero-Gallardo, Milkana Borges-Cósic, Irene Coll-Risco, Pilar Ruiz-Cabello, Pedro Acosta-Manzano, Fernando Estévez-López, Inmaculada C Álvarez-Gallardo, Manuel Delgado-Fernández, Jonatan R Ruiz, Mireille N Van Poppel, Julio J Ochoa-Herrera
BACKGROUND: During pregnancy, a sedentary lifestyle may have negative consequences on maternal and foetal health status. The main objective of this project is to assess the effects of an exercise intervention in overweight and grade I obese pregnant on maternal and foetal health markers. METHODS/DESIGN: The present study aims to recruit 60 overweight and grade I obese women interested in participating in an exercise intervention program from the 17th gestational week until delivery...
September 29, 2016: BMC Pregnancy and Childbirth
Abha Maheshwari, Edwin Amalraj Raja, Siladitya Bhattacharya
OBJECTIVE: To explore obstetric and perinatal outcomes in singleton pregnancies occurring as a result of fresh and thawed frozen embryo transfer using anonymized Human Fertilisation and Embryology Authority data. DESIGN: Retrospective cohort study. SETTING: Not applicable. PATIENT(S): Singleton births after IVF/intracytoplasmic sperm injection cycles in the United Kingdom (1991-2011). INTERVENTION(S): A total of 112,432 cycles (95,911 fresh and 16,521 frozen) were analyzed using multivariate logistic regression to explore associations between type of embryo transferred (frozen vs...
September 24, 2016: Fertility and Sterility
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