scholarly journals Does progesterone prophylaxis to prevent preterm labour improve outcome? A randomised double-blind placebo-controlled trial (OPPTIMUM)

2018 ◽  
Vol 22 (35) ◽  
pp. 1-304 ◽  
Author(s):  
Jane E Norman ◽  
Neil Marlow ◽  
Claudia-Martina Messow ◽  
Andrew Shennan ◽  
Philip R Bennett ◽  
...  
Keyword(s):  
Placebo Group ◽  
Preterm Birth ◽  
High Risk ◽  
Controlled Trial ◽  
Composite Score ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Individual Patient Level

Background Progesterone prophylaxis is widely used to prevent preterm birth but is not licensed and there is little information on long-term outcome. Objective To determine the effect of progesterone prophylaxis in women at high risk of preterm birth on obstetric, neonatal and childhood outcomes. Design Double-blind, randomised placebo-controlled trial. Setting Obstetric units in the UK and Europe between February 2009 and April 2013. Participants Women with a singleton pregnancy who are at high risk of preterm birth because of either a positive fibronectin test or a negative fibronectin test, and either previous spontaneous birth at ≤ 34 weeks+0 of gestation or a cervical length of ≤ 25 mm. Interventions Fibronectin test at 18+0 to 23+0 weeks of pregnancy to determine risk of preterm birth. Eligible women were allocated (using a web-based randomisation portal) to 200 mg of progesterone or placebo, taken vaginally daily from 22+0 to 24+0 until 34+0 weeks’ gestation. Participants, caregivers and those assessing the outcomes were blinded to group assignment until data collection was complete. Main outcome measures There were three primary outcomes, as follows: (1) obstetric – fetal death or delivery before 34+0 weeks’ gestation; (2) neonatal – a composite of death, brain injury on ultrasound scan (according to specific criteria in the protocol) and bronchopulmonary dysplasia; and (3) childhood – the Bayley-III cognitive composite score at 22–26 months of age. Results In total, 96 out of 600 (16%) women in the progesterone group and 108 out of 597 (18%) women in the placebo group had the primary obstetric outcome [odds ratio (OR) 0.86, 95% confidence interval (CI) 0.61 to 1.22]. Forty-six out of 589 (8%) babies of women in the progesterone group and 62 out of 587 (11%) babies of women in the placebo group experienced the primary neonatal outcome [OR 0.72, 95% CI 0.44 to 1.17]. The mean Bayley-III cognitive composite score of the children at 2 years of age was 97.3 points [standard deviation (SD) 17.9 points; n = 430] in the progesterone group and 97.7 points (SD 17.5 points; n = 439) in the placebo group (difference in means –0.48, 95% CI –2.77 to 1.81). Limitations Overall compliance with the intervention was 69%. Harms There were no major harms, although there was a trend of more deaths from trial entry to 2 years in the progesterone group (20/600) than in the placebo group (16/598) (OR 1.26, 95% CI 0.65 to 2.42). Conclusions In this study, progesterone had no significant beneficial or harmful effects on the primary obstetric, neonatal or childhood outcomes.The OPPTIMUM trial is now complete. We intend to participate in a comprehensive individual patient-level data meta-analysis examining women with a singleton pregnancy with a variety of risk factors for preterm birth. Trial registration Current Controlled Trials ISRCTN14568373. Funding This trial was funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership.

scholarly journals CHInese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy

2015 ◽  
Vol 39 (5-6) ◽  
pp. 309-318 ◽  
Author(s):  
Narayanaswamy Venketasubramanian ◽  
Sherry H. Young ◽  
San San Tay ◽  
Thirugnanam Umapathi ◽  
Annabelle Y. Lao ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Functional Independence ◽  
Stroke Recovery ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Time Points

Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.

Ten-Year Follow-Up of 50 Patients with Bulimia Nervosa

1994 ◽  
Vol 164 (1) ◽  
pp. 80-87 ◽  
Author(s):  
Sunny Collings ◽  
Michael King
Keyword(s):  
Bulimia Nervosa ◽  
Controlled Trial ◽  
Age At Onset ◽  
Eating Attitudes ◽  
Favourable Outcome ◽  
Sufficient Information ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Psychiatric Status

Long-term outcome studies for people suffering from bulimia nervosa are few. Ten years after presentation, we followed up 50 patients (49 women, 1 man) who were originally involved in a double-blind, controlled trial of the antidepressant mianserin. Standardised interviews and questionnaires were used to assess eating attitudes and behaviour, psychiatric status and social functioning. A DSM–III–R diagnosis was given where appropriate. Sufficient information to make a diagnosis was obtained for 44 subjects (88%). Of patients traced, 52% had recovered fully and only 9% continued to suffer the full syndrome; 39% continued to experience some symptoms. Significant predictors of favourable outcome were younger age at onset, higher social class and a family history of alcohol abuse. Outcome for bulimia nervosa continues to improve over ten years with the majority of patients eventually making a full recovery or suffering only moderate abnormalities in eating attitudes. Although predictors of recovery were few, it would appear that intervention has a significant impact on ultimate outcome.

scholarly journals Effect of omega-3 LCPUFA supplementation on maternal fatty acid and oxylipin concentrations during pregnancy

2020 ◽  
Author(s):  
K P Best ◽  
R A Gibson ◽  
L N Yelland ◽  
S Leemaqz ◽  
J Gomersall ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Fatty Acid ◽  
Preterm Birth ◽  
Polyunsaturated Fatty Acids ◽  
Controlled Trial ◽  
Dried Blood Spots ◽  
Omega 3 ◽  
Singleton Pregnancy ◽  
Double Blind ◽  
Total Blood

ABSTRACTIntroductionOmega-3 long chain polyunsaturated fatty acids (LCPUFA) have been associated with a reduction in risk for preterm birth. However, there is limited understanding of how fatty acids and their bioactive derivatives (oxylipins) change over the course of pregnancy. Here we document the changes in concentration of fatty acids and oxylipins during pregnancy and how fatty acid status and oxylipin concentrations are affected by supplementation with omega-3 LCPUFA. We also investigate the degree to which fatty acid and oxylipin changes across pregnancy are influenced by baseline omega-3 status.Materials and MethodsWe profiled the fatty acids in all lipids in dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins in separate dried blood spot samples by LC-MS-MS collected from a random sample of 1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial. ORIP is a double-blind, randomized controlled trial involving 5544 participants and designed to determine the effect of supplementing the diets of pregnant women with omega-3 LCPUFA on the incidence of early preterm birth. Maternal whole blood finger prick samples were collected at baseline (∼14 weeks gestation) and at completion of the study intervention period (34 weeks gestation).ResultsThe concentration of most total and free polyunsaturated fatty acids and their associated oxylipins declined over the course of pregnancy. Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA. The intervention had minimal or no effect on free EPA, LA, AA and their associated oxylipins. Omega-3 LCPUFA supplementation in women with higher omega-3 status at baseline was associated with a significant increase in 7-HDHA and 4-HDHA between the treatment and control whereas there were no differences between groups in 7-HDHA and 4-HDHA in women with intermediate or lower baseline omega-3 status.ConclusionOur data suggest a differential response with or without omega-3 supplementation for DHA and DHA-derived oxylipins, which may have an important role to play in modulating pregnancy duration. Further work is needed to understand their role, which may allow us to better tailor omega-3 supplementation for preterm birth prevention.

Intravenous Immunoglobulin Therapy for Prevention of Infection in High-Risk Premature Infants: Report of a Multicenter, Double-Blind Study

PEDIATRICS ◽  
1991 ◽  
Vol 88 (3) ◽  
pp. 437-443
Author(s):  
Jean-François Magny ◽  
Clothilde Bremard-Oury ◽  
Dominique Brault ◽  
Claudie Menguy ◽  
Marcel Voyer ◽  
...  
Keyword(s):  
Placebo Group ◽  
High Risk ◽  
Deleterious Effect ◽  
Controlled Trial ◽  
Immunoglobulin Therapy ◽  
Double Blind Study ◽  
Double Blind ◽  
Intravenous Immunoglobulin Therapy ◽  
Probable Infection ◽  
And Control

The effectiveness of intravenously administered immunoglobulin (Ig) therapy for prophylaxis of infection was evaluated in high-risk preterm infants. Two hundred thirty-five premature newborns were randomly assigned, in a double-blind controlled trial, to treatment and placebo groups. Thirty-five infants (29%) of the Ig group and 29 (25%) of the placebo group had one or more episodes of certain infection. Thirty infants (25%) of the Ig group and 18 (16%) of the placebo group had one or more episodes of probable infection. No significant differences were observed in the incidence of certain or probable infection in treated and control infants. Nevertheless, among the infants who had one or more certain or probable episodes of infection, more of them belonged to the Ig group than to the placebo group. The possible deleterious effect of the administration of large amounts of polyspecific Ig is discussed.

A double-blind, placebo-controlled trial of triheptanoin in adult polyglucosan body disease and open-label, long-term outcome

2017 ◽  
Vol 41 (5) ◽  
pp. 877-883 ◽  
Author(s):  
Raphael Schiffmann ◽  
Mary E. Wallace ◽  
Daisy Rinaldi ◽  
Isabelle Ledoux ◽  
Marie-Pierre Luton ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Open Label ◽  
Double Blind ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Double Blind Placebo ◽  
Polyglucosan Body ◽  
Adult Polyglucosan Body Disease

scholarly journals Randomized, Double-Blind, Placebo-Controlled Trial of Monthly versus Bimonthly Dihydroartemisinin-Piperaquine Chemoprevention in Adults at High Risk of Malaria

2012 ◽  
Vol 56 (3) ◽  
pp. 1571-1577 ◽  
Author(s):  
Khin Maung Lwin ◽  
Aung Pyae Phyo ◽  
Joel Tarning ◽  
Warunee Hanpithakpong ◽  
Elizabeth A. Ashley ◽  
...  
Keyword(s):  
Placebo Group ◽  
High Risk ◽  
Protective Efficacy ◽  
Day Treatment ◽  
Controlled Trial ◽  
Intermittent Preventive Treatment ◽  
Preventive Treatment ◽  
Adult Males ◽  
Double Blind ◽  
Content Type

ABSTRACTIntermittent preventive treatment (IPT) is increasingly used to reduce malaria morbidity and mortality in children and pregnant women. The efficacy of IPT depends on the pharmacokinetic and pharmacodynamic properties of the antimalarial drugs used. Healthy adult male volunteers whose occupation put them at high risk of malaria on the Northwest border of Thailand were randomized to receive a 3-day-treatment dose of dihydroartemisinin-piperaquine monthly (DPm) or every 2 months (DPalt) or an identical placebo with or without fat (6.4g/dose) over a 9-month period. All volunteers were monitored weekly. One thousand adults were recruited. Dihydroartemisinin-piperaquine was well tolerated. There were 114 episodes of malaria (49Plasmodium falciparum, 63P. vivax, and 2P. ovale). The protective efficacy against all malaria at 36 weeks was 98% (95% confidence interval [CI], 96% to 99%) in the DPm group and 86% (95% CI, 81% to 90%) in the DPalt group (for both,P< 0.0001 compared to the placebo group). As a result, the placebo group also had lower hematocrits during the study (P< 0.0001). Trough plasma piperaquine concentrations were the main determinant of efficacy; no malaria occurred in participants with a trough concentration above 31 ng/ml. Neither plasma piperaquine concentration nor efficacy was influenced by the coadministration of fat. DPm is safe to use and is effective in the prevention of malaria in adult males living in an area whereP. vivaxand multidrug-resistantP. falciparummalaria are endemic.

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