Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE)

<p>Abstract</p> <p>Background</p> <p>Maternal smoking is the most significant cause of preventable complications during pregnancy, with smoking cessation during pregnancy shown to increase birth weight and reduce preterm birth among pregnant women who quit smoking. Taking into account the fact that the number of women who smoke in Greece has increased steadily throughout the previous decade and that the prevalence of smoking among Greek females is one of the highest in the world, smoking cessation should be a top priority among Greek health care professionals.</p> <p>Methods/Design</p> <p>The Maternal Smoking Cessation during Pregnancy Study (M-SCOPE), is a Randomized Control Trial (RCT) that aims to test whether offering Greek pregnant smokers a high intensity intervention increases smoking cessation during the third trimester of pregnancy, when compared to a low intensity intervention. Prospective participants will be pregnant smokers of more than 5 cigarettes per week, recruited up to the second trimester of pregnancy. Urine samples for biomarker analysis of cotinine will be collected at three time points: at baseline, at around the 32^ndweek of gestation and at six months post partum. The control group/low intensity intervention will include: brief advice for 5 minutes and a short leaflet, while the experimental group/intensive intervention will include: 30 minutes of individualized cognitive-behavioural intervention provided by a trained health professional and a self-help manual especially tailored for smoking cessation during pregnancy, while counselling will be based on the ''5 As.'' After childbirth, the infants' birth weight, gestational age and any other health related complications during pregnancy will be recorded. A six months post-partum a follow up will be performed in order to re-assess the quitters smoking status.</p> <p>Discussion</p> <p>If offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation in comparison to a usual care low intensity intervention in Greek pregnant smokers, such a scheme if beneficial could be implemented successfully within clinical practice in Greece.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov Identifier <a href="http://www.clinicaltrials.gov/ct2/show/NCT01210118">NCT01210118</a></p

Predictive value of fetal scalp pH and base excess for fetal acidosis and poor neonatal outcome

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Relationship between maternal bone biomarkers and fetal adiposity through normal pregnancy

Purpose To examine the association of maternal bone markers (sclerostin, sRANKL, osteocalcin, 25OHD3) with fetal intra-abdominal and subcutaneous adipose tissue deposition and birthweight during normal pregnancy. Methods One hundred pregnant women (aged 30.4±5.6 years, mean±SD) with pre-pregnancy BMI=24.1±4.6 kg/m² were seen prospectively during each trimester. At each visit they were submitted to anthropometric measurements, a fasting blood sampling, a 75gr oral glucose tolerance test (OGTT) and a fetal ultrasonogram. At birth, neonates had birth weight measurement. Results In the 2 nd trimester maternal sclerostin concentrations correlated positively with fetal abdominal circumference and birth weight; maternal sRANKL concentrations correlated positively with fetal abdominal subcutaneous fat thickness, sagittal abdominal diameter and abdominal circumference. Fetuses born to mothers with greater (>254 ng/mL) compared to fetuses born to mothers with lower (≤254 ng/mL) sRANKL concentrations had greater abdominal circumference, sagittal diameter and abdominal subcutaneous fat thickness. Maternal serum sclerostin concentrations were the best positive predictors of birth weight. In the 3 rd trimester maternal sclerostin concentrations correlated positively with fetal sagittal abdominal diameter; maternal sRANKL concentrations positively correlated with fetal abdominal circumference and fetal abdominal sagittal diameter. Conclusions Maternal bone markers sclerostin and sRANKL may relate with fetal intra-abdominal adipose tissue deposition through direct or indirect unknown as yet mechanisms contributing thus, to birthweight

Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial.

INTRODUCTION: Smoking cessation during pregnancy is beneficial to both the mother and child. Our objective was to assess if an intensive smoking cessation intervention for pregnant women increases: a) rates of smoking cessation, and b) reduces exposure to tobacco-specific carcinogens during pregnancy. METHODS: A two-group single-blinded parallel randomized controlled trial (RCT) was conducted involving 84 pregnant smokers in either a high intensity (n=42) or minimal contact control group (n=42). Women assigned to the high intensity smoking cessation intervention group received a single 30-minute behavioural counselling session and a tailored self-help booklet. The primary outcome measures were: 7-day point prevalence abstinence measured by selfreport and urine cotinine levels, and maternal tobacco specific carcinogens nitrosamine (NNAL) urine concentrations assessed at 32 weeks of gestation. RESULTS: A significantly greater percentage of pregnant smokers quit smoking in the high intensity group compared to the low intensity control group (45.2% vs 21.4%; p=0.001). A significant decrease in urine cotinine concentrations was documented in the experimental group (-140.74 ± 361.70 ng/mL; p=0.004), with no significant decrease documented in the control group. A significant decrease in NNAL levels was also documented in the experimental group (158.17 ± 145.03 pg/mL before, 86.43 ± 112.54 pg/mL after; p=0.032) with no significant changes in the control group. CONCLUSIONS: The high intensity intervention tested resulted in significantly greater cessation rates. Intensive smoking cessation interventions can be effective in reducing fetal exposure to NNAL. This is the first trial to report on NNAL tobacco-specific carcinogen concentrations before and after an intervention for smoking cessation during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01210118. ABBREVIATIONS: 5Αs: ask, advise, asses, assist, arrange; GHQ: general health questionnaire; ANOVA: analysis of variance; RCT: randomized control trials; NNAL: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol

Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial

Introduction Smoking cessation during pregnancy is beneficial to both the mother and child. Our objective was to assess if an intensive smoking cessation intervention for pregnant women increases: a) rates of smoking cessation, and b) reduces exposure to tobacco-specific carcinogens during pregnancy. Methods A two-group single-blinded parallel randomized controlled trial (RCT) was conducted involving 84 pregnant smokers in either a high intensity (n=42) or minimal contact control group (n=42). Women assigned to the high intensity smoking cessation intervention group received a single 30-minute behavioural counselling session and a tailored self-help booklet. The primary outcome measures were: 7-day point prevalence abstinence measured by selfreport and urine cotinine levels, and maternal tobacco specific carcinogens nitrosamine (NNAL) urine concentrations assessed at 32 weeks of gestation. Results A significantly greater percentage of pregnant smokers quit smoking in the high intensity group compared to the low intensity control group (45.2% vs 21.4%; p=0.001). A significant decrease in urine cotinine concentrations was documented in the experimental group (-140.74 ± 361.70 ng/mL; p=0.004), with no significant decrease documented in the control group. A significant decrease in NNAL levels was also documented in the experimental group (158.17 ± 145.03 pg/mL before, 86.43 ± 112.54 pg/mL after; p=0.032) with no significant changes in the control group. Conclusions The high intensity intervention tested resulted in significantly greater cessation rates. Intensive smoking cessation interventions can be effective in reducing fetal exposure to NNAL. This is the first trial to report on NNAL tobacco-specific carcinogen concentrations before and after an intervention for smoking cessation during pregnancy