Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?

AbstractObjectivesIncreased placental stiffness is associated with various pathological conditions. Our objective was to evaluate the relation between the second-trimester placental elasticity value in low-risk pregnant women and poor obstetric outcomes.MethodsA total of 143 pregnant women were enrolled. Placental elasticity values were measured using the transabdominal point shear wave elastography method. 10 random measurements were obtained from different areas of the placenta. The mean was accepted as the mean placental elasticity value. Logistic regression analyses were performed to identify independent variables associated with obstetric outcomes.ResultsSecond-trimester placental elasticity value was significantly and positively associated with the poor obstetric outcomes (p=0.038). We could predict a poor outcome with 69.2% sensitivity and 60.7% specificity if we defined the placental elasticity cut-off as 3.19 kPa. Furthermore, in the multiple regression model, the placental elasticity value added significantly to the prediction of birth weight (p=0.043).ConclusionsOur results showed that the pregnancies with a stiffer placenta in the second trimester were associated with an increased likelihood of exhibiting poor obstetric outcomes. Also, placental elasticity was independently associated with birth weight.

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Third trimester ultrasound estimated fetal weight for increasing prenatal prediction of small-for-gestational age newborns in low-risk pregnant women

The Journal of Maternal-Fetal & Neonatal Medicine ◽

10.1080/14767058.2021.1920915 ◽

2021 ◽

pp. 1-6

Author(s):

Giovanna Martín-Palumbo ◽

Vangeliya Blagoeva Atanasova ◽

María Teresa Rego Tejeda ◽

Eugenia Antolín Alvarado ◽

José Luis Bartha

Keyword(s):

Pregnant Women ◽

Gestational Age ◽

Small For Gestational Age ◽

Low Risk ◽

Fetal Weight ◽

Third Trimester ◽

Estimated Fetal Weight

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The impact of minimally invasive restorative techniques on perception of dental pain among pregnant women: a randomized controlled clinical trial

BMC Oral Health ◽

10.1186/s12903-021-01432-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

May M. Adham ◽

Mona K. El Kashlan ◽

Wafaa E. Abdelaziz ◽

Ahmed S. Rashad

Keyword(s):

Clinical Trial ◽

Dental Caries ◽

Pregnant Women ◽

Dental Pain ◽

Controlled Clinical Trial ◽

Atraumatic Restorative Treatment ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Caries Removal ◽

The Impact

Abstract Background The public dental care sector is striving to fulfill the preventive and restorative needs of Egyptians, including pregnant women, who may not receive timely care due to misconceptions about dental treatment during pregnancy. Because of this, they are likely to suffer dental pain, with higher risk of infection affecting their offsprings. Aim of the study To compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain among pregnant women. Materials and methods A randomized controlled clinical trial was conducted, in 2019, and included 162 pregnant women visiting family health centers in Alexandria, Egypt, with dental pain due to dental caries not extending to pulp. Patients were randomly assigned to Papacarie-Duo group (n = 82) and ART group (n = 80) after stratification by number of treated surfaces. The outcome variables were reduction in pain assessed using Visual Analogue Scale (VAS), satisfaction with treatment, and time taken for dental caries removal. T test/ Mann Whitney U test were used to compare groups and Freidman test was used to compare change across time. Results Pain reduction was significantly greater in the Papacarie-Duo than the ART group (81.55% and 69.43%, P = 0.001). Patients in the Papacarie-Duo group were significantly more satisfied with treatment than those in the ART, immediately after treatment (mean = 9.60 and 8.00, P = < 0.01) and after 6 months (mean = 9.63 and 8.16, P = < 0.01). Significantly less excavation time was recorded in the Papacarie-Duo group than in the ART group (mean = 10.38 and 11.56 min, P = < 0.01). Conclusion Chemo-mechanical caries removal using Papacarie-Duo is more effective in reducing dental pain, in pregnant women, and is associated with more satisfaction and less excavation time than ART. Trial registration: ID NCT04573608 (https://clinicaltrials.gov/); 5/10/2020, retrospective registration.

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Papillomaviral infection and cervical diseases in pregnant women. Risk factors of social status, reproductive and contraceptive behavior

GYNECOLOGY ◽

10.26442/20795696.2020.6.200460 ◽

2020 ◽

Vol 22 (6) ◽

pp. 74-79

Author(s):

Tamara N. Bebneva ◽

Galina B. Dikke

Keyword(s):

Risk Factors ◽

Pregnant Women ◽

Social Status ◽

Significant Risk ◽

Hpv Infection ◽

Low Risk ◽

Contraceptive Behavior ◽

Regular Screening ◽

History Of ◽

Cervical Diseases

Aim. To determine the risk factors for human papillomavirus of high carcinogenic risk (HPV HCR) and cervical diseases (CD) in pregnant women associated with the social status, reproductive and contraceptive behavior. Materials and methods. Design: open-label comparative non-interventional cohort study in parallel groups. The total number of patients 330 people, of whom 148 women were negative for HPV and 182 women were positive. They were divided into 4 groups depending on the presence or absence of CD. Methods: analysis of anamnesis data, general clinical, test Kvant-21 to determine HPV, cytological examination, extended colposcopy. Results. The most significant risk factors for HPV HRS infection were identified: history of mycoplasma infection (OR 5.9) and BV (OR 5.3), alcohol consumption (OR 4.0). A history of STIs (trichomoniasis and chlamydial infection), as well as more than 3 sexual partners (OR 2.7) were also significant. The most significant risk factors for CD in HPV-infected women were: age over 35 years (OR 3.8), a history of bacterial vaginosis (OR 3.0), and lack of regular screening (OR 2.4). The coitarche earlier than 16 years old (OR 2.2) also mattered. There were also found factors indicating a low risk of HPV infection the use of condoms (OR 0.3), and a low risk of CD was indicated by age under 25 years (OR 0.2) and regular screening (OR 0.3). Conclusion. HPV infection with HRS and the prevalence of CMC in pregnant women against the background of HPV infection is associated mainly with social risk factors, to a lesser extent with factors of reproductive and contraceptive behavior.

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