A Randomized Controlled Trial of the Correlation between Iodine Supplementation in Pregnancy and Maternal Urine Iodine and Neonatal Thyroid Stimulating Hormone Levels

Objective: To establish the correlation of maternal urine iodine and neonatal thyroid stimulating hormone (TSH) in iodine supplemented and non-iodine supplemented pregnant women. Methods: The study was a prospective, randomized, controlled trial, which was conducted at the antenatal care unit, labor ward, and neonatal unit of Siriraj Hospital, Mahidol University, Bangkok, Thailand. In all, 224 pregnant women were recruited during 1 October 2015 and 31 July 2017. They were randomized into 2 groups: an iodine and a non-iodine supplemented group. One woman in the control group left the study as she had delivery at another hospital. Results: There were no statistically significant differences in the demographic data, original area of domicile, and adverse neonatal outcomes (including preterm labor and low birth weight) of the patients in the two groups. The maternal urinary iodine levels were 84.14 ± 61.85 and 58.41 ± 41.36 microgram/L, and the median values of the neonatal TSH levels were 3.7 ± 1.87 and 4.4 ± 1.99 mIU/ml, in the iodine and non-iodine supplemented groups, respectively. The differences in both values were statistically significant (p-value < 0.05). Conclusion: This study determined that there were statistically significant differences in the maternal urinary iodine levels and the median values of the neonatal TSH levels of the iodine and non-iodine replacement groups of pregnant women. Even though there were no clinically significant differences and none of the newborns was diagnosed with hypothyroidism, iodine supplementation in all pregnant women should be considered. A larger prospective, RCT trial would confirm the benefits of a strategy of routinely administering iodine to pregnant women at Siriraj Hospital

A Randomized Controlled Trial of the Correlation between Iodine Supplementation in Pregnancy and Maternal Urine Iodine and Neonatal Thyroid Stimulating Hormone Levels

Objective: To establish the correlation of maternal urine iodine and neonatal thyroid stimulating hormone (TSH) in iodine supplemented and non-iodine supplemented pregnant women. Materials and Methods: The study was a prospective, randomized, controlled trial, which was conducted at the antenatal care unit, labor ward, and neonatal unit of Siriraj Hospital, Mahidol University, Bangkok, Thailand. In all, 224 pregnant women were recruited during 1 October 2015 and 31 July 2017. They were randomized into 2 groups: an iodine and a non-iodine supplemented group. One woman in the control group left the study as she had delivery at another hospital. Results: There were no statistically significant differences in the demographic data, original area of domicile, and adverse neonatal outcomes (including preterm labor and low birth weight) of the patients in the two groups. The maternal urinary iodine levels were 84.14 + 61.85 and 58.41 + 41.36 microgram/L, and the median values of the neonatal TSH levels were 3.7 + 1.87 and 4.4 + 1.99 mIU/ml, in the iodine and non-iodine supplemented groups, respectively. The differences in both values were statistically significant (p-value < 0.05). Conclusion: This study determined that there were statistically significant differences in the maternal urinary iodine levels and the median values of the neonatal TSH levels of the iodine and non-iodine replacement groups of pregnant women. Even though there were no clinically significant differences and none of the newborns was diagnosed with hypothyroidism, iodine supplementation in all pregnant women should be considered. A larger prospective, RCT trial would confirm the benefits of a strategy of routinely administering iodine to pregnant women at Siriraj Hospital

Normative Values of Second-Trimester Maternal Serum Markers Using an Automated Assay Platform for Down Syndrome Screening

Objective: Automated chemiluminescent immunoassay has several advantages over manual ELISA with comparable test performance. Few studies have reported the reference values of the second-trimester serum markers maternal serum alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), unconjugated estriol (uE3), and inhibin A (Inh A) by automated immunoassay in Asian population. Accordingly, this study aimed to determine the median values of second trimester serum markers as a function of gestational age (GA) in Thai population using an automated immunoassay. Methods: This prospective cross-sectional study of serum markers in healthy singleton second trimester (14-22 weeks) pregnant women was conducted at Siriraj Hospital from September 2012 to April 2015. Maternal serum AFP, hCG, uE3, and Inh A were analyzed by automated immunoassay. Predicted median values as a function of GA were calculated from best-fit regression equations. Results: A total of 1,526 women were included. Median values serum markers were constructed from the following optimal models: AFP (ng/mL) = 99.082 - 14.195 GA + 0.662 GA2, r2=0.995; hCG (mIU/mL) = 390168.106 - 35 968.397GA + 876.708GA2, r2=0.972; uE3 (ng/mL) = -3.388 + 0.274 GA, r2=0.997; and, Inh-A (pg/mL) = 1206.875 - 114.171 GA + 3.174 GA2, r2=0.882. Using the same platform analysis and maternal weight adjustment, the reference values in Thai population were shown to be different from those of other ethnicities. Conclusion: Median values of second-trimester serum markers for Thai population were determined. Maternal weight and the use of population-specific normal values have to be taken into account for Down syndrome screening in the second trimester

Alternative Magnesium Sulfate Dosing Regimens for Women With Preeclampsia: A Population Pharmacokinetic Exposure-Response Modeling and Simulation Study

Magnesium sulfate is the anticonvulsant of choice for eclampsia prophylaxis and treatment; however, the recommended dosing regimens are costly and cumbersome and can be administered only by skilled health professionals. The objectives of this study were to develop a robust exposure-response model for the relationship between serum magnesium exposure and eclampsia using data from large studies of women with preeclampsia who received magnesium sulfate, and to predict eclampsia probabilities for standard and alternative (shorter treatment duration and/or fewer intramuscular injections) regimens. Exposure-response modeling and simulation were applied to existing data. A total of 10 280 women with preeclampsia who received magnesium sulfate or placebo were evaluated. An existing population pharmacokinetic model was used to estimate individual serum magnesium exposure. Logistic regression was applied to quantify the serum magnesium area under the curve-eclampsia rate relationship. Our exposure-response model-estimated eclampsia rates were comparable to observed rates. Several alternative regimens predicted magnesium peak concentration < 3.5 mmol/L (empiric safety threshold) and eclampsia rate ≤ 0.7% (observed response threshold), including 4 g intravenously plus 10 g intramuscularly followed by either 8 g intramuscularly every 6 hours × 3 doses or 10 g intramuscularly every 8 hours × 2 doses and 10 g intramuscularly every 8 hours × 3 doses. Several alternative magnesium sulfate regimens with comparable model-predicted efficacy and safety were identified that merit evaluation in confirmatory clinical trials

Normative Values of Second-Trimester Maternal Serum Markers Using an Automated Assay Platform for Down Syndrome Screening

Objective: Automated chemiluminescent immunoassay has several advantages over manual ELISA with comparable test performance. Few studies have reported the reference values of the second-trimester serum markers maternal serum alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), unconjugated estriol (uE3), and inhibin A (Inh A) by automated immunoassay in Asian population. Accordingly, this study aimed to determine the median values of second trimester serum markers as a function of gestational age (GA) in Thai population using an automated immunoassay. Methods: This prospective cross-sectional study of serum markers in healthy singleton second trimester (14-22 weeks) pregnant women was conducted at Siriraj Hospital from September 2012 to April 2015. Maternal serum AFP, hCG, uE3, and Inh A were analyzed by automated immunoassay. Predicted median values as a function of GA were calculated from best-fit regression equations. Results: A total of 1,526 women were included. Median values serum markers were constructed from the following optimal models: AFP (ng/mL) = 99.082 - 14.195 GA + 0.662 GA2, r2=0.995; hCG (mIU/mL) = 39, 0168.106 - 35 968.397GA + 876.708GA2, r2=0.972; uE3 (ng/mL) = -3.388 + 0.274 GA, r2=0.997; and, Inh-A (pg/mL) = 1,206.875 - 114.171 GA + 3.174 GA2, r2=0.882. Using the same platform analysis and maternal weight adjustment, the reference values in Thai population were shown to be different from those of other ethnicities. Conclusion: Median values of second-trimester serum markers for Thai population were determined. Maternal weight and the use of population-specific normal values have to be taken into account for Down syndrome screening in the second trimester

A novel method to derive amniotic fluid stem cells for therapeutic purposes

<p>Abstract</p> <p>Background</p> <p>Human amniotic fluid stem (hAFS) cells have become an attractive stem cell source for medical therapy due to both their ability to propagate as stem cells and the lack of ethical debate that comes with the use of embryonic stem cells. Although techniques to derive stem cells from amniotic fluid are available, the techniques have limitations for clinical uses, including a requirement of long periods of time for stem cell production, population heterogeneity and xeno-contamination from using animal antibody-coated magnetic beads. Herein we describe a novel isolation method that fits for hAFS derivation for cell-based therapy.</p> <p>Methods and Results</p> <p>With our method, single hAFS cells generate colonies in a primary culture of amniotic fluid cells. Individual hAFS colonies are then expanded by subculturing in order to make a clonal hAFS cell line. This method allows derivation of a substantial amount of a pure stem cell population within a short period of time. Indeed, 10⁸cells from a clonal hAFS line can be derived in two weeks using our method, while previous techniques require two months. The resultant hAFS cells show a 2-5 times greater proliferative ability than with previous techniques and a population doubling time of 0.8 days. The hAFS cells exhibit typical hAFS cell characteristics including the ability to differentiate into adipogenic-, osteogenic- and neurogenic lineages, expression of specific stem cell markers including Oct4, SSEA4, CD29, CD44, CD73, CD90, CD105 and CD133, and maintenance of a normal karyotype over long culture periods.</p> <p>Conclusions</p> <p>We have created a novel hAFS cell derivation method that can produce a vast amount of high quality stem cells within a short period of time. Our technique makes possibility for providing autogenic fetal stem cells and allogeneic cells for future cell-based therapy.</p

A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.

BACKGROUND: Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries. METHODS: We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics. RESULTS: We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events. CONCLUSIONS: Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.)

Maternal complications and risk factors associated with assisted vaginal delivery

Abstract Objective This study aimed to elucidate the maternal complications and risk factors linked with assisted vaginal delivery. Methods We conducted a retrospective, descriptive analysis of hospital records, identifying 3500 cases of vaginal delivery between 2020 and 2022. Data encompassing demographics, complications from the vaginal delivery including post-partum haemorrhage, birth passage injuries, puerperal infection and other pertinent details were documented. Various critical factors, including the duration of the second stage of labor, maternal anemia, underlying maternal health conditions such as diabetes mellitus and hypertension, neonatal birth weight, maternal weight, the expertise of the attending surgeon, and the timing of deliveries were considered. Results The rates for assisted vacuum and forceps delivery were 6.0% (211/3500 cases) and 0.3% (12/3500), respectively. Postpartum haemorrhage emerged as the predominant complication in vaginal deliveries, with a rate of 7.3% (256/3500; P < 0.001). Notably, postpartum haemorrhage had significant associations with gestational diabetes mellitus class A1 (adjusted odds ratio [AOR] 1.46; 95% confidence interval [CI] 1.01–2.11; P = 0.045), assisted vaginal delivery (AOR 5.11; 95% CI 1.30–20.1; P = 0.020), prolonged second stage of labour (AOR 2.68; 95% CI 1.09–6.58; P = 0.032), elevated maternal weight (71.4 ± 12.2 kg; AOR 1.02; 95% CI 1.01–1.03; P = 0.003) and neonates being large for their gestational age (AOR 3.02; 95% CI 1.23–7.43; P = 0.016). Conclusions The primary complication arising from assisted vaginal delivery was postpartum haemorrhage. Associated factors were a prolonged second stage of labour, foetal distress, large-for-gestational-age neonates and elevated maternal weight. Cervical and labial injuries correlated with neonates being large for their gestational age. Notably, puerperal infections were related to maternal anaemia (haematocrit levels < 33%). Clinical trial registration Thai Clinical Trials Registry: 20220126004

Prevalence of asymptomatic bacteriuria among Thai diabetic pregnant women

Diabetic pregnant women are susceptible to urinary tract infection, which can result in preterm labor and a low birth weight of the neonate. This was a prospective observational study. In total, 110 diabetic pregnant women between 12–20 weeks of gestation were recruited. Asymptomatic bacteriuria (ASB) was diagnosed when the urinalysis presented a white blood cell (WBC) count ≥ 5 WBCs per high power field (HPF). Urine culture was later performed. Most of the diabetic pregnant women were classified as GDM A1. The prevalence of ASB was 7.2% (8/110 cases). Klebsiella aerogenes was found in only one case from urine culture. ASB was commonly found in the pregnant women with a high BMI, with statistical significance. The prevalence of ASB in the diabetic pregnant women was 7.2%. Urinalysis should be considered for diabetic pregnant women with a high body mass index. (Afr J Reprod Health 2021; 25[5]: 133-139)