Placental fatty acid transfer: a key factor in fetal growth.

The functionality of the placenta may affect neonatal adiposity and fetal levels of key nutrients such as long-chain polyunsaturated fatty acids. Fetal macrosomia and its complications may occur even in adequately controlled gestational diabetic (GDM) mothers, suggesting that maternal glycemia is not the only determinant of fetal glycemic status and wellbeing. We studied in vivo the placental transfer of fatty acids (FA) labeled with stable isotopes administered to 11 control and 9 GDM pregnant women (6 treated with insulin). Subjects received orally ¹³C-palmitic, ¹³C-oleic, and ¹³C-linoleic acids and ¹³C-docosahexaenoic acid (¹³C-DHA) 12 h before an elective caesarean section. FA were quantified by gas chromatography and ¹³C enrichments by gas chromatography-isotope ratio mass spectrometry. The ¹³C-FA concentration was higher in total lipids of maternal plasma in GDM patients versus controls, except for ¹³C-DHA. Moreover, ¹³C-DHA showed a lower placenta/maternal plasma ratio in GDM patients versus controls and a significantly lower cord/maternal plasma ratio. Other FA ratios studied were not different between GDM and controls. A disturbed ¹³C-DHA placental uptake occurred in GDM patients treated with diet or insulin, while the latter also had lower ¹³C-DHA levels in the venous cord. The tracer study pointed towards an impaired placental DHA uptake as a critical step, while the transfer of other ¹³C-FA was less affected. Patients with GDM treated with insulin could also have a greater fetal fat storage, which may have contributed to the reduced ¹³C-DHA in the venous cord observed. The DHA transfer to the fetus was reduced in GDM pregnancies compared to controls. This might have an influence on fetal neurodevelopment and long-term consequences for the child.

Cook's balloon versus dinoprostone for Labour induction of term pregnancies with fetal GROWth restriction: study protocol for a randomised controlled trial in tertiary maternity hospitals in Spain (COLIGROW study).

INTRODUCTION: Fetal growth restriction (FGR) affects about 3%-5% of term pregnancies. If prenatally detected and anterograde umbilical artery flow is preserved (stage I), it is recommended to deliver at term (≥ 37+0 weeks). In the absence of contraindications, the vaginal route is preferred, and labour induction is usually required. It has been postulated that mechanical methods for cervical ripening may have an optimal profile for the induction of term FGR fetuses since they are associated with less uterine stimulation than the standard pharmacological methods, and therefore, could be better tolerated by fetuses with reduced placental reserve. This study aims to evaluate whether cervical ripening with a Cook's balloon for the induction of labour from 37+0 weeks of gestation in the stage I FGR manages to increase the rate of vaginal delivery compared with vaginal dinoprostone. METHODS AND ANALYSIS: This will be an open-labelled, randomised, parallel-group clinical trial to be held in five Spanish maternities. Women aged ≥18 years with singleton pregnancies complicated with stage I FGR (defined as the presence of at least one of these two criteria: (1) estimated fetal weight (EFW) <3rd percentile; (2) EFW <10th percentile and at least one of the following: (2.1.) umbilical artery pulsatility index >95th percentile and presence of antegrade end-diastolic flow or (2.2.) Cerebroplacental ratio <5th percentile), gestational age dated by first-trimester ultrasound ≥37+0 weeks at the time of labour induction, cephalic presentation, unfavourable cervix (Bishop score <7), intact fetal membranes, no previous caesarean section and no maternal or fetal contraindications for vaginal delivery or labour induction will be 1:1 randomised by centre to labour induction with Cook's balloon (experimental arm) or dinoprostone (control arm). FGR cases with evidence of non-placental origin (major structural fetal malformations, chromosomal anomalies or congenital infection) will be excluded. The primary outcome is the achievement of a vaginal delivery and it will be assessed by comparing the rates of vaginal delivery in each group using the one-sided χ2 test at an alpha level of 0.025. The sample size has been estimated to observe an expected 84% of vaginal deliveries with Cook's balloon vs 62% with dinoprostone. Therefore, a total of 172 patients (86 per arm) are required (power of 90%, alpha level of 0.025, assuming a percentage of losses of 5%). The efficacy analysis will be performed in the intention-to-treat population. An interim analysis using a two-stage sequential design with the O'Brien-Fleming method will be applied. ETHICS AND DISSEMINATION: The trial was registered in the European Union drug regulating authorities' clinical trials database (EUDRACT) (2021-001726-22) and received approval from the local Research Ethics Committee (21/728) and the Spanish Agency of Medicines and Medical Devices (AEMPS). AEMPS classified the study as a low-intervention trial. The study will be conducted in compliance with the principles of Good Clinical Practice. The study results will be disseminated through workshops and national/international conferences and published in peer-reviewed journals. In addition, they will be disclosed to patients and the public in understandable language through study newsletters and press releases to news and social media. PROTOCOL VERSION: V.1.1, 18 May 2023. TRIAL REGISTRATION NUMBERS: EUDRACT 2021-001726-22 and NCT05774236.

Acceptability, tolerability, and effects on symptoms and signs of vulvovaginitis of a non-soap, herbal-based intimate hygiene solution (Zelesse®).

OBJECTIVE: To evaluate the acceptability, tolerability, and effects on vulvovaginitis symptoms and signs of a non-soap, herbal-based intimate solution (Zelesse®). METHODS: We conducted a prospective, observational, multicenter study including adult women with symptoms and signs of vulvovaginitis with various etiologies, including candidiasis, trichomoniasis, bacterial vaginosis, and atrophic and irritative vaginitis. The presence and intensity of signs (edema, erythema, vaginal discharge) and symptoms (pruritus) of vulvovaginitis were evaluated before and after 5-15 days of daily use of Zelesse® alone or as a coadjuvant in antimicrobial therapy. Variables following a normal distribution and categorical variables were analyzed using the Student t-test and chi-square or Fisher's exact test, respectively. RESULTS: A total 137 women were enrolled in the study; 87 (63.5%) women received concomitant antimicrobials and 50 (36.5%) used Zelesse® only. Global symptom scores and frequency of patients with vulvovaginitis signs and symptoms, and their mean intensity, decreased after treatment in both patient groups. Vaginal pH and (in the Zelesse®-only group) vaginal flora remained unaltered. The product was safe, well tolerated, and highly accepted by patients. CONCLUSIONS: Zelesse®, the non-soap herbal-based solution in this study, may represent a safe and effective option for symptomatic relief of vulvovaginitis.

Reliability of examining the external iliac artery with Doppler ultrasound in the first trimester and its relationship with maternal blood pressure and uterine artery blood flow.

OBJECTIVE: To explore the reliability of examining the external iliac artery (EIA) at 11+0 to 13+6 weeks of gestation with Doppler ultrasound and its relationship with maternal characteristics and uterine artery blood flow. STUDY DESIGN: Cross-sectional study of 451 pregnant women undergoing an ultrasound scan in the first trimester. Mean pulsatility index (PI) of both EIAs was correlated to maternal characteristics (maternal age, parity, body mass index and mean arterial blood pressure (MAP)) and ultrasound parameters (crown-rump length (CRL) and mean uterine artery PI). Mean EIA-PI was logarithmically transformed to perform multiple linear regression analysis. The intra- and inter-observer reproducibilities of EIA-PI were examined. RESULTS: Satisfactory flow velocity waveforms were obtained from both EIA in all patients. There is a significant negative correlation between mean EIA pulsatility index and maternal blood pressure. Multiple linear regression analysis showed an independent contribution of MAP to log EIA-PI (mean) (standardized regression coefficient = -0.20, 95% CI: -0.005 to -0.002). The intra-class correlation coefficients (ICCs) for intraobserver and interobserver reproducibility were 0.94 (95% CI, 0.88-0.97) and 0.87 (0.76-0.94) respectively. CONCLUSIONS: Examining blood flow in the external iliac artery using Doppler ultrasound in the first trimester is feasible and reproducible. There is a negative correlation between mean EIA-PI and maternal blood pressure.