Clinical Research Directory

Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor

This is a pilot randomized, triple-blind clinical trial (pilot RCT) evaluating the preliminary effects of energy supplementation with carbohydrate-rich sports gels compared to a low-sugar sports drink during labor in low-risk pregnant women receiving epidural analgesia. Labor is associated with substantially increased metabolic demands, while current evidence on intrapartum carbohydrate supplementation remains heterogeneous. This study investigates whether a carbohidrate solution formulation containing improves maternal and neonatal outcomes compared to an other. A total of 142 term, low-risk pregnant women will be recruited at a single hospital center and randomized to receive either the sports gel or the control beverage. The intervention will begin 60 minutes after epidural analgesia and be repeated every 3 hours until delivery, with a maximum of 4 units administered per participant. The primary objective is to obtain preliminary estimates of the intervention effects on labor duration and obstetric and neonatal outcomes. Secondary outcomes include cardiotocography patterns, maternal and neonatal glucose levels, postpartum hemorrhage, vomiting episodes, and maternal satisfaction. This trial was prospectively registered. The study was initially conceived as a pilot randomized controlled trial within an institutional research framework, and registration was completed after participant recruitment had been completed to ensure transparency and adherence to international reporting standards. The results of this pilot study will inform the design of a future large-scale randomized controlled trial.

Improvings: Implementing a Protocol to Improve Intrapartum Sonography Skills.

Prospective observational cohort study on the learning curve for the sonographic assessment of labor progress (fetal head position and station) amongst obstetric caregivers. Study participants: convenience sample of 20 obstetric caregivers working in the department of obstetrics and gynecology at the University Hospital of Leuven - recruited over a 12-month period. Format of the training program: 1. Observational phase: the goal is to measure the accuracy of the clinical assessment of fetal head position and station throughout the different stages of labor by caregivers working within the department. 2. Self-study: reading of the 2018 practice guidelines on intra-partum ultrasound by ISUOG and watching the corresponding teaching video. 3. Supervised implementation phase: one-to-one teaching by experienced sonographers, who initially demonstrate, later interactively supervise the quality of the scans acquired by the obstetric caregiver. 4. Proficiency testing: from this point onwards, the trainee independently performs ultrasound scans in labor to asses fetal head position and station. The scans will be repeated by the expert sonographer, the results will be compared (qualitatively and quantitatively) and immediate feedback provided if indicated. Every observation will have a binary outcome (success or failure of trainee acquisition) according to predefined quality assessment criteria. Observations will be continued until proficiency is reached (saturation of the learning curve).

Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.