Clinical Research Directory

Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs

Drug overdose is a national crisis. The primary cause of death associated with opioids is opioid-induced respiratory depression. Naloxone (Narcan) which is the first line of defense for opioid overdose can reverse OIRD (Opioid-Induced Respiratory Depression), but in post-operative patients it will abolish pain control. There are no medications that can prevent OIRD. Pre-clinical studies provided evidence that intranasal (administered via a nasal spray) oxytocin may prevent and treat OIRD without interfering with pain control.

Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor

Oxytocin is a key hormone that regulates uterine contractions during labor. Dural Puncture Epidural Analgesia (DPEA) is a modern technique for labor pain relief that provides faster onset and more reliable analgesia than standard epidural.While it is known that neuraxial analgesia can suppress oxytocin levels, it is unclear whether this effect depends on the stage of labor at which analgesia is administered. This prospective comparative study will enroll 120 pregnant women in spontaneous labor who request DPEA, divided into two groups: Early group (cervical dilation≤5 cm, n=60) and Late group (cervical dilation≥6 cm , n=60). Both groups receive identical DPEA (a total volume of 15 mL containing 0.1% bupivacaine and 100 µg fentanyl is administered through the epidural catheter, following dural puncture with a 26G spinal needle without intrathecal drug injection). The primary outcome is the percentage change in plasma oxytocin from baseline (T-0, before analgesia) to T-Eff (30 minutes after onset of effective analgesia defined as VAS\<2). Patients who received any exogenous oxytocin (induction or augmentation) before T-0 are excluded to ensure that the measured oxytocin represents endogenous production. The study will contribute to understanding how the timing of neuraxial analgesia relative to labor progression affects the endogenous oxytocin system, with potential implications for optimal clinical timing of labor analgesia administration.

The Stimulation To Induce Mothers Study

The investigators propose a parallel group randomized clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The central hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery, improves patient-centered outcomes such as childbirth satisfaction, labor agentry, and pain scores, and reduces adverse neonatal and maternal outcomes in nulliparous women. The investigators will pursue the following specific aims: 1) Assess the effectiveness of intrapartum nipple stimulation on the rate of spontaneous vaginal delivery in nulliparous women, 2) Breastfeeding as the sole source of nutrition at time of maternal hospital discharge (Primary Aims); 3) Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life, 4) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes, 5) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes and 6) In a sub-cohort of women who are enrolled in the trial, investigators will measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern.

Potential Benefits of Sonic Augmentation Technology in Music

The goal of this clinical trial is to explore possible benefits and mechanisms through which listening to music enhanced with Sonic Augmentation Technology (SAT) can improve health and wellness. The main goals of the study are: * To examine the immediate effects of listening to the augmented music. * To identify individual characteristics that influence the immediate effects of listening to the augmented music. Participants will: * Complete the online pre- and post-surveys. * Provide pre- and post- music saliva samples (1.5mL). * Listen to the full 15-minutes music session via over-ear headphones.

Oxytocin for Weight Loss in Adolescents

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.

Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss

The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth. The main question this study aims to answer is: Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin? Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups. Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered. In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery. Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.

Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).

The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia

The aim of this study is to determine the influence of oxytocin on fetal well-being during labor in patients receiving epidural analgesia (ELA) with the use of cardiotocography (CTG) and doppler ultrasonography. CTG is a commonly used technique to monitor the fetal heartbeat and contractions of uterus during pregnancy and labor. The maternal-fetal doppler ultrasonography is a non-invasive method used for the pregnancy surveillance. Various psychological and psychosocial factors impact the perception of labor pain. Its intensity is described differently by each patient - some claim it to be the worst pain that they experienced during their lives. Usually, the labor pain is more severely experienced by the patients giving birth for the first time and those with induced labor. Nowadays, there are many non-pharmacological (e.g. acupuncture, massage, TENS) and pharmacological (anesthetic gas, opioids, ELA) methods of labor pain management. ELA is a regional anesthesia, in which the anesthetic drug is injected into the epidural space with the aim to block the pain experienced by the patient without impacting patients ability to move or push during labor. The safety of the procedure is well-discussed and documented in Cochrane review from 2018, which shows no adverse impact on the proportions of Caesarean section, long-term backache, or neonatal outcomes. It is considered to be a golden standard for labor pain management. Oxytocin is a well-known hormone used for the induction of labor and to stimulate the uterine contraction during labor. The impact of oxytocin alone on CTG pattern and maternal-fetal doppler ultrasonography is discussed in the literature. However, the cumulative effect of ELA and oxytocin remains unclear. Some researchers claim that ELA increases the frequency of uterine contractions and that the additional use of oxytocin leads to higher risk of uterine hyper-stimulation and unreassuring CTG patterns. Whereas the others state that ELA weakens the strength of uterine contractions leading to slow progression of labor and the need to use or increase the use of oxytocin. There are no data on how the cumulative use of oxytocin and ELA impacts the maternal-fetal flows during labor.