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Fetal Distress clinical trials

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NCT ID: NCT06186973 Recruiting - Labor Pain Clinical Trials

Fetal Assessment of the Myocardium and Evaluation of the Neonate

FAME-n
Start date: November 14, 2022
Phase:
Study type: Observational

FAME-n aims to improve perinatal care by introducing new approaches to fetal and neonatal heart assessment. Better identification of high-risk deliveries requiring intervention will reduce perinatal asphyxia-related illness and death. Neonatal hemodynamics may be improved by early detection of instability of the heart and circulation. Innovative use of technology enables characterization of normal and abnormal cardiovascular transition in a significantly larger number of fetuses and newborn infants than what was previously possible. The methods used may have broad generalizability and applicability in perinatal, neonatal and pediatric medicine. In September 2023, the project was expanded with an obstetric arm called Epidural analgesia: Fetal Oxygenation and Maternal Oxygenation (Epi-FOMO). In Epi-FOMO, the relationship between maternal breathing and arterial blood gases during labour, and umbilical cord blood gases and neonatal outcomes (as specified in FAME-n) will be investigated.

NCT ID: NCT05946681 Recruiting - Stillbirth Clinical Trials

Sildenafil Citrate to Improve Maternal and Neonatal Outcomes in Low-resource Settings

PRISM
Start date: May 16, 2023
Phase:
Study type: Observational

The PRISM pilot feasibility study consists of two phases to determine: 1) to delivery practices, rates of primary and secondary outcomes, and feasibility of enrollment rates, and 2) to assess the feasibility and acceptability of the intervention and expected enrollment rates, and estimate the effect size of sildenafil citrate on maternal and neonatal outcomes in a low resource settings in preparation for the main RCT.

NCT ID: NCT05729750 Completed - Clinical trials for Fetal Status, Nonreassuring

Efficacy of Music Listening to Shortening Time for Biophysical Profile

RRT
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the timeing which assume for assesment of BPP in low risk pregnancy. The main question is the music can be shoetening the timing for BPP? Participants will in study froup will listening the music via headphone before and during the assessment and compre to control gruop which not listening to music during asseeement.

NCT ID: NCT05727241 Not yet recruiting - Clinical trials for Intrauterine Growth Restriction

Three-dimensional Umbilical Cord Coiling Index

Start date: July 1, 2023
Phase:
Study type: Observational

Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death. The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.

NCT ID: NCT05681624 Recruiting - Fetal Distress Clinical Trials

Maternal Oxygen Supplementation for Intrauterine Resuscitation

MOXY
Start date: May 22, 2023
Phase: N/A
Study type: Interventional

More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor & Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor & Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.

NCT ID: NCT05558176 Recruiting - Foetal Hypoxia Clinical Trials

Intrapartum Sildenafil Citrate to Prevent Non Reassuring Foetal Status Among Parturients Delivering at Term

Start date: April 8, 2022
Phase: Phase 4
Study type: Interventional

Background: Intrapartum non-reassuring foetal status is a global challenge. It is a key contributor to operative deliveries. In low- and middle-income countries, it is a major cause of perinatal deaths, hypoxic ischemic encephalopathy, and cerebral palsy. Through its vasodilatory action and by improving uteroplacental perfusion, intrapartum sildenafil citrate could reduce the risk of intrapartum foetal compromise. Aim: To determine the effect of intrapartum Sildenafil citrate on the prevention of non-reassuring foetal status among parturients delivering at term. Specific Objectives: 1. To determine the frequency of non reassuring foetal heart rate (FHR) pattern among parturients delivering at term following administration of intrapartum Sildenafil citrate compared with placebo 2. To determine the rate of Caesarean delivery for non-reassuring FHR following the administration of intrapartum Sildenafil citrate compared with placebo. 3. To determine the rate of instrumental delivery for non-reassuring FHR following the administration of intrapartum Sildenafil citrate compared with placebo 4. To determine the effect of Sildenafil citrate on uteroplacental blood flow compared with placebo. 5. To determine if Sildenafil citrate is associated with an improved APGAR score at 5th minute compared with placebo. Methodology: Study Design: Double blind randomised controlled trial. Women at term in early labour or undergoing scheduled induction of labour will be randomly allocated to receive 50 mg of sildenafil citrate or placebo orally once admitted in labour 6 hourly up to a maximum dose of 150 mg. Intrapartum foetal monitoring will be done by continuous cardiotocogragh, labour will be monitored with the aid of partograph following the departmental protocol for conduct of labour. Planned Handling of Results: Obtained data will be analyzed using IBM (International Business Machines Corporation) SPSS (Statistical Product and Service Solutions) version 21, taking level of significance as p-value <0.05. Categorical variables will be expressed as percentages and presented using frequency tables and charts. The chi-square test will be used to test for association between categorical variables. Continuous variables will be presented as mean or median. Differences between continuous variables will be compared with the Student t test.

NCT ID: NCT05326269 Completed - Clinical trials for Nonreassuring Fetal Status

Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Start date: April 23, 2017
Phase: N/A
Study type: Interventional

The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress

NCT ID: NCT05306756 Terminated - Clinical trials for Intrapartum Fetal Distress

Fetal Scalp Stimulation Versus Fetal Blood Sampling in Labour

FIRSST
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

Pregnant women have routine monitoring of the baby's heart rate when in labour. Women with complicated pregnancies require continuous monitoring using an electronic recorder called a CTG. The CTG produces a paper based recording which is interpreted by the midwife as showing normal, suspicious or abnormal features of the baby's heart rate. Babies quite commonly demonstrate abnormal features from time to time during the course of labour. In some cases the abnormal features are of sufficient concern to warrant delivery by emergency caesarean section. In most of these cases the baby is born in good condition and the question arises whether the caesarean section was unnecessary. In order to reduce the chance of an unnecessary caesarean section additional "second-line" tests can be offered. One such test is where a small drop of blood is taken from the baby's scalp. This test involves an internal examination with an instrument to visualise the baby's head and a small scratch to the baby's scalp. The blood is tested for acid which is an indicator of whether or not the baby is receiving enough oxygen. The test is called a fetal blood sample or FBS. An alternative test is where the doctor or midwife performs a vaginal examination with two fingers and gently rubs the baby's scalp in an attempt to cause an increase in the baby's heart rate. This is a healthy response suggesting that the baby is receiving enough oxygen. The test is called digital fetal scalp stimulation or dFSS. These two "second-line" tests have never been compared in a properly conducted head-to-head comparison. This study aims to compare dFSS and FBS in a large clinical trial completed within four of Ireland's largest maternity hospitals. This trial will generate important evidence of direct relevance to clinical care and patient outcomes.

NCT ID: NCT05147584 Terminated - Fetal Distress Clinical Trials

Trans-abdominal Fetal Pulse Oximetry

Start date: July 20, 2022
Phase: N/A
Study type: Interventional

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

NCT ID: NCT04986475 Completed - Anxiety Clinical Trials

Music Therapy on High Risk Pregnant Women of Non-Stress Test

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Non-stress testing (NST) is one of the most commonly used methods to assess fetal health in the prenatal period because it is an easily interpreted, non-invasive, painless, and short-term diagnostic method. Although NST is a non-invasive and painless diagnostic method, pregnant women may feel anxiety during the procedure. It is supported by studies that listening to music causes relaxation and reducing anxiety. Therefore, the use of music as a non-pharmacological practice will increase the quality of care of individuals. There are many studies suggesting that music reduces anxiety in low-risk pregnancies during NST application. Different instruments such as ney, rebab, kopuz, dombra are used in Turkish music. In particular, ney has come to the fore in music therapy. The ney, which has different types in history, is an instrument that is closest to the human voice. In a compilation about the music used in music therapy in Turkey, it was stated that there are many social and health studies made with the sound of ney. Determining the effect of music on NST and anxiety in high-risk pregnant women will contribute to the literature.