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Fetal Hypoxia clinical trials

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NCT ID: NCT06405984 Recruiting - Oxygen Deficiency Clinical Trials

Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

Start date: April 15, 2024
Phase: Early Phase 1
Study type: Interventional

The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.

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: NCT04876846 Recruiting - Fetal Hypoxia Clinical Trials

Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity

Start date: April 24, 2021
Phase: N/A
Study type: Interventional

The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters, the calculations will be integrated into software in the final commercial product; (ii) obtain human measurements against which both computational models and animal data can be compared.

NCT ID: NCT01533701 Recruiting - Fetal Hypoxia Clinical Trials

Scalp Sampling for Fetal Surveillance

FBS
Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare lactate and total acid-base status in fetal scalp blood with lactate and total acid-base status in maternal blood and amniotic fluids to provide information on how lactate and base deficit correlates with scalp samples. Furthermore, the investigators want to study whether angiogenic factors in fluids above may be a possible marker of asphyxia during labor.