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Fetal Distress clinical trials

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NCT ID: NCT06377098 Not yet recruiting - Development, Infant Clinical Trials

Intrapartum Sildenafil in Laboring Mothers

PRISM
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources. The main questions it aims to answer are: - What are the fetal heart rate monitoring practices in a low-resource setting? - What are the indications for operative delivery in a low-resource? - What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil? - What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting? Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected. Participants will: - Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor - Have the (mothers & babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag & mask ventilation, Apgar scores, and seizures. - Have a neonatal neurological assessment prior to discharge - Have phone call assessments for re-hospitalization or mortality 7 days post-delivery - Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.

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: NCT04548453 Not yet recruiting - Pregnancy Related Clinical Trials

Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions

uSI-ranges
Start date: April 2021
Phase: Early Phase 1
Study type: Interventional

Patients receiving oxytocin for induction or augmentation of labor will be studied with uterine EMG. The results of the EMG will be converted to an oxytocin-associated uterine stimulation index (uSI), which is intended to guide decisions for changing the dose of oxytocin. An expert panel will review the results of the oxytocin dosing actions, then assigned optimized actions throughout the labor. The uSI will be correlated with the optimal dosing actions.

NCT ID: NCT03859037 Not yet recruiting - Fetal Distress Clinical Trials

Effect of Umbilical Cord Milking on Transition of Preterm Babies During Resuscitation

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Investigators will evaluate if milking of umbilical cord in preterm babies will improve transition during resuscitation or not