CLINICAL TRIAL

Dual fetal oxygen sensors for Fetal or Neonatal Effect of Complication of Labor

Waitlist Available · 18+ · Female · Galveston, TX

Trans-abdominal Fetal Pulse Oximetry

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About the trial for Fetal or Neonatal Effect of Complication of Labor

Eligible Conditions
Fetal or Neonatal Effect of Complication of Labor · Hypoxia · Fetal Hypoxia · Fetal Acidemia · Obstetric Labor Complications · Fetal Distress

Treatment Groups

This trial involves 2 different treatments. Dual Fetal Oxygen Sensors is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Dual fetal oxygen sensors
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Willing and capable to provide informed consent
Age > 18 years
BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)
Gestational age > 36 weeks
Singleton pregnancy
Vertex presentation
Active labor Category I or Category II tracings
Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: During labor
Screening: ~3 weeks
Treatment: Varies
Reporting: During labor
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: During labor.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Dual fetal oxygen sensors will improve 2 primary outcomes in patients with Fetal or Neonatal Effect of Complication of Labor. Measurement will happen over the course of During labor.

Fetal oxygen levels
DURING LABOR
Concurrence of internal and external fetal oxygen sensors
DURING LABOR
Adverse events
DURING LABOR
Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum. Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.
DURING LABOR

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been other clinical trials involving dual fetal oxygen sensors?

Although the procedure is relatively simple and inexpensive, the high cost of medical expenses needs to be considered as a disadvantage. At present, we believe that it is not practical to use the process of simultaneous fetal oxygen monitoring for clinical trials.

Anonymous Patient Answer

Can fetal or neonatal effect of complication of labor be cured?

The effect of complication of labor with or without fetal or neonatal asphyxia may be cured by the timely delivery of vaginal or caesarean births.

Anonymous Patient Answer

How many people get fetal or neonatal effect of complication of labor a year in the United States?

The prevalence of all neonatal and fetal effects is lower than reported because most neonatal and fetal effects were not reported in many national or regional pregnancy registries. Many countries have developed programs to improve their surveillance and reporting of pregnancy complications.

Anonymous Patient Answer

What causes fetal or neonatal effect of complication of labor?

Although some of the causes can be identified during labor, many more were not known, including infectious and non-infectious maternal and fetal complications. Therefore, all the causes of fetal and neonatal effect of labor should be considered. This list of causes is based on the results of fetal and neonatal studies.

Anonymous Patient Answer

What are the signs of fetal or neonatal effect of complication of labor?

Abrupt fetal death was the most common fetal sign of labor complication. The combination of fetal apnea and vaginal hemorrhage was the most common neonatal sign.

Anonymous Patient Answer

What is fetal or neonatal effect of complication of labor?

Maternal medical, socioeconomic, and demographic characteristics were significantly different between those delivering at term vs preterm. The presence of a history of post-traumatic stress disorder or the history of a severe mood disorder were associated with higher odds of delivering preterm.

Anonymous Patient Answer

What are common treatments for fetal or neonatal effect of complication of labor?

Women without any fetal or neonatal effect have a 1.7 to sixfold greater risk of postpartum lupus than women with either adverse outcome. Because fetal and neonatal effects are rare, and may persist after delivery, an association with the postpartum development of lupus remains possible.

Anonymous Patient Answer

What is the latest research for fetal or neonatal effect of complication of labor?

In the present study, no research was able to find any difference in outcomes with the usage of labor induction vs. induction by expectant treatment for uncomplicated pregnancies. However, this may be the result of low quality studies. To find a high-quality randomized study, large sample size is required. Also, there are other strategies beyond the induction itself, such as the use of mechanical ventilators and fetal monitoring.

Anonymous Patient Answer

What is the primary cause of fetal or neonatal effect of complication of labor?

The primary cause of fetal and neonatal effect of complication of labor was not determined. Primary causes of fetal and neonatal effect of complication of labor should not be assumed to be pre-eclampsia.

Anonymous Patient Answer

What are the common side effects of dual fetal oxygen sensors?

The data presented support the conclusion that a dual fetal oxygen sensor reduces the risks of intrauterine infection and of the delivery of an infected infant.

Anonymous Patient Answer

What is the average age someone gets fetal or neonatal effect of complication of labor?

There may be a significant racial difference in the incidence of CPL in this population. Further research is needed on the risk factors for CPL, the timing and rate of fetal or neonatal outcome, and the management of labor complicated by CPL to improve patient outcomes and improve cost-effectiveness.

Anonymous Patient Answer

Does dual fetal oxygen sensors improve quality of life for those with fetal or neonatal effect of complication of labor?

Prenatal, non-invasive use of dual fetal oxygen sensors leads to improvement in quality of life in patients with fetal or neonatal ligation of the umbilical cord for complication of labor.

Anonymous Patient Answer
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