Protocol No: ECCT/21/06/11 Date of Protocol: 15-10-2020

Study Title:

The use of Fetal Pulse Oximetry in determining fetal wellbeing during labour: A non-randomized clinical trial

 

Study Objectives:

Primary Objective: To evaluate the use of an intrauterine fetal pulse oximeter device in comparison to other methods of fetal monitoring in determining fetal well-being in labour.

Secondary Objectives.

  • To evaluate the value of fetal oxygen determination in the second stage of labor?
  • To assess the possibility of a true predictive value of the 60% critical threshold value and whether it will always be associated with pathological CTG/cord blood gases?

 

Laymans Summary:

Accurate monitoring of fetal well being during the labor process is a challenging process. Various monitoring methods currently in use have various shortcoming and are not able to provide a good prediction of the baby outcomes. This led to the development of the fetal pulse oximeter to try bridge thhese shortcomings. By directly measuring the oxygenation status of the baby during the labor process, we hope to detect fetal compromise early and this can be a good adjunct to the available methods of fetal monitoring in labor. 

 

Abstract of Study:

No previous study of fetal pulse oximetry has accurately determined intrapartum fetal oxygenation. We describe a trial for the use of a novel type of fetal pulse oximetry device that, while in labor, touches the fetal presenting part in a non-invasive way, reads the fetal oxygen content and stores the data so the results are masked to those attending the parturient, allowing labor to be managed without prejudice. 

This will be a non-randomized clinical trial. The results of the novel fetal oximeter readings, once unmasked, will be compared to the clinically acceptable measures of fetal wellbeing in labor in our unit, that is, cardiotocogram (CTG) and scalp stimulation test in labor in guiding labor management choices, predicting cord blood gas results at delivery of the fetus and fetal outcomes.

The hypothesis is that the use of this novel pulse oximeter device will be an acceptable clinical comparison to other methods of determining fetal well-being in labor.