Evaluation of Fetal Response to Intrapartum Digital Fetal Scalp Stimulation Upon Detection of Suspected Loss of Fetal Well-being in Suspicious and Pathologic Cardiotocographic Recordings, to Identify Intrapartum Fetal Hypoxia.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The main objective of this study is to evaluate whether digital fetal scalp stimulation improves fetal well-being in fetuses with suspicious or pathological cardiotocographic recordings, showing an improvement in cardiotocographic recording patterns and normal values in intrapartum fetal scalp blood results. Upon detection of a suspicious or pathologic cardiotocographic recording, the investigators need to perform an objective verification of fetal well-being. Currently, fetal scalp blood is the reference test to assess intrapartum fetal hypoxia, according to the protocols of the Spanish Society of Gynecology and Obstetrics. This procedure lasts about 5 minutes and consists of taking a small sample of the fetal scalp, through a vaginal exploration, the blood is collected in a thin tube and analyzed by a machine in the delivery room obtaining the results in a few minutes. The investigators emphasize that this test is not part of the study, as long as the monitor is suspicious or pathological, it will be performed according to protocol to objectively assess fetal well-being. Currently there are studies that support the use of fetal scalp stimulation as an alternative technique to assess intrapartum fetal well-being and predict neonatal outcomes, but they also highlight its limited evidence. Digital fetal scalp stimulation is a NON-invasive method, as no instrument is required and fetal stimulation is a 30-60 second surface rubbing pressure, which is performed manually, through vaginal exploration, the same technique the investigators use to assess dilation during the labor process. Each patient will be randomly assigned to a study group: Experimental group: before the extraction of capillary blood from the fetal scalp, fetal head stimulation will be performed, a technique that poses no risk to the baby. The researchers need the consent of the participants to perform this technique and collect data. Control group: fetal head stimulation will not be applied, but data from the clinical history necessary for this study will be collected. In no case will extraordinary or unnecessary tests be performed for participation in this study. This study will have an Informed Consent document. This study will be carried out at the Fundación Jiménez Díaz and Zarzuela and will include 182 patients for 24 months.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Women with singleton pregnancy.

• Cephalic presentation.

• Gestational age greater than or equal to 37 weeks.

• Pathological cardiotocographic record according to the criteria published by FIGO and with indication to perform a second-line complementary test, in our case a gold standard test of fetal scalp blood FBS, which confirms or not if there is a risk of loss of fetal well-being and the need for fetal extraction.

• Signature of HIP and CI for data collection.

Locations
Other Locations
Spain
Fundación Jimenez Diaz Y Hospital La Zarzuela
RECRUITING
Madrid
Hospital Universitario Sanitas La Zarzuela
RECRUITING
Madrid
Contact Information
Primary
RAQUEL MAQUEDA, MATRONA
raquel.maquedamoreno@usp.ceu.es
+34 915504800
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 182
Treatments
Experimental: digital fetal scalp stimulation dFSS
Digital fetal scalp stimulation will be performed for a period of 30 seconds prior to obtaining the fetal blood sample. Digital fetal scalp stimulation will be performed by vaginal touch with a gauze pad and applying rubbing pressure over the fetal scalp for 30 to 60 seconds. This procedure will be recorded on the same RCTG. The FHR pattern on the cardiotocographic recording is closely monitored for 1 to 10 minutes, using a 5-minute mean, following fetal stimulation the fetus should respond with an acceleration of FHR defined as an increase in FHR ≥ 15 bpm (beats per minute for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of an acceleration of FHR or an increase in variability when it was previously reduced, or both, is interpreted as a positive response, comparable to a normal fetal blood scalp sample FBS result.
No_intervention: NO digital fetal scalp stimulation dFSS
The fetal blood sampling will be performed, since in our environment it is the gold standard method included in the SEGO recommendations.~There is NO intervention.
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Hospital Universitario Sanitas La Zarzuela, CEU San Pablo University

This content was sourced from clinicaltrials.gov