Evaluation of the Fetal Response to Intrapartum Digital Fetal Scalp Stimulation to Identify Intrapartum Fetal Hypoxia.

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.

Conditions

• Fetal Hypoxia
• Fetal Monitoring

Interventions

DIAGNOSTIC_TEST

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 rubbing the fetal scalp with pressure for 30 to 60 seconds.

Sponsors & Collaborators

• CEU San Pablo University

  collaborator OTHER

• Hospital Universitario Sanitas La Zarzuela

  collaborator OTHER

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  lead OTHER

Principal Investigators

• JAVIER PLAZA ARRANZ, Doctor · Hospital Fundación Jiménez Diaz

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Spain

Study Locations