Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT07035028

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

Led by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Updated on 2025-06-24

182

Participants Needed

2

Research Sites

100 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Lead Sponsor

C

CEU San Pablo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with a single pregnancy
  • Baby positioned head down (cephalic presentation)
  • Pregnancy of 37 weeks or more
  • Suspicious or pathological cardiotocographic record indicating need for fetal scalp blood test
  • Signed informed consent for participation and data collection
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Contraindications for fetal scalp blood sampling
  • Cervical dilation insufficient for fetal scalp blood sampling
  • Infection with HIV
  • Infection with hepatitis
  • Fetuses with increased risk of hemorrhage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Fundación Jimenez Diaz Y Hospital La Zarzuela

Madrid, Spain, 28040

Actively Recruiting

2

Hospital Universitario Sanitas La Zarzuela

Madrid, Spain

Actively Recruiting

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Research Team

R

RAQUEL MAQUEDA, MATRONA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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