Digital fetal scalp stimulation during labor to identify fetal hypoxia
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.
NA · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT07035028
This trial will see if a brief digital stimulation of the fetal scalp during labor can improve heart-rate tracings and scalp blood results for babies with suspicious or pathological cardiotocography.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (other) |
| Locations | 2 sites (Madrid and 1 other locations) |
| Trial ID | NCT07035028 on ClinicalTrials.gov |
What this trial studies
When cardiotocography (CTG) shows a suspicious or pathological fetal heart-rate pattern during labor, clinicians perform a brief digital fetal scalp stimulation (dFSS) during a vaginal exam and record the immediate CTG response. Investigators compare those CTG responses with the reference fetal scalp blood (FBS) result, which measures fetal blood gases and pH. The dFSS intervention is short and non-invasive and is tested alongside standard care, with FBS performed as the gold-standard comparator when indicated. The study enrolls term, singleton, cephalic pregnancies at participating Madrid hospitals and tracks whether dFSS leads to improved CTG patterns and normal FBS values.
Who should consider this trial
Good fit: Term (≥37 weeks), singleton, cephalic pregnancies with suspicious or pathological CTG patterns and eligibility for scalp evaluation are the intended participants.
Not a fit: This approach will not be appropriate for patients under 18, those with contraindications to scalp procedures, maternal HIV/hepatitis, or fetuses at increased risk of hemorrhage.
Why it matters
Potential benefit: If successful, dFSS could reduce the need for invasive fetal scalp blood sampling and speed decision-making about interventions during labor.
How similar studies have performed: Previous smaller studies and clinical reports have shown that scalp stimulation can produce fetal heart-rate accelerations, but large direct comparisons with fetal scalp blood sampling are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 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. Exclusion criteria: Under 18 years of age. Contraindication for FBS Uterine dilatation that does not make FBS possible. HIV Hepatitis Fetuses at increased risk of hemorrhage.
Where this trial is running
Madrid and 1 other locations
- Fundación Jimenez Diaz Y Hospital La Zarzuela — Madrid, Spain (RECRUITING)
- Hospital Universitario Sanitas La Zarzuela — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: RAQUEL MAQUEDA, MATRONA
- Email: raquel.maquedamoreno@usp.ceu.es
- Phone: +34 915504800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fetal Hypoxia, Fetal Monitoring, digital fetal scalp stimulation dFSS, fetal monitoring, fetal blood sampling FBS, fetal scalp blood, cardiotocography, umbilical cord blood