NCT07035028 Evaluation of the Fetal Response to Intrapartum Digital Fetal Scalp Stimulation to Identify Intrapartum Fetal Hypoxia.
| NCT ID | NCT07035028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| Condition | Fetal Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2024-01-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
JAVIER PLAZA ARRANZ, Doctor
STUDY DIRECTOR
Hospital Fundación Jiménez Diaz
Frequently Asked Questions
Who can join the NCT07035028 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Fetal Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07035028 currently recruiting?
Yes, NCT07035028 is actively recruiting participants. Contact the research team at raquel.maquedamoreno@usp.ceu.es for enrollment information.
Where is the NCT07035028 trial being conducted?
This trial is being conducted at Madrid, Spain, Madrid, Spain.
Who is sponsoring the NCT07035028 clinical trial?
NCT07035028 is sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The principal investigator is JAVIER PLAZA ARRANZ, Doctor at Hospital Fundación Jiménez Diaz. The trial plans to enroll 182 participants.