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

RecruitingNAAges 18 Years - 50 YearsFemaleInstituto de Investigación Sanitaria de la Fundac…
NCT07035028 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 investig

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📋 Eligibility rules (as published)
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.
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What it tests

  • Digital fetal scalp stimulation dFSS
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Where

2 sites
Fundación Jimenez Diaz Y Hospital La Zarzuela
Madrid, Spain
Hospital Universitario Sanitas La Zarzuela
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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