Digital fetal scalp stimulation during labor to identify fetal hypoxia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dual-system transvaginal fetal pulse oximetry

  This tests a transvaginal fetal pulse oximetry sensor to collect fetal oxygen saturation and pulse waveforms from women in labor to help develop signal-processing algorithms.

  Recruiting Raydiant Oximetry, Inc. · Shreveport, Louisiana · NCT07296419

• Virtual reality versus in-person progressive muscle relaxation for pregnant people with preeclampsia

  This trial will test whether virtual reality–guided progressive muscle relaxation or face-to-face progressive muscle relaxation better reduces stress and improves maternal and fetal outcomes in hospitalized pregnant people with preeclampsia at or after 26 weeks.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT06893510

• Keeping the umbilical cord intact during resuscitation after emergency cesarean delivery

  This will test whether keeping the umbilical cord attached for 3–5 minutes during resuscitation helps term babies born by emergency C-section who aren't breathing.

  Recruiting at 12 sites Region Skane · Gothenburg and 11 other locations · NCT06540222

• Oxygen supplementation for mothers during labor to help babies in distress

  This study is testing if giving extra oxygen to mothers during labor can help their babies who are in distress feel better and avoid complications.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT05681624

• Capturing fetal heart activity using ECG technology

  This study is testing if a special heart monitor can accurately capture a baby's heartbeat in pregnant women who are 32 weeks along or more.

  Recruiting University of Washington · Seattle, Washington · NCT03111173

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.