ClinicalTrials.gg
RecruitingNCT07035028Updated Jun 24, 2025

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

An interventional study of Digital fetal scalp stimulation dFSS in Fetal Hypoxia and Fetal Monitoring, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruiting at 2 sites in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2024, registered May 2025).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the detailed description

The goal of intrapartum care is to ensure excellent maternal and perinatal outcomes. Normal labor is characterized by regular uterine contractions, which cause repeated transient interruptions in fetal oxygenation. Most fetuses tolerate this process well, but some do not. The fetal heart rate (FHR) pattern helps distinguish the former from the latter, as it is an indirect marker of fetal cardiac and central nervous system responses to changes in blood pressure, blood gases, and acid-base status. The term "suspected fetal compromise or risk of loss of fetal well-being" is used in obstetrics, when the fetus is considered to be at increased risk of ischemic hypoxic injury, brain damage or death, and is one of the most common indications for emergency cesarean section during labor. In our setting, continuous electronic fetal heart rate monitoring recorded by cardiotocography (CTG) is routinely used in labor to identify fetuses that may be at increased risk of compromise and may benefit from further evaluation of fetal well-being or other interventions. CTG tracings display the fetal heart rate (FHR) pattern along with maternal uterine activity.

CTG patterns are classified into discrete general categories according to four criteria: basal FHR, heart rate variability, presence or absence of FHR accelerations, and decelerations. An example of such a classification system is the 2015 FIGO International Federation of Gynecology and Obstetrics guideline, on which the investigators will base our study. The Spanish Society of Gynecology and Obstetrics defines the registry in normal, suspicious, and pathologic categories. Regardless of the classification system used, abnormal FHR patterns that do not respond to basic intrauterine resuscitation measures require further evaluation of fetal well-being and/or termination of pregnancy, either by cesarean section, assisted vaginal delivery, or spontaneous vaginal delivery.

CTG has a high false-positive rate for fetal compromise (60%) and the studies of Chandraharan et al are gaining momentum, where intrapartum interventions should be based on a thorough understanding of the features observed on the tracing recordings to differentiate normal fetal response to continued stress from the onset of compensation, so that timely action can be taken to avoid hypoxic ischemic encephalopathy and prenatal deaths, while avoiding unnecessary intrapartum interventions to the mother. Cesarean section rates are increasing worldwide, much of that increase is due to primary cesarean sections among nulliparous women due to emergency procedures in labor. Our great challenge is to achieve a reliable test of fetal well-being during labor and to be able to be minimally invasive for both mother and fetus.

When a suspicious or pathologic FHR pattern is detected and immediate delivery is not warranted, further evaluation of fetal well-being is necessary; such second-line evaluations or tests include fetal scalp blood, in Spain Gold standard to identify fetuses with acidosis and reduce the false positive rate of CTG, and digital fetal scalp stimulation. Clinical guidelines support the use of digital fetal scalp stimulation but also note that research evidence is limited. Digital fetal scalp stimulation is the least invasive method, as it does not require instruments; it involves rubbing the surface of the fetal scalp with pressure for 30 to 60 seconds; the response to stimulation should be evident in cardiotocographic patterns over the next 10 minutes, using a 5-minute average. Fetal scalp stimulation should elicit an acceleration of FHR defined as an increase in FHR ≥ 15 bpm for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of an acceleration of FHR or an increase in variability (when previously reduced), or both, is interpreted as a positive response, comparable to a normal fetal scalp blood pH result greater than 7.20.

Fetal scalp blood sampling is an intrapartum procedure to assess the presence and degree of fetal acidemia by analyzing fetal capillary blood for pH or lactate, as both give similar results, with pH being the gold standard test for fetal acidosis in our setting. An amnioscope with a light source is used to expose the fetal scalp, which is cleaned with a 2% aqueous chlorhexidine gauze from blood, mucosa and amniotic fluid, then the scalp is punctured with a 2 mm blade. The blood is collected in long capillary tubes. The test requires the cervix to be dilated at least 2 to 3 cm, can be difficult to perform and may be uncomfortable for the laboring woman. It is contraindicated when the mother is known to have a serious transmissible infection, such as HIV or hepatitis, and in fetuses at increased risk of hemorrhage. Rare complications described in case reports include infection, hemorrhage and cerebrospinal fluid leakage. The procedure will result in stimulation of the fetus, but the primary intent is to collect a scalp blood that will allow quantitative analysis of fetal pH or lactate, reflecting fetal blood oxygenation.

It is not taken into account that the scalp skin is a nonessential peripheral tissue that undergoes catecholamine-induced vasoconstriction early in the fetal stress response and therefore fetal scalp blood sampling does not reflect oxygenation of the fetal central organs and alkaline amniotic fluid and bile acids from meconium may alter results. It has also been shown that fetal scalp blood has no significant effect on the cesarean section rate in women monitored by continuous cardiotocography. Intrapartum fetal scalp blood sampling to measure pH, base excess or deficit, or lactate has not been clearly demonstrated to reduce emergency cesarean deliveries or operative vaginal deliveries or to improve long-term perinatal outcome.

For this reason and many others, such as quality control problems, cost, patient discomfort, sample failure rates of up to 10% and the lack of availability of sampling kits, fetal scalp blood sampling is only rarely performed in the United States and other countries, which is not currently the situation in Spain, since for the SEGO it continues to be the gold standard for detecting fetal acidosis.

The NICE 2022 guideline conducted a review comparing fetal blood sampling with digital fetal scalp stimulation and noted that the studies conducted to date were of low to very low quality, similar to the Cochrane 2023 review which includes two studies Hughes 2022 and Tahmina 2022 , in which Hughes compares fetal scalp stimulation and cardiotocographic patterns with fetal scalp blood samples and cardiotocographic patterns and Tahmina compares fetal head stimulation and cardiotocographic patterns with no fetal head stimulation intervention. The Hughes study reported an apgar score of less than 7 at 5 minutes, a finding that was not recorded in Tahmina, which reported a lower risk of cesarean section in the fetal scalp stimulation group, but again both studies are of very low quality. Although not included in the NICE or Cochrane review, there are other studies that demonstrate that the effectiveness of fetal scalp stimulation is poor for ruling out or confirming fetal hypoxia during labor.

Therefore, very low certainty evidence is available that makes it unclear whether fetal scalp stimulation is a safe and effective way to confirm fetal well-being during labor. Current studies have limitations. More high quality studies with sufficient sample size are needed to evaluate this research question. There is an ongoing study (FIRSST) that will be added to the NICE review in a later update.

The current project aims to give value to a second tier test with little demonstrated scientific evidence, fetal scalp stimulation.

02

Conditions studied

  • Fetal Hypoxia
  • Fetal Monitoring

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Keywords

  • digital fetal scalp stimulation dFSS
  • fetal monitoring
  • fetal blood sampling FBS
  • fetal scalp blood
  • cardiotocography
  • umbilical cord blood
  • acidemia
  • Intrapartum care
03

In context

Fetal Hypoxia

23 studies on the registry are indexed under Fetal Hypoxia; 6 are open to participants now.

This study's planned enrollment of 182 is above the median of 145 across 18 interventional studies indexed under Fetal Hypoxia.

Browse Fetal Hypoxia studies →

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion criteria:

Under 18 years of age.

for FBS

Uterine dilatation that does not make FBS possible.

Hepatitis

Fetuses at increased risk of hemorrhage.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (estimated)

Study arms

  • Experimental
    digital fetal scalp stimulation dFSS

    Digital fetal scalp stimulation will be performed for a period of 30 seconds prior to obtaining the fetal blood sample. Digital fetal scalp stimulation will be performed by vaginal touch with a gauze pad and applying rubbing pressure over the fetal scalp for 30 to 60 seconds. This procedure will be recorded on the same RCTG. The FHR pattern on the cardiotocographic recording is closely monitored for 1 to 10 minutes, using a 5-minute mean, following fetal stimulation the fetus should respond with an acceleration of FHR defined as an increase in FHR ≥ 15 bpm (beats per minute for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of an acceleration of FHR or an increase in variability when it was previously reduced, or both, is interpreted as a positive response, comparable to a normal fetal blood scalp sample FBS result.

    Diagnostic Test: Digital fetal scalp stimulation dFSS

  • No intervention
    NO digital fetal scalp stimulation dFSS

    The fetal blood sampling will be performed, since in our environment it is the gold standard method included in the SEGO recommendations. There is NO intervention.

Interventions

  • Diagnostic testDigital fetal scalp stimulation dFSS

    Digital fetal scalp stimulation will be performed for a period of 30 seconds, prior to obtaining the fetal blood sample. Digital fetal scalp stimulation will be performed by vaginal touch with a gauze pad and rubbing the fetal scalp with pressure for 30 to 60 seconds.

    Also known as: dFSS

06

What researchers measure

Primary outcomes

  1. Percentage of fetuses with positive response to digital fetal scalp stimulation, intrapartum ph greater than 7.20, newborn ph greater than 7.20 and good neonatal outcomes

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation, obtain an intrapartum pH greater than 7.20, at birth a pH greater than 7.20, and good neonatal outcomes.

    Time frame: 2 years

Secondary outcomes

  1. Differences in the cardiotocographic pattern of fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation

    Significant differences in the cardiotocographic pattern of fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation The FHR pattern in the cardiotocographic recording is closely monitored for 1 to 10 minutes, using a 5-minute mean. Assess an acceleration of FHR defined as an increase in FHR ≥ 15 bpm (beats per minute for at least 15 seconds or normal FHR variability (5 to 25 bpm), or both. The presence of FHR acceleration or increased variability when previously reduced, or both, is interpreted as a positive response.

    Time frame: 2 years

  2. Differences in the results of intrapartum fetal scalp blood of fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Significant differences in intrapartum pH results in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  3. Differences in newborn ph results of fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Significant differences in newborn pH outcomes in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  4. Differences in the first minute apgar scores of the newborns in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Significant differences in the minute-of-life Apgar scores of newborns in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  5. Differences in apgar scores at 5 minutes of life of newborns in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Significant differences in apgar scores at 5 minutes of life of newborns in in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  6. Differences in the results of the type of newborn resuscitation in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Significant differences in results of the type of newborn resuscitation in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  7. Differences in neonatal unit admission rates in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Significant differences in the percentages of admission to the neonatal unit in fetuses with digital fetal scalp stimulations versus fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  8. Differences in newborn seizure percentages in fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation

    Significant differences in newborn seizure percentages in fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  9. Differences in the percentages of newborn deaths in fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation

    Significant differences in percentages of newborn deaths in fetuses with digital fetal scalp stimulation vs. fetuses without digital fetal scalp stimulation

    Time frame: 2 years

  10. Differences in completion of cesarean delivery in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.

    Significant differences in completion of cesarean delivery in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.

    Time frame: 2 years

  11. Differences in instrumental deliveries in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.

    Significant differences in instrumental deliveries in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.

    Time frame: 2 years

  12. Differences in vaginal deliveries in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.

    Significant differences in vaginal deliveries in fetuses with digital fetal scalp stimulation versus fetuses without digital fetal scalp stimulation.

    Time frame: 2 years

  13. Percentage of fetuses with positive response to digital fetal scalp stimulation and intrapartum pH greater than 7.20

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain an intrapartum pH greater than 7.20.

    Time frame: 2 years

  14. Percentage of fetuses with positive response to digital fetal scalp stimulation and intrapartum pH less than or equal to 7.20

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain an intrapartum pH less than or equal to 7.20.

    Time frame: 2 years

  15. Percentage of fetuses with negative response to digital fetal scalp stimulation and intrapartum pH above 7.20.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain an intrapartum pH greater than 7.20.

    Time frame: 2 years

  16. Percentage of fetuses with negative response to digital fetal scalp stimulation and intrapartum pH less than or equal to 7.20.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain an intrapartum pH less than or equal to 7.20.

    Time frame: 2 years

  17. Percentage of fetuses with positive response to digital fetal scalp stimulation and neonatal pH above 7.20.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain a neonatal pH greater than 7.20.

    Time frame: 2 years

  18. Percentage of fetuses with negative response to digital fetal scalp stimulation and neonatal pH above 7.20.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain a neonatal pH greater than 7.20.

    Time frame: 2 years

  19. Percentage of fetuses with positive response to digital fetal scalp stimulation and neonatal pH less than or equal to 7.20.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain a neonatal pH less than or equal to 7.20.

    Time frame: 2 years

  20. Percentage of fetuses with negative response to digital fetal scalp stimulation and neonatal pH less than or equal to 7.20.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain a neonatal pH less than or equal to 7.20.

    Time frame: 2 years

  21. Percentage of fetuses with positive response to digital fetal scalp stimulation and apgar score greater than or equal to 8 in the first minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain a apgar score greater than or equal to 8 in the first minute of life.

    Time frame: 2 years

  22. Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score greater than or equal to 8 in the first minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain a apgar score greater than or equal to 8 in the first minute of life.

    Time frame: 2 years

  23. Percentage of fetuses with positive response to digital fetal scalp stimulation and apgar score less than 8 in the first minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain a apgar score less than 8 in the first minute of life.

    Time frame: 2 years

  24. Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score less than 8 in the first minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain a apgar score less than 8 in the first minute of life

    Time frame: 2 years

  25. Percentage of fetuses with a positive response to digital fetal scalp stimulation and an Apgar score greater than or equal to 8 at five minutes of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain a apgar score greater than or equal to 8 at five minute of life

    Time frame: 2 years

  26. Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score greater than or equal to 8 at five minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain a apgar score greater than or equal to 8 at five minute of life.Time Frame: 2 years

    Time frame: 2 years

  27. Percentage of fetuses with positive response to digital fetal scalp stimulation and apgar score less than 8 at five minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and obtain a apgar score less than 8 at five minute of life.

    Time frame: 2 years

  28. Percentage of fetuses with negative response to digital fetal scalp stimulation and apgar score less than 8 at five minute of life.

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and obtain a apgar score less than 8 at five minute of life

    Time frame: 2 years

  29. Percentage of fetuses with positive response to digital fetal scalp stimulation and type of neonatal resuscitation.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and the type of neonatal resuscitation.

    Time frame: 2 years

  30. Percentage of fetuses with negative response to digital fetal scalp stimulation and type of neonatal resuscitation.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and the type of neonatal resuscitation.

    Time frame: 2 years

  31. Percentage of fetuses with positive response to digital fetal scalp stimulation and requiring admission to the neonatal unit.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and require admission to the neonatal unit.

    Time frame: 2 years

  32. Percentage of fetuses with negative response to digital fetal scalp stimulation and requiring admission to the neonatal unit.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and require admission to the neonatal unit.

    Time frame: 2 years

  33. Percentage of fetuses with a positive response to digital fetal scalp stimulation who seizure

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being who respond positively to digital fetal scalp stimulation and who convulse.

    Time frame: 2 years

  34. Percentage of fetuses with a negative response to digital fetal scalp stimulation who seizure

    To assess the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being who respond negatively to digital fetal scalp stimulation and who convulse.

    Time frame: 2 years

  35. Percentage of fetuses with positive response to digital fetal scalp stimulation and neonatal death.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond positively to digital fetal scalp stimulation and neonatal death.

    Time frame: 2 years

  36. Percentage of fetuses with negative response to digital fetal scalp stimulation and neonatal death.

    To evaluate the percentage of fetuses with suspicious or pathologic cardiotocographic recording patterns compatible with risk of loss of fetal well-being that respond negatively to digital fetal scalp stimulation and neonatal death.

    Time frame: 2 years

07

Study locations

2 of 2 sites recruiting
  • Fundación Jimenez Diaz Y Hospital La Zarzuela
    Madrid, 28040, Spain
    Recruiting
    • RAQUEL MAQUEDA, MATRONA · Contactraquel.maquedamoreno@usp.ceu.es · +34 915504800
    • MIGUEL ALVARO NAVIDAD, DOCTOR · Sub investigator
    • ANA VIRSEDA DE ANTONIO, DOCTOR · Sub investigator
  • Hospital Universitario Sanitas La Zarzuela
    Madrid, Spain
    Recruiting
08

References and documents

Publications

  • ACOG Practice Bulletin No. 106: Intrapartum fetal heart rate monitoring: nomenclature, interpretation, and general management principles. Obstet Gynecol. 2009 Jul;114(1):192-202. doi: 10.1097/AOG.0b013e3181aef106. No abstract available. PubMed 19546798 ↗
  • Murphy DJ, Shahabuddin Y, Yambasu S, O'Donoghue K, Devane D, Cotter A, Gaffney G, Burke LA, Molloy EJ, Boland F. Digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS) to assess fetal wellbeing in labour-a multi-centre randomised controlled trial: Fetal Intrapartum Randomised Scalp Stimulation Trial (FIRSST NCT05306756). Trials. 2022 Oct 4;23(1):848. doi: 10.1186/s13063-022-06794-9. PubMed 36195894 ↗
  • Shakouri F, Iorizzo L, Edwards HMK, Vinter CA, Kristensen K, Isberg PE, Wiberg N. Effectiveness of fetal scalp stimulation test in assessing fetal wellbeing during labor, a retrospective cohort study. BMC Pregnancy Childbirth. 2020 Jun 5;20(1):347. doi: 10.1186/s12884-020-03030-7. PubMed 32503518 ↗
  • Tahmina S, Daniel M, Krishnan L. Manual fetal stimulation during intrapartum fetal surveillance: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100574. doi: 10.1016/j.ajogmf.2022.100574. Epub 2022 Jan 17. PubMed 35051669 ↗
  • Al Wattar BH, Lakhiani A, Sacco A, Siddharth A, Bain A, Calvia A, Kamran A, Tiong B, Warwick B, MacMahon C, Marcus D, Long E, Coyle G, Lever GE, Michel G, Gopal G, Baig H, Price HL, Badri H, Stevenson H, Hoyte H, Malik H, Edwards J, Hartley J, Hemers J, Tamblyn J, Dalton JAW, Frost J, Subba K, Baxter K, Sivakumar K, Murphy K, Papadakis K, Bladon LR, Kasaven L, Manning L, Prior M, Ghosh M, Couch M, Altunel M, Pearce M, Cocker M, Stephanou M, Jie M, Mistry M, Wahby MO, Saidi NS, Ramshaw NL, Tempest N, Parker N, Tan PL, Johnson RL, Harris R, Tildesley R, Ram R, Painuly R, Cuffolo R, Bugeja R, Ngadze R, Grainger R, Gurung S, Mak S, Farrell S, Cowey S, Neary S, Quinn S, Nijjar SK, Kenyon S, Lamb S, Tracey S, Lee T, Kinsella T, Davidson T, Corr T, Sampson U, McQueen V, Smith WP, Castling Z; AB-FAB study group. Evaluating the value of intrapartum fetal scalp blood sampling to predict adverse neonatal outcomes: A UK multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:62-67. doi: 10.1016/j.ejogrb.2019.06.012. Epub 2019 Jun 15. PubMed 31229725 ↗
  • Carbonne B, Pons K, Maisonneuve E. Foetal scalp blood sampling during labour for pH and lactate measurements. Best Pract Res Clin Obstet Gynaecol. 2016 Jan;30:62-7. doi: 10.1016/j.bpobgyn.2015.05.006. Epub 2015 Jul 8. PubMed 26253238 ↗
  • Chandraharan E, Wiberg N. Fetal scalp blood sampling during labor: an appraisal of the physiological basis and scientific evidence. Acta Obstet Gynecol Scand. 2014 Jun;93(6):544-7. doi: 10.1111/aogs.12416. PubMed 24806702 ↗
  • Chandraharan E. Should national guidelines continue to recommend fetal scalp blood sampling during labor? J Matern Fetal Neonatal Med. 2016 Nov;29(22):3682-5. doi: 10.3109/14767058.2016.1140740. Epub 2016 Feb 24. PubMed 26762827 ↗
  • Tahir Mahmood U, O'Gorman C, Marchocki Z, O'Brien Y, Murphy DJ. Fetal scalp stimulation (FSS) versus fetal blood sampling (FBS) for women with abnormal fetal heart rate monitoring in labor: a prospective cohort study. J Matern Fetal Neonatal Med. 2018 Jul;31(13):1742-1747. doi: 10.1080/14767058.2017.1326900. Epub 2017 May 19. PubMed 28475393 ↗
  • Hughes O, Murphy DJ. Comparing second-line tests to assess fetal wellbeing in Labor: a feasibility study and pilot randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Jan;35(1):91-99. doi: 10.1080/14767058.2020.1712704. Epub 2020 Jan 12. PubMed 31928269 ↗
  • East CE, Leader LR, Sheehan P, Henshall NE, Colditz PB, Lau R. Intrapartum fetal scalp lactate sampling for fetal assessment in the presence of a non-reassuring fetal heart rate trace. Cochrane Database Syst Rev. 2015 May 1;2015(5):CD006174. doi: 10.1002/14651858.CD006174.pub3. PubMed 25929461 ↗
  • Troha N, Razem K, Luzovec U, Lucovnik M. Comparison of Four Intrapartum Cardiotocography Classifications for Predicting Neonatal Acidemia at Birth. J Pregnancy. 2023 Feb 13;2023:5853889. doi: 10.1155/2023/5853889. eCollection 2023. PubMed 36814692 ↗
  • Alfirevic Z, Devane D, Gyte GM, Cuthbert A. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD006066. doi: 10.1002/14651858.CD006066.pub3. PubMed 28157275 ↗
  • Murphy DJ, Devane D, Molloy E, Shahabuddin Y. Fetal scalp stimulation for assessing fetal well-being during labour. Cochrane Database Syst Rev. 2023 Jan 10;1(1):CD013808. doi: 10.1002/14651858.CD013808.pub2. PubMed 36625680 ↗
  • Jia YJ, Chen X, Cui HY, Whelehan V, Archer A, Chandraharan E. Physiological CTG interpretation: the significance of baseline fetal heart rate changes after the onset of decelerations and associated perinatal outcomes. J Matern Fetal Neonatal Med. 2021 Jul;34(14):2349-2354. doi: 10.1080/14767058.2019.1666819. Epub 2019 Sep 18. PubMed 31533502 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07035028
Lead sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
CEU San Pablo University, Hospital Universitario Sanitas La Zarzuela
Responsible party
Raquel Maqueda Moreno (Investigator name, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz) — Principal investigator
First posted
Jun 24, 2025
Start date
Jan 1, 2024
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 24, 2025

Study contacts

RAQUEL MAQUEDA, MATRONA
Contact
raquel.maquedamoreno@usp.ceu.es
+34 915504800 ext. 2561
JAVIER PLAZA ARRANZ, Doctor
study director · Hospital Fundación Jiménez Diaz

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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