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

NCT07035028 | Recruiting DMC

• 1 other identifier: PIC005-24_FJD
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

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.

Conditions

Fetal Hypoxia; Fetal Monitoring

Keywords

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

Outcome Measures

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.

  2 years

Secondary Outcomes (36)

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

  2 years

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

  2 years

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

  2 years

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

  2 years

• 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

  2 years

Study Arms (2)

digital fetal scalp stimulation dFSS

EXPERIMENTAL

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 digital fetal scalp stimulation dFSS

NO INTERVENTION

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

Digital fetal scalp stimulation dFSS DIAGNOSTIC_TEST

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

digital fetal scalp stimulation dFSS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years of age.
• Contraindication for FBS
• Uterine dilatation that does not make FBS possible.
• HIV
• Hepatitis
• Fetuses at increased risk of hemorrhage.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• CEU San Pablo University: collaborator
• Hospital Universitario Sanitas La Zarzuela: collaborator

Study Sites (2)

Fundación Jimenez Diaz Y Hospital La Zarzuela

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Sanitas La Zarzuela

Madrid, Spain

RECRUITING

Related Publications (15)

• 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.

  PMID: 19546798 BACKGROUND

• 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.

  PMID: 36195894 BACKGROUND

• 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.

  PMID: 32503518 BACKGROUND

• 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.

  PMID: 35051669 BACKGROUND

• 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.

  PMID: 31229725 BACKGROUND

• 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.

  PMID: 26253238 BACKGROUND

• 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.

  PMID: 24806702 BACKGROUND

• 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.

  PMID: 26762827 BACKGROUND

• 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.

  PMID: 28475393 BACKGROUND

• 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.

  PMID: 31928269 BACKGROUND

• 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.

  PMID: 25929461 BACKGROUND

• 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.

  PMID: 36814692 BACKGROUND

• 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.

  PMID: 28157275 BACKGROUND

• 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.

  PMID: 36625680 BACKGROUND

• 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.

  PMID: 31533502 BACKGROUND

Related Links

• Fetal monitoring in labour
• SEGO DOCUMENTOS DE CONSENSO 2007.

MeSH Terms

Conditions

Fetal Hypoxia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JAVIER PLAZA ARRANZ, Doctor

  Hospital Fundación Jiménez Diaz

  STUDY DIRECTOR

Central Study Contacts

RAQUEL MAQUEDA, MATRONA

CONTACT

+34 915504800; raquel.maquedamoreno@usp.ceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator name

Model Details: Control group Experimental group

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 24, 2025
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)