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Search / Trial NCT06847308

Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 20, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

2nd Stage Of Labour Visual Biofeedback Maternal Childbirth Satisfaction Obstetrics Ultrasound Trans Perineal Ultrasound

ClinConnect Summary

This clinical trial is exploring a new method to help improve women's satisfaction during childbirth. It focuses on using a technique called Visual Biofeedback through Trans-Perineal Ultrasound during the second stage of labor. The goal is to help mothers feel more in control and empowered during their delivery, which may lead to a more positive birth experience. The researchers believe that by improving communication between the mother and her healthcare team, the overall satisfaction with childbirth can be enhanced.

To participate in this trial, women must meet certain criteria. Eligible participants are those who are pregnant with a single baby, at least 37 weeks along, and planning to have a vaginal birth. They should also be receiving epidural pain relief during labor. However, women with certain health issues or significant psychiatric concerns, as well as those who cannot understand or give consent in Dutch, will not be included. If you join the study, you can expect to receive the Visual Biofeedback during labor, which may help you feel more connected and informed throughout the process.

Gender

FEMALE

Eligibility criteria

  • INCLUSION criteria (all must be met):
  • 1. Voluntary written informed consent of the participant.
  • 2. Term (37-42w) singleton gestations.
  • 3. Vaginally nulliparous (no previous vaginal birth \> 20 weeks of gestation).
  • 4. Fetus in cephalic presentation, without any major congenital or chromosomal anomalies.
  • 5. Admitted to the delivery unit in labour, regardless of the onset (spontaneous or induced).
  • 6. Epidural analgesia in situ.
  • 7. Non-pathological CTG at the time of recruitment (2015 FIGO classification).
  • EXCLUSION criteria (if one or more is present):
  • Significant psychiatric comorbidity (psychiatric follow-up during pregnancy, or active (psycho-pharmacological) treatment).
  • History of severe PFDs/surgery (or any other condition affecting pelvic floor function/anatomy, besides pregnancy and delivery).
  • Significant neurological disease e.g., spinal injury, multiple sclerosis, diabetic neuropathy, etc.
  • Significant connective tissue disorders (e.g., Ehlers-Danlos syndrome).
  • Severe active maternal (pregnancy-related) comorbidity: non-exhaustive e.g., severe hypertensive disorder, significant antepartum haemorrhage, sepsis, thromboembolism, severe pre-existing cardiac/respiratory/neurological disease, etc. Well-controlled comorbidities will not be considered exclusion criteria (non-exhaustive e.g., well-controlled (gestational) diabetes, hypertensive disorders of pregnancy, PROM without signs of intra-amniotic infection, etc.).
  • Linguistic barriers - not able to give written informed consent in Dutch.
  • Severe visual impairment (sufficient to the receipt/comprehension of visual biofeedback).

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Braband, Belgium

Patients applied

0 patients applied

Trial Officials

Jute Richter, MD, PhD

Principal Investigator

University Hospitals Leuven / KU Leuven

Jan Deprest, MD, PhD

Principal Investigator

University Hospitals Leuven / KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported