ClinicalTrials.gg
Not yet recruitingNCT07924033PERIFROIDUpdated Nov 9, 2026

Predicting Perineal Pain During the Expulsive Phase Under Obstetric Epidural Analgesia

An observational study in Epidural Anesthesia in Labor and Delivery, Pain During Delivery and Perineal Pain, sponsored by University Hospital, Toulouse. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University Hospital, Toulouse · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
340
Ages
18 Years and older
Sex
Female
01

Study summary

Insufficient perineal coverage can cause pain as the baby's head emerges, a condition that affects 30% of patients. Currently, there is no consensus on which cold-test site is most predictive of this pain.

Detecting a block that does not extend to the sacral roots is crucial for anticipating the pain experienced during the emergence of the baby's head. Identifying the most predictive testing site would allow the anesthesiologist to anticipate this pain and adjust analgesic management accordingly.

Read the detailed description

Epidural analgesia (ED) is the gold standard for pain relief during labor. An accurate assessment of its sensory and motor coverage is essential to ensure both effective pain relief and patient safety. Insufficient perineal coverage can cause pain as the baby's head emerges, a condition that affects 30% of patients. Currently, there is no consensus on which cold-test site is most predictive of this pain. Several dermatomal areas can be assessed at the patient's bedside: the outer edge of the foot (S1 root), the posterior aspect of the thigh (S1-S2 roots), and the perianal region (S3-S4-S5 roots). A direct comparison of these three sites, tested on the same patient upon admission for delivery, has not been established.

Detecting a block that does not extend to the sacral roots is crucial for anticipating the pain experienced during the emergence of the baby's head. Identifying the most predictive testing site would allow the anesthesiologist to anticipate this pain and adjust analgesic management accordingly.

02

Conditions studied

  • Epidural Anesthesia in Labor and Delivery
  • Pain During Delivery
  • Perineal Pain

Browse trials for

Keywords

  • Epidural Anesthesia in Labor and Delivery
  • perineal pain
  • block detection
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 340 is above the median of 100 across 1,252 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant patients from University Hospital of Toulouse

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

  • Female patients aged ≥ 18 years
  • Singleton pregnancy ≥ 37 weeks of amenorrhea
  • Indication for epidural analgesia during spontaneous labor
  • Cephalic presentation
  • Proficiency in French

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • to epidural analgesia
  • Pre-existing neurological condition
  • Infection at the puncture site
  • Uncorrected coagulation disorder
  • Obstetric emergency requiring immediate delivery
  • Guardianship, conservatorship, or court-ordered protection
Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
340 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pregnant woman with Indication for epidural analgia

    Pregnant woman, Singleton pregnancy ≥ 37 weeks of amenorrhea, Indications for epidural analgesia during spontaneous labor, Cephalic presentation

06

What researchers measure

Primary outcomes

  1. diagnostic performance comparison of three sites for testing sensitivity to cold

    Composite criterium: diagnostic performance (sensitivity, specificity, positive and negative predictive values, area under the ROC curve) comparison of three sites for testing sensitivity to cold-the outer edge of the foot, the posterior thigh, and the perianal region-to predict the onset of pain upon the emergence of the fetal head, defined as an intensity of ≥ 4/10 on the numerical scale (NS), in parturients under epidural analgesia.

    Time frame: Day 0 (emergence of the fetal head)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.

Of 504 non-industry observational studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 6 months is below that.

Counting every sponsor, half of 519 studies reached it within 18 months; a quarter within 8 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 9, 2026
StartEst.
Nov 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924033
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Kaissar SASSI, MD-PH
Contact
sassi.k@chu-toulouse.fr
+33 5 61 77 22 33
KAISSAR SASSI, MD-PH
principal investigator · UHT

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion