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Faster recovery after cervical stitch: Shorter-Acting spinal anesthetic tested

NCT ID NCT04394533

Symptom relief Sponsor: Guy's and St Thomas' NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether a shorter-acting spinal anesthetic (prilocaine) helps pregnant women recover feeling and movement faster after a cervical stitch procedure compared to the standard drug (bupivacaine). About 129 healthy pregnant women at risk of preterm loss will receive one of the two drugs via spinal injection. The goal is to see if prilocaine allows quicker return of leg strength and sensation, enabling earlier hospital discharge and less need for a urinary catheter.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prilocaine (hyperbaric 2%) and Bupivacaine (hyperbaric 0.5%)
What this could lead to
If prilocaine works better, women could recover feeling and movement faster after a cervical stitch, leaving the hospital sooner and avoiding a urinary catheter.
What could go wrong
This is a small, single-center trial. The benefit may be modest, and prilocaine might not provide enough numbness for the procedure in some cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

129 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB. * Age \> 18 years Exclusion Criteria: * Inability to read or understand the patient information sheet (PIS) * Age \< 18 years * Unable or unwilling to consent to participation * non-elective procedure * serious co-morbidities (ASA score 4 or above) * any contraindication to SAB, e.g. local or generalised infection, active central nervous system disease, coagulation disorders or anti-coagulant medication * any history of allergic reaction to any of the medications in the protocol * concomitant use of class III anti-arrhythmics (sulfonamides, antimalarials, sodium nitroprussate, nitroglycerin, other local anaesthetics) * any contraindication to the use of bupivacaine or prilocaine as listed in the SmPCs.

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Conditions

The condition(s) this trial relates to.

cervical incompetence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical incompetence in pregnancy as antepartum condition

Contacts and locations

Locations

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7RT, United Kingdom