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New drug combo may ease Post-Epidural headaches in new moms

NCT ID NCT05116930

Symptom relief Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether two drugs, neostigmine and glycopyrrolate, can treat severe headaches that sometimes occur after an epidural needle accidentally punctures the spinal lining during labor. The study will enroll 18 postpartum women with this type of headache. The goal is to see if the drugs reduce the need for a standard treatment called an epidural blood patch.

What this could mean

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

Active substance
Neostigmine and glycopyrrolate (drugs given through an IV)
What this could lead to
If it works, this could offer a new, less invasive way to treat severe headaches after epidural placement in labor, potentially avoiding a more invasive procedure.
What could go wrong
This is a very small pilot study with only 18 participants, so results may not apply widely. The drugs can cause side effects like nausea or heart rhythm changes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

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 to 54 years

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: * Post-dural puncture headache (PDPH) after documented dural puncture with Tuohy needle during placement of epidural analgesia for labor and no other explanation for headache (HA). * Onset of HA within 72 hours of delivery. Exclusion Criteria: * Patient refusal. * Visual analog scale (NRS) score \< 4. * History of migraine headaches. * Asthma. * Arrhythmia. * Heart block. * Myasthenia gravis. * Inability to understand pain scores and other questionnaires. * Inability to speak English. * Contraindication to acetaminophen or NSAIDs. * Temperature \> 38.5 C. * Prior EBP done for this HA.

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Conditions

The condition(s) this trial relates to.

intracranial hypotension Post-Dural Puncture Headache

As listed by the trial registrant

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

Post-dural puncture headache

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

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