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Bicarbonate drink could reduce emergency C-Sections in prolonged labour

NCT ID NCT07321379

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether a single dose of oral bicarbonate can reduce the need for assisted delivery (emergency C-section or vacuum/forceps) in first-time mothers with prolonged labour. 1520 women will be randomly assigned to receive bicarbonate or a placebo. After two hours, if labour hasn't progressed, standard oxytocin treatment is given. The study also tracks birth experience and newborn health.

What this could mean

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

Active substance
sodium bicarbonate
What this could lead to
If it works, this could offer a simple, low-cost way to reduce emergency C-sections and vacuum/forceps deliveries in prolonged labour.
What could go wrong
This is an early-stage trial with no prior human data for this use. The effect may be small or none, and results may not apply to all women.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,520 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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 50 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: * Age ≥18 years. * Danish or English speaking. * Cephalic presentation. * Gestational age ≥34+0 - \<42+0 (days +weeks) at onset of labour. * Normal foetal heart rate pattern in the 20 minutes prior to inclusion. * Spontaneous onset of labour or non-medical induced labour (balloon catheter and/or artificial rupture of membranes). * Active first stage of labour confirmed, according to Danish national guidelines: Cervical dilatation at ≥4 - \<10 cm with regular painful contractions. * Prolonged labour diagnosed, according to Danish national guidelines: Cervical dilatation progresses at less than 2 cm over a 4-hour period. Exclusion Criteria: * Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated) * Significant medical comorbidity in the form of renal or heart condition, assessed case-by-case basis. * Serious obstetric complication * Known allergy or intolerance to sodium bicarbonate. * Ingestion of sodium bicarbonate in active labour prior to inclusion. * Current treatment with following medicines: Gabpabpentin, Tetracycline, Ketoconazole (NB! These medications are already generally advised contradicted against induring pregnancy)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Copenhagen University Hospital, Hvidovre

    Copenhagen, Denmark

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen, Denmark

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