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New combo drug may offer safer labor pain relief

NCT ID NCT07264309

Symptom relief Sponsor: Zohar Nachum 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a combination of two medicines given through an IV (tramadol and paracetamol) works better and causes fewer side effects than a standard shot of pethidine for managing pain during the first stage of labor. About 140 women in early labor will be randomly assigned to one of the two treatments. The main goal is to see which approach provides better pain relief one hour after the medicine is given.

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 140 people

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

Started

Nov 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor - Exclusion Criteria: * Previous cesarean delivery * Malpresentation * Multiple pregnancies * Suspected intrauterine growth restriction \< 3 percentile * Suspected placental abruption * History of allergy to paracetamol, tramadol or pethidine * Women with sleep apnea disorder * Morbid obesity BMI≥40 * History of significant cardiac, liver and renal diseases * Anti-convulsive medication consumption * MAO inhibitors medication consumption within the last 14 days * Non reassuring fetal heart rate monitoring (type II or III) * Tense use

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Conditions

The condition(s) this trial relates to.

agnosia

As listed by the trial registrant

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

BIRTH Pain management

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

  • HaEmek MC

    RECRUITING

    Afula, Israel

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