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C-Section drug study targets bleeding risk in diabetic moms

NCT ID NCT06285396

Knowledge-focused Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how three common blood pressure medications (ephedrine, phenylepinephrine, and norepinephrine) affect the ability of the uterus to contract after a C-section in women with type 2 or gestational diabetes. Researchers will take small tissue samples from the uterus during surgery and test the drugs in the lab. The goal is to understand why diabetic women have a higher risk of severe bleeding after delivery and how to choose safer medications.

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 96 people

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

Started

Mar 2024

Expected to finish

Dec 2026

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

19 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients who have given consent to participate in the study * Patients with gestational age 37-41 weeks * Patients previously diagnosed with either Type II or Gestational diabetes. For the healthy control group, no previous diagnosis is required for inclusion * Patients of 19-45 years * Patients of normal BMI (18-30 BMI) for the healthy control group only * Baby is registered as normal weight for size for the healthy control group only * Non-laboring patients, not exposed to exogenous oxytocin * Patients requiring elective primary or first repeat caesarean delivery * Patients undergoing caesarean delivery under spinal anesthesia Exclusion Criteria: * Patients who refuse to give written informed consent * Patients who require general anesthesia * Patients in labor and those receiving oxytocin for induction of labor * Emergency caesarean delivery in labor * Patients who have had previous uterine surgery involving myometrial dissection or \>1 previous caesarean delivery * Patients with risk factors for PPH such as those with polyhydramnios, preeclampsia, multiple gestation, morbid obesity, macrosomia (large for size baby), and previous history of PPH. However, for diabetic group, those with morbid obesity and macrosomia will not be excluded as these conditions are almost always associated with diabetes. * For the healthy control group only, a BMI \>30 or \<18 * Maternal age \>45

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Conditions

The condition(s) this trial relates to.

gestational diabetes Postpartum Hemorrhage type 2 diabetes mellitus

As listed by the trial registrant

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

Postpartum hemorrhage

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

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, M5G1X5, Canada

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