RecruitingNAINTERVENTIONAL

Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

This study aims to understand how common medicines, given to raise blood pressure during a C-section, affect the womb's ability to contract. This is especially important for pregnant people with Type 2 or gestational diabetes, as they have a higher risk of heavy bleeding after birth (postpartum hemorrhage). During a C-section, a type of pain relief called a 'spinal' can cause blood pressure to drop. Doctors then give medicines like ephedrine to bring it back up. We're investigating if these blood pressure medicines affect the womb muscle, which needs to contract well after birth to stop bleeding. By studying small womb tissue samples in the lab, we hope to find safer ways to manage blood pressure during C-sections for diabetic patients.

At a glance

Status

Recruiting

Phase

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Enrolment target

Start

18 Mar 2024

Estimated completion

01 Dec 2026

Postpartum Hemorrhage

What is this study about?

When you have a C-section, especially with a spinal anaesthetic for pain relief, your blood pressure can sometimes drop too low. To quickly fix this, doctors might give you medicines called 'vasopressors' which help raise your blood pressure. However, these medicines can also affect other muscles in your body, including the womb.

After your baby is born, it's really important for your womb to contract strongly. This helps to squeeze off the blood vessels that were connected to the placenta, preventing heavy bleeding, known as postpartum hemorrhage (PPH). We know that people with Type 2 or gestational diabetes have a higher chance of experiencing this heavy bleeding.

This study wants to find out if the medicines given to raise blood pressure during a C-section affect how well the womb contracts, particularly in pregnant people with diabetes. We'll also look at how medicines commonly given to help the womb contract after delivery might work alongside the blood pressure medicines. Understanding this could help doctors make safer choices for diabetic mothers having C-sections, reducing their risk of PPH.

Key takeaways

This study investigates how blood pressure medicines given during C-sections affect the womb.
It focuses on pregnant people with Type 2 or gestational diabetes due to their higher risk of heavy bleeding.
Tiny womb tissue samples are taken during your C-section for lab research.
Participation involves no extra procedures, medications, or hospital visits.
The goal is to improve safety and care for diabetic mothers having C-sections.

Who may be eligible?

To join this study, you need to be openly willing to participate. You should be between 19 and 45 years old and about to have an elective (planned) C-section under spinal anaesthesia, either for the first time or as your first repeat C-section. Your pregnancy should be between 37 and 41 weeks along.

We are looking for people who have been diagnosed with either Type 2 diabetes or gestational diabetes. We also need a comparison group of healthy pregnant people who don't have diabetes. For this healthy group, your BMI (a measure of weight compared to height) should be normal, and your baby's weight should be average.

You cannot join if you are already in labour, need an emergency C-section, or have had previous major womb surgeries. Also, if you have certain conditions that significantly increase your risk of heavy bleeding, you might not be able to participate, though if you have diabetes, some common related conditions like being overweight or having a larger baby won't stop you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 19 and 45 years old?
Are you having a planned C-section under spinal anaesthesia?
Have you been diagnosed with Type 2 or gestational diabetes (or are you a healthy control with normal BMI and average baby weight)?
Are you 37-41 weeks pregnant?
Are you not in labour and not having an emergency C-section?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the main thing involved is providing a tiny sample of your womb muscle. This sample is taken from the edge of the cut made during your C-section, so it won't involve any extra cuts. This happens after your baby is delivered and won't affect your recovery or health. There are no extra visits or medications involved due to the study; you will still receive your routine care. The duration of your participation is essentially limited to the time of your C-section and the collection of this tissue sample, as all further tests are done in a lab.

Potential risks and benefits

The main benefit of taking part is helping us learn more about how medicines affect womb contractions, which could improve care for diabetic mothers having C-sections in the future. The risks of this study are very low, as the womb tissue sample is tiny and taken from tissue that would normally be discarded. There are no additional procedures or medications given specifically for the study. Remember, you can decide to withdraw from the study at any time, for any reason, and this will not affect your medical care.

Locations (1)

Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is postpartum hemorrhage?

Postpartum hemorrhage (PPH) is when a woman experiences very heavy bleeding after giving birth. It's a serious condition that doctors try to prevent and treat quickly.

What is a 'spinal' anaesthetic?

A 'spinal' is a type of pain relief given during a C-section that numbs the lower half of your body, so you don't feel pain during the operation but remain awake.

Why is this study important for people with diabetes?

People with diabetes have a higher risk of heavy bleeding after a C-section. This study helps us understand if common blood pressure medicines affect their womb's ability to stop bleeding, potentially making C-sections safer.

Will taking part affect my C-section or recovery?

No, taking part will not change your C-section procedure, how you recover, or the care you receive. The tissue sample is taken during your surgery, from an area that is already being cut.

Do I have to take any extra medication for this study?

No, you will not be asked to take any additional medication specifically for this study. All medications you receive will be part of your standard medical care during your C-section.

How to find out more

Mrinalini Balki, MD

mrinalini.balki@uhn.ca 416-586-4800 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.