RecruitingNAINTERVENTIONAL

Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study

This study aims to understand how different medicines, used to treat low blood pressure during C-sections, affect the womb and baby's umbilical cord. When women have spinal anaesthesia for a C-section, their blood pressure can drop. Doctors give medicines like ephedrine, phenylephrine, norepinephrine, or vasopressin to help. However, some of these medicines might affect the baby's oxygen levels. This research will use lab tests on small tissue samples to see how these medicines directly impact the womb's contractions and the vessels in the umbilical cord. The goal is to find out which medicine is safest and most effective for both mother and baby, helping doctors make better choices.

At a glance

Status

Recruiting

Phase

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Enrolment target

144

Start

08 Jul 2019

Estimated completion

01 Dec 2026

Hypotension

What is this study about?

When women have a C-section with spinal anaesthesia, their blood pressure can sometimes drop too low. This is quite common and can affect both the mother and baby. To prevent or treat this, doctors use various medicines that help raise blood pressure. For a long time, ephedrine was used, but then studies suggested that phenylephrine might be better for the baby's oxygen levels. More recently, norepinephrine has also been introduced because it might help the mother's heart better.

There's still a lot of discussion about which medicine is best. Doctors want to make sure the medicine that treats the mother's low blood pressure doesn't harm the baby. Specifically, they're concerned about whether these medicines might reduce blood flow to the baby or cause the umbilical cord vessels to tighten, potentially affecting the baby's oxygen supply. This study will examine how these different medicines affect human womb tissue and umbilical cord vessels in a laboratory setting.

By carefully studying these effects outside of the body, researchers can get a clear picture of how each medicine works. This will help them understand why some medicines might impact the baby's oxygen levels more than others. The ultimate goal is to provide doctors with better information to choose the safest and most effective medicine for mums undergoing C-sections, ensuring the best possible outcome for both mother and baby.

Key takeaways

This study investigates how different blood pressure medicines affect the womb and umbilical cord.
It aims to find the safest medicine for mothers and babies during C-sections when blood pressure drops.
Researchers will study tissue samples in a lab, not directly involve you after your operation.
Your participation involves donating small pieces of womb and umbilical cord tissue during your C-section.
There are no additional physical risks or follow-up for you beyond your normal medical care.
The findings could help doctors make better choices about C-section medicines in the future.

Who may be eligible?

This study is looking for women who are between 19 and 40 years old and are 37 to 41 weeks pregnant. You might be able to take part if you are having an elective C-section, meaning it's planned rather than an emergency, and you'll be having spinal anaesthesia (a जग) rather than general anaesthesia.

However, you won't be able to join if you're already in labour or taking medicines to start labour. You also can't participate if you've had previous surgery on your womb, had more than one C-section before, or have certain health conditions that might affect your womb or if you're taking specific medications that could interfere with the study, like insulin or blood pressure medicines such as nifedipine or labetalol.

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 40 years old?
Are you 37-41 weeks pregnant?
Are you having a planned C-section?
Will you receive spinal anaesthesia for your C-section?
Have you not had more than one previous C-section?
Are you not in labour or taking medicines to start labour?

Answer every question to see your result.

What does participation involve?

This study is an 'in-vitro' study, which means it will be carried out in a laboratory using small tissue samples, not directly involving you after your C-section. If you meet the eligibility criteria and agree to take part, you will give written consent. During your planned C-section, small pieces of your womb tissue and umbilical cord will be collected, which would normally be discarded. There will be no extra visits, assessments, or medications for you as part of this study beyond your standard care. The study focuses purely on lab tests of these tissues to understand how different blood pressure medicines affect them. You will not receive any follow-up related to the study itself once your tissue samples have been collected. There is no total duration of participation for you, as it's a one-time tissue donation.

Potential risks and benefits

There are no direct benefits to you for taking part in this study, as the research is conducted in a lab using tissue that would otherwise be discarded. However, your contribution could help doctors better understand which blood pressure medicines are safest for mothers and babies during C-sections in the future. As the study only involves taking tissue samples that are normally thrown away during your C-section, there are no additional physical risks to you. You have the right to withdraw your consent at any time before your tissue samples are collected and used for the study, without affecting your medical care.

Locations (1)

Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a C-section?

A C-section, or Caesarean section, is a surgical procedure where a baby is delivered through a cut in the mother's tummy and womb.

What is spinal anaesthesia?

Spinal anaesthesia is like a very strong injection in your back that numbs the lower part of your body so you don't feel pain during surgery, but you remain awake.

What is hypotension?

Hypotension means 'low blood pressure.' It can happen during C-sections with spinal anaesthesia and needs to be treated to keep mum and baby well.

What are vasopressors?

Vasopressors are medicines given to help raise your blood pressure if it drops too low. They work by tightening blood vessels.

Will I get any specific treatment as part of this study?

No, this study only involves collecting tissue samples during your C-section that would normally be discarded. You won't receive any specific treatment or medication directly for the study.

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.