RecruitingOBSERVATIONAL

Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

This study, called TWEXIT, is exploring a procedure known as External Cephalic Version (ECV) for women carrying twins. Specifically, it focuses on cases where the first twin (Twin A) is positioned bottom-down, rather than head-down. ECV is a gentle method doctors can use to try and turn a baby from a breech position to a head-down position from the outside of the mother's tummy. The main goal of this research is to find out how successful this procedure is for Twin A in our clinic. We also want to identify any new clues we can see on ultrasound scans that might tell us if ECV is more likely to work, which could help doctors decide if and when to attempt it.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

28 Sep 2020

Estimated completion

28 Sep 2026

Breech Presentation Twin; Complicating Pregnancy

What is this study about?

This research study, called TWEXIT, is looking into a situation that can happen during twin pregnancies. Sometimes, one or both babies might be in a 'breech' position, meaning they are positioned bottom-down or feet-down instead of head-down. This study specifically focuses on the first twin (Twin A) when they are in a breech position.

The study is investigating a procedure called External Cephalic Version, or ECV for short. ECV is where a doctor gently tries to turn the baby from the outside of your tummy, to help them move into a head-down position. This is often done to make a vaginal birth more likely.

The main aim of the TWEXIT study is to find out how often ECV successfully turns Twin A in our hospital. We also want to learn if there are any specific signs we can see on an ultrasound scan that tell us if ECV is more likely to work. Understanding these signs could help doctors make better decisions about when to offer this procedure, potentially improving outcomes for mothers and babies.

Key takeaways

The study looks at turning the first twin (Twin A) when they are breech.
It uses a method called External Cephalic Version (ECV).
The goal is to see how well ECV works and find clues on ultrasound for success.
You must be 18 or over and give written consent to join.
Taking part means your routine medical information for ECV will be used for research.
You can withdraw at any time without affecting your care.

Who may be eligible?

To join this study, women must be at least 18 years old and be able to understand and agree to take part. Your doctor will explain everything clearly, and you will need to give your written permission.

There are certain reasons why you wouldn't be able to join. For instance, if you are under 18 or can't give your clear consent. Also, if you have a condition called placenta previa (where the placenta is covering the cervix), or if there are any known health problems with the babies, you wouldn't be able to participate. These checks are important to make sure the study is safe for everyone involved.

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 18 years old or older?
Do you understand what the study is about and are you willing to give your written consent?
Do you have a twin pregnancy where Twin A is in a breech (bottom-down) position?
Have your doctors confirmed you do not have placenta previa?
Have your doctors confirmed there are no known health problems with your babies?

Answer every question to see your result.

What does participation involve?

The study aims to understand what happens to women who are already undergoing an External Cephalic Version (ECV) for their twin pregnancy. If you decide to take part, the main things involved will be the ECV procedure itself, which your doctor would discuss with you regardless of the study. Beyond that, the researchers will be looking at information gathered during your regular antenatal appointments, such as your ultrasound scan results before and after the ECV. There wouldn't be any extra study visits, medications, or prolonged follow-up specifically for this research, beyond what is already part of your usual pregnancy care. The researchers are essentially observing and collecting data from standard medical procedures.

Potential risks and benefits

Participating in this study means that medical staff will be carefully observing and recording the details of your ECV procedure and its outcome. This information will help improve care for other women with twin pregnancies in the future. As the ECV procedure is something your doctor might already recommend, taking part in the study itself is thought to have very few additional risks beyond the usual risks of an ECV, which your doctor will discuss with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Charité University Hospital
Verified postcode
Mitte, Germany· Recruiting

Common questions

What is 'breech presentation'?

Breech presentation means your baby is positioned bottom-down or feet-down in your womb, instead of head-down.

What is External Cephalic Version (ECV)?

ECV is a gentle procedure where doctors try to turn the baby from a breech position to a head-down position by pressing on your tummy from the outside.

Who is Twin A?

Twin A is the twin closest to your cervix, usually the first baby to be born.

Will I have extra appointments if I join?

No, this study mainly collects information from your routine pregnancy appointments and the ECV procedure you would already be having.

Can I change my mind about taking part?

Yes, you can decide to stop participating at any time, and it won't affect your medical care.

How to find out more

Larry Hinkson, FRCOG

larry.hinkson@charite.de 004930450664710 Official trial record

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