Twin Pregnancy With Antenatal ProblemNCT05894785
External Cephalic Version (ECV) for Twins With Non-vertex Presenting Twin
A study testing External cephalic version in people with Twin Pregnancy With Antenatal Problem, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Twin Pregnancy With Antenatal Problem
- What is being tested?
- External cephalic version
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Feb 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older multiparous no previous cesarean delivery (CD) a non-vertex presenting twin in a term (37 weeks gestation and onwards) dichorionic diamniotic twin pregnancy
Who cannot join
- contraindication for a vaginal delivery nulliparous monochorionic diamniotic pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Zvi Ehrlich, MD
Zvi Ehrlich, MD
About this study
In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version.
- Conditions
- Twin Pregnancy With Antenatal Problem
- Being tested
- External cephalic version
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External cephalic versionProcedure or surgery
An ECV attempt is made on the study group
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Procedure: External cephalic version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rates of ECV
Measured: 1 day
Secondary outcomes (1)
Maternal and fetal morbidities
Measured: up to 7 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start27 Feb 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zvi Ehrlich, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894785
- Sponsor's protocol ID
- 0327-21-SZMC
- Status last verified
- Apr 2024
- First submitted
- 29 May 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Cephalic Version (ECV) for Twins With Non-vertex Presenting Twin
- ClinicalTrials.gov ID
- NCT05894785
- Acronym / sponsor ID
- 0327-21-SZMC
- Conditions
- Twin Pregnancy With Antenatal Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: External cephalic version |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old or older multiparous no previous cesarean delivery (CD) a non-vertex presenting twin in a term (37 weeks gestation and onwards) dichorionic diamniotic twin pregnancy
Key exclusion criteria (1 listed)
- contraindication for a vaginal delivery nulliparous monochorionic diamniotic pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External cephalic versionAn ECV attempt is made on the study group | Procedure or surgery | Study group |
Primary outcome
Success rates of ECV
Time frame: 1 day
1 secondary outcome
Maternal and fetal morbidities
Time frame: up to 7 days from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Twin Pregnancy With Antenatal Problem
Active, not recruitingObservational study
Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
RecruitingObservational study
Twin Pregnancy: a Challenge for Patients, Families and Health Professionals
Twin Pregnancy With Antenatal Problem, Twin Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External cephalic version in people with Twin Pregnancy With Antenatal Problem, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Ehrlich (+9726555562, ehrlichz@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rates of ECV (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.