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Procedure

Cerclage for Short Cervix in Twin Pregnancy (TWIN-UIC Trial)

N/A
Recruiting
Led By Amanda Roman, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Asymptomatic
Pregnant women more than 18 years of age (limits the participants to female gender)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights

TWIN-UIC Trial Summary

This trial will test if an ultrasound-indicated cerclage reduces the incidence of premature birth in asymptomatic women with twin gestations and a short cervix.

Who is the study for?
This trial is for women over 18 with twin pregnancies, specifically those who have a short cervical length (≤15mm) detected by ultrasound between 16 and nearly 24 weeks of gestation. Participants should not show symptoms. Women with more than two babies, certain twin complications like Twin-twin transfusion syndrome, or any listed conditions that could complicate pregnancy are excluded.Check my eligibility
What is being tested?
The study is testing if placing a stitch around the cervix (cervical cerclage) can prevent premature birth in women carrying twins who have a short cervix. It's done at multiple centers where women are randomly chosen to receive this procedure or not.See study design
What are the potential side effects?
While specific side effects aren't detailed here, cervical cerclage procedures may include risks such as bleeding, infection, or causing contractions which could lead to preterm labor.

TWIN-UIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have any symptoms.
Select...
I am a pregnant woman over 18 years old.

TWIN-UIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Preterm delivery less than 34 weeks
Secondary outcome measures
Birth weight at birth
Chorioamnionitis
Composite adverse neonatal outcome
+8 more

TWIN-UIC Trial Design

2Treatment groups
Active Control
Group I: Cervical cerclage + vaginal progesteroneActive Control1 Intervention
Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
Group II: Vaginal progesteroneActive Control1 Intervention
Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
443 Previous Clinical Trials
145,300 Total Patients Enrolled
Federico II UniversityOTHER
374 Previous Clinical Trials
120,283 Total Patients Enrolled
Amanda Roman, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Cervical cerclage (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03340688 — N/A
Twin Pregnancy Research Study Groups: Cervical cerclage + vaginal progesterone, Vaginal progesterone
Twin Pregnancy Clinical Trial 2023: Cervical cerclage Highlights & Side Effects. Trial Name: NCT03340688 — N/A
Cervical cerclage (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03340688 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment accepting new members at present?

"As per the information provided on clinicaltrials.gov, this trial is currently recruiting participants and was originally posted in June of 2017 with a recent update made to it on April 23rd 2020."

Answered by AI

Is this study open to geriatric participants?

"This trial's eligibility guidelines specify that participants must be aged 18 to 60 years old. For individuals below this age range, there are 184 studies available and 74 for those above the cutoff."

Answered by AI

Could I qualify as a participant for this medical trial?

"This clinical trial aims to recruit 200 participants who experienced a premature birth and are between 18-60 years old. Notably, the inclusion criteria necessitates that they must have had a diamniotic twin pregnancy, be asymptomatic, and must identify with female gender."

Answered by AI

What is the upper limit of participants for this medical experiment?

"Affirmative. Clinicaltrials.gov divulges that this medical trial is presently recruiting, with the first posting dating back to June 22nd 2017 and last updated April 23rd 2020. 200 patients are needed for 3 separate sites."

Answered by AI
Recent research and studies
~5 spots leftby Jun 2024