Cervical cerclage + vaginal progesterone for Premature Birth

Phase-Based Progress Estimates
Thomas Jefferson University Hospital, Philadelphia, PAPremature Birth+2 MoreCervical cerclage - Procedure
18 - 60
What conditions do you have?

Study 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.

Eligible Conditions
  • Premature Birth
  • Short Cervix Syndrome
  • Twin Pregnancy With Antenatal Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: at delivery

Day 28
Neonatal death
Week 6
Maternal death
Day 28
Composite adverse neonatal outcome
at delivery
Birth weight at birth
Gestational age at spontaneous rupture of membranes
Interval between diagnosis and delivery
Mean gestational age at delivery
Premature rupture of membranes
Preterm delivery less than 34 weeks
Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks
Spontaneous preterm birth rates

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Cervical cerclage + vaginal progesterone
1 of 2
Vaginal progesterone
1 of 2

Active Control

200 Total Participants · 2 Treatment Groups

Primary Treatment: Cervical cerclage + vaginal progesterone · No Placebo Group · N/A

Cervical cerclage + vaginal progesterone
ActiveComparator Group · 1 Intervention: Cervical cerclage · Intervention Types: Procedure
Vaginal progesteroneNoIntervention Group · 1 Intervention: Vaginal progesterone · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at delivery

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
410 Previous Clinical Trials
135,895 Total Patients Enrolled
8 Trials studying Premature Birth
12,703 Patients Enrolled for Premature Birth
Federico II UniversityOTHER
325 Previous Clinical Trials
102,308 Total Patients Enrolled
15 Trials studying Premature Birth
3,574 Patients Enrolled for Premature Birth
Amanda Roman, MDPrincipal InvestigatorThomas Jefferson University
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Premature Birth
30 Patients Enrolled for Premature Birth

Eligibility Criteria

Age 18 - 60 · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pregnant with twins who share the same amniotic sac.
You do not have any noticeable symptoms.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.