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Pessary + Progesterone for Preventing Preterm Birth in Twins (PROSPECT Trial)

Phase 3
Recruiting
Research Sponsored by The George Washington University Biostatistics Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to up to 37 weeks gestation (up to 21 weeks)
Awards & highlights

PROSPECT Trial Summary

This trial looks at whether a progesterone supplement can help prevent early preterm birth in pregnant women carrying twins and who have a short cervix.

Who is the study for?
This trial is for pregnant women with twin gestations, between 16 and 23 weeks along, who have a cervix shorter than 30 mm. It's not for those with placenta previa, serious maternal illnesses, planned cerclage or existing cerclage, monoamniotic twins, twin-twin transfusion syndrome, severe IUGR in either fetus, major fetal anomalies or imminent demise of a fetus.Check my eligibility
What is being tested?
The study tests if micronized vaginal progesterone or an Arabin pessary can prevent early preterm birth in women carrying twins with a short cervix compared to placebo. A total of 630 participants will be randomly assigned to one of these interventions.See study design
What are the potential side effects?
Potential side effects may include local irritation from the pessary or progesterone application site reactions. Since this involves standard treatments and placebos being tested for new indications (preventing preterm labor), other specific side effects are not detailed but could align with typical pregnancy-related symptoms.

PROSPECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to up to 37 weeks gestation (up to 21 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to up to 37 weeks gestation (up to 21 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Delivery or fetal loss of either twin prior to 35 weeks gestation
Secondary outcome measures
Cesarean delivery
Composite neonatal outcome
Fetal or neonatal death
+7 more

PROSPECT Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: ProgesteroneActive Control1 Intervention
200mg micronized vaginal progesterone softgel capsule, daily from randomization to < 35 wks
Group II: Arabin PessaryActive Control1 Intervention
placement management from randomization to < 35 wks
Group III: PlaceboPlacebo Group1 Intervention
placebo softgel capsule, daily from randomization to < 35 wks

Find a Location

Who is running the clinical trial?

The George Washington University Biostatistics CenterLead Sponsor
23 Previous Clinical Trials
102,330 Total Patients Enrolled
1 Trials studying Short Cervix
544 Patients Enrolled for Short Cervix
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,967 Previous Clinical Trials
2,672,267 Total Patients Enrolled
2 Trials studying Short Cervix
1,009 Patients Enrolled for Short Cervix
Monica Longo, MDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
8 Previous Clinical Trials
48,949 Total Patients Enrolled
1 Trials studying Short Cervix
544 Patients Enrolled for Short Cervix

Media Library

Arabin Pessary Clinical Trial Eligibility Overview. Trial Name: NCT02518594 — Phase 3
Short Cervix Research Study Groups: Progesterone, Placebo, Arabin Pessary
Short Cervix Clinical Trial 2023: Arabin Pessary Highlights & Side Effects. Trial Name: NCT02518594 — Phase 3
Arabin Pessary 2023 Treatment Timeline for Medical Study. Trial Name: NCT02518594 — Phase 3

Frequently Asked Questions

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

Does this research project have a lot of participating hospitals in our state?

"Patients are being accepted at the University of North carolina - Chapel Hill, Ohio State University, and the University of Alabama - Birmingham. Along with these 10 other locations, these are a few notable medical centres where the study is taking place."

Answered by AI

Has Progesterone been cleared by the FDA?

"Progesterone has been deemed safe by our analysts at Power. This is due to the fact that progesterone is a Phase 3 trial drug, meaning that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

What are some of the common medical conditions that Progesterone is used to help manage?

"Uterine hemorrhage, hormonal imbalance, and recurrent spontaneous preterm birth can all be effectively treated with Progesterone."

Answered by AI

Does Progesterone have a history of being studied in a laboratory setting?

"Currently, there are 45 clinical trials studying Progesterone with 8 trials in Phase 3. Progesterone trials are taking place in Barcelona, Catalunya as well as an additional 258 locations."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Columbia University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
2015. "A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02518594.
All > Rhode Island > Utah
~56 spots leftby Mar 2025
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