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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
Must not have
Known liver dysfunction or disease because liver disease is a contraindication to the active study medication
Fetal anomaly in either twin or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project EDC (estimated date of conception) must be performed prior to randomization to evaluate the fetuses for anomalies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to up to 37 weeks gestation (up to 21 weeks)
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have liver disease.
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My unborn baby or babies have been diagnosed with a serious health condition.
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I am not allergic to progesterone, silicone, peanuts, or any ingredients in the study drug.
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I do not have a current or past diagnosis of breast cancer.
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I currently have an active herpes sore in my genital area.
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I have a specific abnormal uterus shape that increases my risk of early delivery.
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I have or will have a cerclage, preventing me from using a pessary.
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I have placenta previa, which increases my risk of bleeding and early birth.

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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
26 Previous Clinical Trials
110,702 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
2,068 Previous Clinical Trials
2,746,914 Total Patients Enrolled
2 Trials studying Short Cervix
1,009 Patients Enrolled for Short Cervix
Andrew Bremer, M.D., PhD, MASStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Monica Longo, MDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
8 Previous Clinical Trials
47,449 Total Patients Enrolled
1 Trials studying Short Cervix
544 Patients Enrolled for Short Cervix
Joseph Biggio, MDStudy ChairMaternal Fetal Medicine Units (MFMU) Network
1 Previous Clinical Trials
1,210 Total Patients Enrolled

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
~17 spots leftby Mar 2025
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