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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to up to 37 weeks gestation (up to 21 weeks)

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.