CompletedPhase 3

A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

United States1,311 participantsStarted 2015-11-13

Plain-language summary

This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Who can participate

SexFEMALE

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Inclusion criteria

✓. Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred by 13 weeks 6 days project gestational age.
✓. Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
✓. Cervical length on transvaginal examination of less than 30 mm by a study certified sonographer.

Exclusion criteria

✕. Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization. There is no lower threshold of cervical length measurement threshold on ultrasound that is an exclusion criterion.
✕. Monoamniotic gestation, due to increased risk of adverse pregnancy outcome
✕. Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome
✕. Evidence of severe IUGR (intrauterine growth restriction) (\<5th percentile for gestational age) in either fetus
✕. 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.
✕. Placenta previa, because of risk of bleeding and high potential for indicated preterm birth
✕. Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement.
✕. Symptomatic, untreated vaginal or cervical infection, also because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized.

What they're measuring

Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation

Timeframe: From randomization to 35 weeks gestation (a period of up to 19 weeks)

Trial details

NCT IDNCT02518594

SponsorThe George Washington University Biostatistics Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-15

Results submitted2026-01-27

View on ClinicalTrials.gov More Short Cervical Length trials