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Formal Study Name

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

Primary Principal Investigator

Dwight Rouse

Additional Principal Investigator

Brenna Hughes

Study Information

A randomized trial of 600 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.

Studies show women carrying twins are more likely to deliver prior to 37 weeks compared to women carrying one baby. Women with a shortened cervix are more likely to deliver earlier than women with a normal cervical length. Women are offered randomization to:

  • Progesterone suppositories - shown to be effective in singletons with a shortened cervix.
  • Placebo - identical looking medication with no active ingredients.
  • Pessary - a round silicone device that covers the cervix and provides additional support.

See study details at ClinicalTrials.gov.


Eligibility Criteria

Pregnant with twins and shortened cervix prior to 24 weeks.


Compensation/Reimbursement

Patients receive $20 for the randomization visit to compensate for time and travel and an additional $10 at each monthly study visit. Upon delivery patients receive a case of newborn diapers.





Organization
Women & Infants

Area of Study
Maternal Fetal Medicine

Recruitment Status
Open

Recruitment End Date
06/01/2019