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Title
PROSPECT

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

Organization
Women & Infants

Research Type
Clinical

Primary Principal Investigator

Additional Principal Investigator

Area of Study
Maternal Fetal Medicine


Eligibility Criteria

Pregnant with twins and shortened cervix prior to 24 weeks.


Recruitment Status
Open

Recruitment End Date
06/01/2019

Study Start Date
10/01/2015

Description

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.


Contact Information

Phone: Research Pager 401-452-6614 or Research Hotline 401-274-1122 ext 41533

Email: dallard@wihri.org


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.