NCT03530332

Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)

Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,208 (actual)
• Sponsor: Ware Branch · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This research study is being done to find out whether a screening blood test can help identify women with an increased risk of preterm birth.

Detailed description

Preterm birth (PTB) remains the leading cause of neonatal mortality and long-term disability throughout the world. Recently treatments early in pregnancy such as progesterone, cervical support and maternal support have been demonstrated to delay delivery amongst at risk women. Nonetheless, the majority of women who are at risk are not identified using current screening methods. Women who are 18 years or older, with a singleton pregnancy between 19 5/7 weeks and 20 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment and no history of prior preterm birth (delivery between 16 0/7 weeks and 37 6/7 weeks) will be invited to participate. Women who enroll will be randomized to screening and intervention for those at high risk of PTB or no screening and standard care. All participants will undergo sample collection, but the samples from the group randomized to "no screening' will not be analyzed until the end of the study (post-delivery of all neonates). Women randomized to the intervention group will be screened using the PreTRM® test (Sera Prognostics, Inc.) at a large tertiary care center. Predicated upon the degree of risk, women will be treated according to a pre-specified algorithm. The outcomes of these women will be compared to a control group of women who do not receive screening at the same tertiary care center.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PreTRM test	Blood test to determine risk of preterm birth

Timeline

• Start date: 2018-05-14
• Primary completion: 2019-02-17
• Completion: 2019-08-30
• First posted: 2018-05-21
• Last updated: 2020-02-17

Locations

4 sites across 1 country: United States