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

Stopped early · Not applicable

Conditions studied: Preterm Birth

In brief

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.

Key facts

Study ID

NCT03530332

Run by

Ware Branch

People needed

1208

Starts

2018-05-14

Expected to finish

2019-08-30

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subject is greater than or equal to 18 years of age AND
• Uncomplicated singleton intrauterine pregnancy less than 21 weeks estimated gestation AND
• No medical contraindications to continuing pregnancy AND
• No previous classical cesarean section AND
• No known uterine anomaly AND
• No history of cervical conization AND
• No plan for cesarean section prior to 37 0/7 weeks gestation AND
• No plan for induction of labor prior to 37 0/7 weeks gestation AND
• Subject has no history of spontaneous preterm delivery AND
• No prior PPROM less than 34 weeks AND
• Subject has no signs and/or symptoms of preterm labor AND
• Subject has intact membranes AND
• Subject has not received a blood transfusion during the current pregnancy.

You may not qualify if…

• Subjects who have taken or plan to take progesterone beyond 13 6/7 weeks gestation prior to study enrollment OR
• Any other medical conditions that put subject at increased risk of preterm birth in the judgment of the site investigator OR
• The subject has a planned cerclage placement for the current pregnancy OR
• Previously identified short cervix (less than 2.5 cm by transvaginal ultrasound) prior to enrollment OR
• Known major structural fetal anomalies that may shorten pregnancy (e.g., anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia) OR
• Known fetal genetic anomalies that are incompatible with life (e.g., trisomy 13 or trisomy 18) OR
• The subject has known elevated bilirubin levels (hyperbilirubinemia) OR
• The subject has taken or plans to take any of the following medications after the first day of the last menstrual period: Enoxaparin, heparin, heparin sodium, low molecular weight heparin, low dose aspirin OR
• A history of allergic reaction to aspirin or 17-OHPC injections OR
• Subject does not plan to deliver at an Intermountain Healthcare hospital.

Where it is running

• Intermountain Medical Center — Murray, Utah, United States
• McKay-Dee Hospital — Ogden, Utah, United States
• Utah Valley Hospital — Provo, Utah, United States
• LDS Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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