Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls: AVERT PRETERM TRIAL

Completed · Not applicable

Conditions studied: Preterm Birth

In brief

Background: 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 modalities. Hypothesis: A cohort of pregnancies who are screened using the PreTRM® test around 20 weeks gestation in which a bundle of interventions is given for elevated PreTRM® risk will show either decreased neonatal morbidity/and mortality (measured as a composite score, "NMI"), or decreased length of neonatal stay in the hospital (NNOLOS). Secondarily, they will show an increase in gestational age at birth (GAB) and a reduction in length of neonatal NICU stay (NICULOS), compared to an unscreened historical control group. Study Design Type: Prospective cohort study of screened women compared to a historical control of 10000 women.

Key facts

Study ID

NCT03151330

Run by

Christiana Care Health Services

People needed

1873

Starts

2018-06-15

Expected to finish

2024-06-01

Last updated by the study team

2024-08-05

Who can join

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

You may qualify if…

• Women 18 years of age or older
• Singleton intrauterine pregnancy
• No medical contraindications to continuing pregnancy
• Subject has no signs and/or symptoms of preterm labor and has intact membranes
• Planned delivery at Christiana Care Health System,
• English speaking as consents from other languages will not be provided.

You may not qualify if…

• Women who have taken or plan to take progesterone beyond 14weeks gestation prior to study enrollment
• Previous history of sPTB less than37 weeks gestation or PPROM less than34 weeks gestation
• Multiple gestations-including a pregnancy that is now a single fetus due to a reduction procedure, vanishing twin, etc
• Known fetal genetic anomalies that are incompatible with life. Examples would include trisomy 13 and trisomy 18. Others would be left to the discretion of the site investigators
• Any other medical conditions that may be considered a contraindication per the judgment of the site investigator
• The subject has a planned cesarean section or induction of labor prior to 370/7 weeks of gestation
• The subject has a planned cerclage placement for the current pregnancy
• Major structural anomalies that may shorten pregnancy- examples would include anencephaly, holoprosencephaly, schizencephaly, gastroschisis, omphalocele, congenital diaphragmatic hernia, pyloric stenosis, etc. Minor anomalies such as polydactyly, unilateral hydronephrosis are not viewed as exclusions. Others would be left to the discretion of the site investigators
• History of cervical conization
• The subject has a uterine anomaly, History of classical cesarean section in a previous pregnancy
• The subject has had a blood transfusion during the current pregnancy
• The subject has known elevated bilirubin levels (hyperbilirubinemia)
• Previously identified short cervix (< 2.5 cm by TVUS)
• 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 or the subject has a history of allergic reaction to aspirin or progesterone.

Where it is running

• Christiana Hospital — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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