Population: Women who are 18 years or older, with a singleton pregnancy between 195/7 weeks and 206/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, and no history of prior preterm birth (delivery between 160/7 weeks and 366/7 weeks) will be invited to participate. A comparable population will be identified using a historical control group in a contemporaneously maintained database.
Intervention: Qualifying women 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 prespecified algorithm. The outcomes of these women will be compared to a historical control group at the same tertiary care center.
Outcomes:
Primary outcome: Co-Primary outcomes: To determine whether a cohort of women who are screened with the PreTRM® test and then managed according to a prespecified protocol will have statistically significant reductions in either (a) composite neonatal morbidity and mortality (NMI score), or (b) length of neonatal hospital stay (NNOLOS), compared to a historical control group. The NMI is defined below
DEFINITIONS OF COMPOSITE PERINATAL MORTALITY/NEONATAL MORBIDITY OUTCOME SCORES:
1\) 0 to 4 scale without NICU: This score was derived as an ordinal scale based upon severity. The score was defined by the following: 0 = no events;
1. = one event for (RDS, BPD, grade III or IV IVH, PVL, proven sepsis, or NEC) and no perinatal mortality,
2. = two events and no perinatal mortality;
3. = three or more events and no perinatal mortality; 4=perinatal mortality.
2\) 0 to 4 scale with NICU: This score was defined as the following: 0 = no events,
1. = one event for (RDS, BPD, grade III or IV IVH, PVL, proven sepsis, or NEC) or \<5 days in the NICU, and no perinatal mortality;
2. = two events or between 5 and 20 days in the NICU, and no perinatal mortality;
3. = three or more events or \>20 days in the NICU, and no perinatal mortality;
4. = perinatal mortality.
3\) 0 to 6 scale without NICU: This score was defined as the following: 0 = no events;
1. = one event for (RDS, BPD, grade III or IV IVH, proven sepsis, or NEC) and no perinatal mortality,
2. = two events and no perinatal mortality;
3. = three events and no perinatal mortality;
4. = four events and no perinatal mortality;
5. = five events and no perinatal mortality;
6. = perinatal mortality.
4\) Any morbidity or mortality event: (yes/no)
* Adapted from Hassan SS, et al. Ultrasound Obstet Gynecol 2011; 38:18-31 Supplementary Information
Secondary outcomes: To determine whether women who are screened with the PreTRM® test and then managed according to a pre-specified treatment algorithm will have a statistically significant reduction in proportion of any type of preterm births (spontaneous and indicated), the total length of hospital stay for spontaneous preterm births, and total length of hospital stay for any preterm birth.
Observations:
* Neonatal death and stillbirth
* Birth weight and number of subjects with birth weight \<1500g and \<2500g
* Total number of days spent in the NICU and nursery
* Composite neonatal morbidity score and components
* Whether or not received surfactant
* Occurrence of pneumonia
* Number of days of mechanical ventilation
* Number of subjects with 5 minute Apgar \< 7
* Occurrence of asphyxia
* Number of preterm deliveries at \<37, \<35 and \<32 weeks
* Occurrence of preeclampsia
* Proportion of primiparous women experiencing preterm birth and spontaneous preterm birth
* NICU days for spontaneous preterm birth in primiparous women in prospective treatment arm are significantly less than NICU days in primiparous women in the control group of sPTB
* Correlation of blood levels of 17-OHPC and other progestin levels to outcomes and observations
General Outcomes:
Total cost of hospital care for both the mother and fetus beginning at initiation of care through primary delivery and 28 days of life.
