Ignite Creation Date:
2024-05-06 @ 10:04 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03151330
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2017-04-22
Brief Title:
Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls AVERT PRETERM TRIAL
Sponsor:
Christiana Care Health Services
Organization:
Christiana Care Health Services
Study Overview
Official Title:
Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 morbidityand 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
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 morbidityand 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
Detailed Description:
Population Women who are 18 years or older with a singleton pregnancy between 1957 weeks and 2067 weeks gestational age GA confirmed by ultrasound prior to enrollment and no history of prior preterm birth delivery between 1607 weeks and 3667 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 MORTALITYNEONATAL 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 4perinatal 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 yesno
Adapted from Hassan SS et al Ultrasound Obstet Gynecol 2011 3818-31 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
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 MORTALITYNEONATAL 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 4perinatal 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 yesno
Adapted from Hassan SS et al Ultrasound Obstet Gynecol 2011 3818-31 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None