Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls: AVERT PRETERM TRIAL
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | June 15, 2018 |
| End Date: | December 1, 2019 |
| Contact: | Matthew k Hoffman, MD |
| Email: | Mhoffman@christianacare.org |
| Phone: | 302 733-3350 |
Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls
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: Women who are screened using the PreTRM® test around 20 weeks gestation will have
a -statistically significant reduction in preterm birth compared to an unscreened historical
control group of preterm birth.
Study Design Type: Prospective cohort study of screened women compared to a historical
control. The study will employ an adaptive design allowing periodic evaluation of the data to
determine the optimal time to stop the study.
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: Women who are screened using the PreTRM® test around 20 weeks gestation will have
a -statistically significant reduction in preterm birth compared to an unscreened historical
control group of preterm birth.
Study Design Type: Prospective cohort study of screened women compared to a historical
control. The study will employ an adaptive design allowing periodic evaluation of the data to
determine the optimal time to stop the study.
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: To determine whether women who are screened with the PreTRM® test and then
managed according to a prespecified algorithm will have a statistically significant reduction
in spontaneous PTB < 37 weeks compared to a historical control group.
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.
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: To determine whether women who are screened with the PreTRM® test and then
managed according to a prespecified algorithm will have a statistically significant reduction
in spontaneous PTB < 37 weeks compared to a historical control group.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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