Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls: AVERT PRETERM TRIAL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03151330|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : June 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Other: Screened Arm||Not Applicable|
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.
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.
- 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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2110 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Women who are found to have an elevated risk of preterm birth will receive counseling regarding potential interventions and compared to historical controls|
|Masking:||None (Open Label)|
|Official Title:||Serum Assessment of Preterm Birth: Outcomes Compared to Historical Controls|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
This will be an arm of women who are prospectively screened and receive a risk score for preterm birth. They will be recommended treatment strategies and their outcomes compared to an historical control.
Other: Screened Arm
Woman who are identified as high risk will be advised of potential interventions which will include support through care link(nurse education), cervical surveillance, consider vaginal progesterone, low dose aspirin if not already taking.
- Spontaneous preterm birth [ Time Frame: Through pregnancy completion, typically 42 weeks ]Spontaneous preterm delivery before 37 weeks.
- Preterm birth [ Time Frame: Through pregnancy completion, typically 42 weeks ]Preterm birth before 37 weeks
- Total length of hospital stay for any preterm birth [ Time Frame: From birth to 60 days post delivery ]Total length of hospital stay for any preterm birth
- Neonatal death and stillbirth [ Time Frame: Through 42 days post delivery ]Neonatal death and stillbirth
- Birthweight and if birthweight was <1500g [ Time Frame: At time of delivery ]birthweight below 1500 and 2500gm
- Birthweight and if birthweight was <2500gm [ Time Frame: At time of delivery ]birthweight below 2500gm
- Total number of days spent in the NICU and nursery [ Time Frame: Through 60 days post delivery ]total nicu days
- Composite neonatal morbidity score (appendix 3) and components [ Time Frame: Through 60 days post delivery ]Composite neonatal morbidity score composed of Death RDS, IVH, NEC
- Whether or not received surfactant and amount of surfactant [ Time Frame: Through hospitalization or 60 days post delivery ]Whether baby got surfactant
- Occurrence of pneumonia [ Time Frame: Through hospitalization or 60 days post delivery ]Occurrence of pneumonia
- Number of days of mechanical ventilation [ Time Frame: Through hospitalization or 60 days post delivery ]days on mechanical ventilation
- Occurrence of 5 minute Apgar<7 [ Time Frame: At time of birth ]low apgar as defined
- Occurrence of asphyxia, diagnosed either via intrapartum cord gas or via clinical findings [ Time Frame: At tiem of birth ]Occurrence of asphyxia,
- Occurrence of preterm delivery at <37, <35 and <32 weeks [ Time Frame: At time of birth ]Occurrence of preterm delivery at <37, <35 and <32 weeks
- Occurrence of preeclampsia [ Time Frame: Through 60 days post delivery ]preeclampsia as defined by ACOG
- Progesterone levels determined by LC-MS [ Time Frame: at 32 weeks ]progesterone levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151330
|Contact: Matthew k Hoffman, MD||302 733-3350||Mhoffman@christianacare.org|
|Contact: Kelly a Ruhthstaller, MD||302733-3350||Kruthstaller@christianacare.org|
|United States, Delaware|
|Newark, Delaware, United States, 19718|
|Contact: Matthew K Hoffman, MD 302-733-3350 firstname.lastname@example.org|
|Contact: carrie Kitto, BA (302) 733-2379 email@example.com|
|Principal Investigator:||Mattehw K Hoffman`, MD||ChristianaCare|