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To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.
This is a prospective, observational study that will use information from the medical records of mothers and their newborns. This study seeks to determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.
Secondary Objectives: 1) Difference in mortality between the PTL and PROM groups, composite morbidity differences for other reasons for premature delivery, and individual morbidities including IVH, PVL, RDS, sepsis, seizures, BPD and NEC
Study Population: All babies from singleton pregnancies delivering in each of the involved hospitals who deliver at less than 32 weeks of gestation who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.
Planned Sample Size: We plan a two year study and estimate based on historical data for the institutions to be included in the study, which should yield approximately 6000 babies less than (<) 32w0d gestation. For a 10% difference in composite morbidity (assuming 90% power and two-sided alpha=0.05) assuming a rate of 60% at least 661 patients are needed in each of the 3 groups (PTL, PROM, and other).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm Labor | Group who goes into labor prior to 32 weeks of gestation | ||
| Prelabor rupture of membranes | Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor. | ||
| Premature birth before 32 weeks gestation | Premature birth before 32 weeks gestation not including PTL or PROM |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Perinatal Morbidity | The primary outcome is Composite Perinatal Morbidity. Composite morbidity refers to the newborns born to the female participants enrolled in the study. Composite Morbidity is defined as ≥ 1 of the following: respiratory distress syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge). | Infants from birth until discharge or until infant reaches 28 days of life. |
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Inclusion Criteria:
Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating
Singleton pregnancy
Delivery where the baby is:
expires before it leaves the delivery room OR
is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery
Exclusion Criteria:
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All babies from singleton pregnancies delivering in each of the involved hospitals who delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Garite, MD | Obstetrix Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Desert Medical Center | Mesa | Arizona | 85210 | United States | ||
| Banner Good Samaritan Medical Center |
undecided
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| ID | Title | Description |
|---|---|---|
| FG000 | Prelabor Rupture of Membranes Diagnosis on Admission | Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission |
| FG001 | Preterm Labor Diagnosis on Admission | Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission |
| FG002 | Pre-eclampsia Diagnosis on Admission | The diagnosis of Preeclampsia at time of admission |
| FG003 | Intrauterine Growth Restriction (IUGR) Diagnosis on Admission | The diagnosis of IUGR at time of admission |
| FG004 | Vaginal Bleeding Diagnosis on Admission | The diagnosis of vaginal bleeding made at time of admission |
| FG005 | Short Cervix Diagnosis on Admission | The diagnosis of Short cervical length at time of admission |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prelabor Rupture of Membranes Diagnosis on Admission | Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission |
| BG001 | Preterm Labor Diagnosis on Admission |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Perinatal Morbidity | The primary outcome is Composite Perinatal Morbidity. Composite morbidity refers to the newborns born to the female participants enrolled in the study. Composite Morbidity is defined as ≥ 1 of the following: respiratory distress syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge). | Composite morbidity is defined as ≥ 1 of the following: RDS, BPD, severe IVH (grades III or IV), PVL, blood culture-proven sepsis present within 72 hours of birth, NEC, or perinatal death. Perinatal Morbidity assessed pertains to the newborns born to the enrolled female patients. | Posted | Number | participants | Infants from birth until discharge or until infant reaches 28 days of life. |
|
No adverse events were assessed from the beginning through the duration of the study. This is an observational study and therefore adverse events were not assessed.
All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed in this observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preterm Labor | Group who goes into labor prior to 32 weeks of gestation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Maurel | Mednax. Inc | 714-593-9171 | kimberly_maurel@mednax.com |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Scottsdale Healthcare-Shea Medical Center | Scottsdale | Arizona | 85260 | United States |
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | United States |
| Good Samaritan Hospital | San Jose | California | 95008 | United States |
| Presbyterian/St Luke's Hospital | Denver | Colorado | 80218 | United States |
| Saint Luke's Hospital, Kansas City | Kansas City | Missouri | 64111 | United States |
| Mercy Hospital of St. Louis | St Louis | Missouri | 63141 | United States |
| Harris Methodist Hospital - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | United States |
Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission |
| BG002 | Pre-eclampsia Diagnosis on Admission | The diagnosis of Preeclampsia at time of admission |
| BG003 | IUGR Diagnosis on Admission | The diagnosis of IUGR at time of admission |
| BG004 | Vaginal Bleeding Diagnosis on Admission | The diagnosis of vaginal bleeding made at time of admission |
| BG005 | Short Cervix Diagnosis on Admission | The diagnosis of Short cervical length at time of admission |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants were able to indicate more than one Race/Ethnicity in their response. | Not all ethnicity data was available for all participants enrolled in the study and participants were able to select more than one Race/Ethnicity when applicable. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nulliparity | number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown. | Count of Participants | Participants |
|
| Prenatal Care | Measure Analysis Population Description: number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown | Count of Participants | Participants |
|
| Gestational Age at admission , wks | Mean | Standard Deviation | weeks |
|
| Gestational Age at delivery, wks | Mean | Standard Deviation | weeks |
|
| Interval from admission to delivery, wks. | Mean | Standard Deviation | weeks |
|
| Cesarean delivery | Count of Participants | Participants |
|
| Received full course of antenatal corticosteroids | A full course was determined by evaluation of the medical record to verify that two doses of antenatal corticosteroid prior to rupture of membranes and each dose was administered 24 hours apart. | Count of Participants | Participants |
|
| Male newborn | Count of Participants | Participants |
|
| Primary reason for delivery = spontaneous labor | Count of Participants | Participants |
|
| Primary reason for delivery = preeclampsia | Count of Participants | Participants |
|
| Primary reason for delivery = fetal heart rate nonreassuring | Count of Participants | Participants |
|
| Primary reason for delivery = chorioamnionitis | Count of Participants | Participants |
|
| Primary reason for delivery = Bleeding | Count of Participants | Participants |
|
| Primary reason for delivery = Other | Count of Participants | Participants |
|
| OG000 | Prelabor Rupture of Membranes Diagnosis on Admission | Group who have prelabor rupture of membranes (PROM) are those who break their bag of water prior to 32 weeks gestation in the absence of labor. Diagnosis made on admission |
| OG001 | Preterm Labor Diagnosis on Admission | Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission |
| OG002 | Pre-eclampsia Diagnosis on Admission | The diagnosis of Preeclampsia at time of admission |
| OG003 | IUGR Diagnosis on Admission | The diagnosis of IUGR at time of admission |
| OG004 | Vaginal Bleeding Diagnosis on Admission | The diagnosis of vaginal bleeding made at time of admission |
| OG005 | Short Cervix Diagnosis on Admission | The diagnosis of Short cervical length at time of admission |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Prelabor Rupture of Membranes | Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | IUGR Diagnosis on Admission | Group who have the diagnosis of intrauterine growth restriction on admission to the hospital. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Pre-Eclampsia Diagnosis on Admission | Group who have the diagnosis of pre-eclampsia noted on admission to the hospital | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Vaginal Bleeding Diagnosis on Admission | Group who have the presence of vaginal bleeding noted at the time of admission to the hospital | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Short Cervix Diagnosis on Admission | Group who have the diagnosis of a short cervical length at the time of admission to the hospital | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000091642 | Urogenital Diseases |
| Male |
|
|
|
|
|