Preterm Delivery
Conditions
Keywords
Preterm delivery, Premature delivery, Premature birth
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Obstetrix Medical Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating * Singleton pregnancy * Delivery where the baby is: 1. Stillborn OR 2. Born alive and: * expires before it leaves the delivery room OR * is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery
Exclusion criteria
* Patient less than 18 years of age * Pregnancies that had previously been multiple gestations but where one or more fetuses had died after 12weeks of gestation * Deliveries where the baby is born alive, does not expire in the delivery room but the baby does not get admitted to the NICU.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Perinatal Morbidity | Infants from birth until discharge or until infant reaches 28 days of life. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 310 |
| Preterm Labor Diagnosis on Admission Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission | 263 |
| Pre-eclampsia Diagnosis on Admission The diagnosis of Preeclampsia at time of admission | 288 |
| IUGR Diagnosis on Admission The diagnosis of IUGR at time of admission | 59 |
| Vaginal Bleeding Diagnosis on Admission The diagnosis of vaginal bleeding made at time of admission | 38 |
| Short Cervix Diagnosis on Admission The diagnosis of Short cervical length at time of admission | 37 |
| Total | 995 |
Baseline characteristics
| Characteristic | Short Cervix Diagnosis on Admission | Prelabor Rupture of Membranes Diagnosis on Admission | Preterm Labor Diagnosis on Admission | Pre-eclampsia Diagnosis on Admission | IUGR Diagnosis on Admission | Vaginal Bleeding Diagnosis on Admission | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 5.6 | 29.7 years STANDARD_DEVIATION 6 | 28.1 years STANDARD_DEVIATION 6 | 29.9 years STANDARD_DEVIATION 6.5 | 28.6 years STANDARD_DEVIATION 5.6 | 28.9 years STANDARD_DEVIATION 6.2 | 29.1 years STANDARD_DEVIATION 5.9 |
| Cesarean delivery | 22 Participants | 178 Participants | 107 Participants | 268 Participants | 58 Participants | 27 Participants | 660 Participants |
| Gestational Age at admission , wks | 24.4 weeks STANDARD_DEVIATION 2.3 | 27.1 weeks STANDARD_DEVIATION 2.7 | 27.7 weeks STANDARD_DEVIATION 2.6 | 28.3 weeks STANDARD_DEVIATION 2.2 | 28.2 weeks STANDARD_DEVIATION 2.3 | 26.7 weeks STANDARD_DEVIATION 2.9 | 27.0 weeks STANDARD_DEVIATION 2.5 |
| Gestational Age at delivery, wks | 26.3 weeks STANDARD_DEVIATION 2.6 | 28.5 weeks STANDARD_DEVIATION 2.5 | 28.1 weeks STANDARD_DEVIATION 2.5 | 28.9 weeks STANDARD_DEVIATION 2.1 | 29.1 weeks STANDARD_DEVIATION 2.2 | 27.4 weeks STANDARD_DEVIATION 2.6 | 28.1 weeks STANDARD_DEVIATION 2.4 |
| Interval from admission to delivery, wks. | 1.8 weeks STANDARD_DEVIATION 2 | 1.4 weeks STANDARD_DEVIATION 1.6 | 0.4 weeks STANDARD_DEVIATION 0.7 | 0.6 weeks STANDARD_DEVIATION 0.7 | 0.9 weeks STANDARD_DEVIATION 1.1 | 0.7 weeks STANDARD_DEVIATION 1 | 1.0 weeks STANDARD_DEVIATION 1.2 |
| Male newborn | 24 Participants | 178 Participants | 149 Participants | 145 Participants | 33 Participants | 22 Participants | 551 Participants |
| Nulliparity | 17 Participants | 100 Participants | 108 Participants | 133 Participants | 22 Participants | 7 Participants | 387 Participants |
| Prenatal Care | 33 Participants | 290 Participants | 247 Participants | 273 Participants | 57 Participants | 34 Participants | 934 Participants |
| Primary reason for delivery = Bleeding | 1 Participants | 18 Participants | 6 Participants | 8 Participants | 0 Participants | 20 Participants | 53 Participants |
| Primary reason for delivery = chorioamnionitis | 5 Participants | 54 Participants | 12 Participants | 0 Participants | 0 Participants | 0 Participants | 71 Participants |
| Primary reason for delivery = fetal heart rate nonreassuring | 6 Participants | 54 Participants | 15 Participants | 49 Participants | 42 Participants | 7 Participants | 173 Participants |
| Primary reason for delivery = Other | 4 Participants | 13 Participants | 2 Participants | 12 Participants | 12 Participants | 0 Participants | 43 Participants |
| Primary reason for delivery = preeclampsia | 0 Participants | 0 Participants | 0 Participants | 219 Participants | 3 Participants | 0 Participants | 222 Participants |
| Primary reason for delivery = spontaneous labor | 21 Participants | 171 Participants | 228 Participants | 0 Participants | 2 Participants | 11 Participants | 433 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 11 Participants | 18 Participants | 13 Participants | 3 Participants | 3 Participants | 50 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 32 Participants | 25 Participants | 35 Participants | 6 Participants | 7 Participants | 113 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 67 Participants | 51 Participants | 61 Participants | 9 Participants | 4 Participants | 197 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 37 Participants | 30 Participants | 37 Participants | 8 Participants | 3 Participants | 118 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 163 Participants | 139 Participants | 142 Participants | 33 Participants | 21 Participants | 517 Participants |
| Received full course of antenatal corticosteroids | 19 Participants | 138 Participants | 114 Participants | 195 Participants | 32 Participants | 14 Participants | 512 Participants |
| Region of Enrollment United States | 37 participants | 310 participants | 263 participants | 288 participants | 59 participants | 38 participants | 995 participants |
| Sex: Female, Male Female | 37 Participants | 310 Participants | 263 Participants | 288 Participants | 59 Participants | 38 Participants | 995 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: Infants from birth until discharge or until infant reaches 28 days of life.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Five-minute Apgar score < 5 | 24 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Intraventicular Hemorrhage Grade 3 or 4 | 13 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | On Ventilatory at 28 days of age | 24 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Respiratory distress syndrome (RDS) | 206 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Venous Base Excess < -12 | 2 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Arterial base excess < -12 | 5 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Cord arterial pH < 7.1 | 8 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Serious Morbidity | 82 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Composite Morbidity | 277 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Sepsis | 11 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Cord venous pH <7.1 | 5 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Periventricular Leukomalacia (PVL) | 2 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Necrotizing Enterocolitis | 9 participants |
| Prelabor Rupture of Membranes Diagnosis on Admission | Composite Perinatal Morbidity | Perinatal (infant) Death | 32 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Necrotizing Enterocolitis | 15 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Composite Morbidity | 203 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Serious Morbidity | 68 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Perinatal (infant) Death | 20 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Respiratory distress syndrome (RDS) | 190 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | On Ventilatory at 28 days of age | 28 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Intraventicular Hemorrhage Grade 3 or 4 | 19 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Periventricular Leukomalacia (PVL) | 1 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Sepsis | 5 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Cord arterial pH < 7.1 | 7 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Cord venous pH <7.1 | 5 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Arterial base excess < -12 | 3 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Venous Base Excess < -12 | 4 participants |
| Preterm Labor Diagnosis on Admission | Composite Perinatal Morbidity | Five-minute Apgar score < 5 | 15 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Composite Morbidity | 221 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Sepsis | 6 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Periventricular Leukomalacia (PVL) | 1 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | On Ventilatory at 28 days of age | 29 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Intraventicular Hemorrhage Grade 3 or 4 | 8 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Serious Morbidity | 62 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Venous Base Excess < -12 | 5 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Respiratory distress syndrome (RDS) | 211 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Five-minute Apgar score < 5 | 15 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Arterial base excess < -12 | 6 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Necrotizing Enterocolitis | 14 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Perinatal (infant) Death | 17 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Cord venous pH <7.1 | 9 participants |
| Pre-eclampsia Diagnosis on Admission | Composite Perinatal Morbidity | Cord arterial pH < 7.1 | 14 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Arterial base excess < -12 | 1 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Venous Base Excess < -12 | 1 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Intraventicular Hemorrhage Grade 3 or 4 | 1 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Necrotizing Enterocolitis | 3 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Periventricular Leukomalacia (PVL) | 1 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Serious Morbidity | 20 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Sepsis | 2 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Cord arterial pH < 7.1 | 2 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Cord venous pH <7.1 | 2 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Five-minute Apgar score < 5 | 2 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | On Ventilatory at 28 days of age | 14 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Composite Morbidity | 45 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Respiratory distress syndrome (RDS) | 43 participants |
| IUGR Diagnosis on Admission | Composite Perinatal Morbidity | Perinatal (infant) Death | 6 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Serious Morbidity | 17 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Intraventicular Hemorrhage Grade 3 or 4 | 5 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Cord arterial pH < 7.1 | 5 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Necrotizing Enterocolitis | 5 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Cord venous pH <7.1 | 3 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Composite Morbidity | 28 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Respiratory distress syndrome (RDS) | 23 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Arterial base excess < -12 | 2 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | On Ventilatory at 28 days of age | 11 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Perinatal (infant) Death | 5 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Periventricular Leukomalacia (PVL) | 1 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Venous Base Excess < -12 | 2 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Five-minute Apgar score < 5 | 2 participants |
| Vaginal Bleeding Diagnosis on Admission | Composite Perinatal Morbidity | Sepsis | 1 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Sepsis | 1 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Necrotizing Enterocolitis | 2 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Arterial base excess < -12 | 0 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Intraventicular Hemorrhage Grade 3 or 4 | 8 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Cord arterial pH < 7.1 | 0 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Five-minute Apgar score < 5 | 6 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Venous Base Excess < -12 | 0 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | On Ventilatory at 28 days of age | 10 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Perinatal (infant) Death | 5 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Cord venous pH <7.1 | 0 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Composite Morbidity | 33 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Periventricular Leukomalacia (PVL) | 0 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Serious Morbidity | 20 participants |
| Short Cervix Diagnosis on Admission | Composite Perinatal Morbidity | Respiratory distress syndrome (RDS) | 27 participants |