N/A
Completed N=995
Neonatal Outcome by Reason for Delivery
Source: ClinicalTrials.gov NCT01818518 ↗Enrolled (actual)
995
Serious AEs
—
Results posted
Jun 2019
Primary outcomePrimary: Composite Perinatal Morbidity — 277; 203; 221; 45 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Perinatal Morbidity |
277; 203; 221; 45; 28; 33 | — |
Eligibility Criteria
Inclusion Criteria
- Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating
- Singleton pregnancy
- Delivery where the baby is:
- Stillborn OR
- 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.
Data sourced from ClinicalTrials.gov (NCT01818518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.