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NCT01818518 · ClinicalTrials.gov registry record
Neonatal Outcome by Reason for Delivery
A clinical trial, sponsored by Obstetrix Medical Group.
- Completed
- Registry status
- 995
- Enrollment target
NCT01818518: Completed study, sponsored by Obstetrix Medical Group.
NCT01818518 is a clinical trial that has completed, run by Obstetrix Medical Group. The registered enrollment target is 995 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01818518 has completed, sponsored by Obstetrix Medical Group.
- COMPLETED
- Registry status
- 995 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 995 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-07-25 |
What the finished NCT01818518 record still lists
NCT01818518 is an observational study that tracks outcomes without assigning an intervention. The registered 995 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01818518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01818518 about?
NCT01818518 is a clinical study titled "Neonatal Outcome by Reason for Delivery". 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 diagno...
What is the current status of trial NCT01818518?
This trial is currently completed. The enrollment target is 995 participants. The study started on 2013-07. Estimated completion is 2016-07-25.
Who is sponsoring clinical trial NCT01818518?
This trial is sponsored by Obstetrix Medical Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
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