Trial Outcomes & Findings for Neonatal Outcome by Reason for Delivery (NCT NCT01818518)

Last Updated: 2019-06-18

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

995 participants

Primary outcome timeframe

Infants from birth until discharge or until infant reaches 28 days of life.

Results posted on

2019-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	Preterm Labor Diagnosis on Admission Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission	Pre-eclampsia Diagnosis on Admission The diagnosis of Preeclampsia at time of admission	Intrauterine Growth Restriction (IUGR) Diagnosis on Admission The diagnosis of IUGR at time of admission	Vaginal Bleeding Diagnosis on Admission The diagnosis of vaginal bleeding made at time of admission	Short Cervix Diagnosis on Admission The diagnosis of Short cervical length at time of admission
Overall Study STARTED	310	263	288	59	38	37
Overall Study COMPLETED	310	263	288	59	38	37
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prelabor Rupture of Membranes Diagnosis on Admission n=310 Participants 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	Preterm Labor Diagnosis on Admission n=263 Participants Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission	Pre-eclampsia Diagnosis on Admission n=288 Participants The diagnosis of Preeclampsia at time of admission	IUGR Diagnosis on Admission n=59 Participants The diagnosis of IUGR at time of admission	Vaginal Bleeding Diagnosis on Admission n=38 Participants The diagnosis of vaginal bleeding made at time of admission	Short Cervix Diagnosis on Admission n=37 Participants The diagnosis of Short cervical length at time of admission	Total n=995 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 6.0 • n=310 Participants	28.1 years STANDARD_DEVIATION 6.0 • n=263 Participants	29.9 years STANDARD_DEVIATION 6.5 • n=288 Participants	28.6 years STANDARD_DEVIATION 5.6 • n=59 Participants	28.9 years STANDARD_DEVIATION 6.2 • n=38 Participants	29.4 years STANDARD_DEVIATION 5.6 • n=37 Participants	29.1 years STANDARD_DEVIATION 5.9 • n=995 Participants
Sex: Female, Male Female	310 Participants n=310 Participants	263 Participants n=263 Participants	288 Participants n=288 Participants	59 Participants n=59 Participants	38 Participants n=38 Participants	37 Participants n=37 Participants	995 Participants n=995 Participants
Sex: Female, Male Male	0 Participants n=310 Participants	0 Participants n=263 Participants	0 Participants n=288 Participants	0 Participants n=59 Participants	0 Participants n=38 Participants	0 Participants n=37 Participants	0 Participants n=995 Participants
Race/Ethnicity, Customized White	163 Participants n=299 Participants • 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.	139 Participants n=257 Participants • 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.	142 Participants n=284 Participants • 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.	33 Participants n=59 Participants • 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.	21 Participants n=36 Participants • 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.	19 Participants n=36 Participants • 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.	517 Participants n=971 Participants • 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.
Race/Ethnicity, Customized Hispanic	67 Participants n=299 Participants • 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.	51 Participants n=257 Participants • 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.	61 Participants n=284 Participants • 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.	9 Participants n=59 Participants • 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.	4 Participants n=36 Participants • 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.	5 Participants n=36 Participants • 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.	197 Participants n=971 Participants • 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.
Race/Ethnicity, Customized Black	32 Participants n=299 Participants • 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.	25 Participants n=257 Participants • 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.	35 Participants n=284 Participants • 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.	6 Participants n=59 Participants • 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.	7 Participants n=36 Participants • 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.	8 Participants n=36 Participants • 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.	113 Participants n=971 Participants • 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.
Race/Ethnicity, Customized Asian	11 Participants n=299 Participants • 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.	18 Participants n=257 Participants • 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.	13 Participants n=284 Participants • 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.	3 Participants n=59 Participants • 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.	3 Participants n=36 Participants • 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.	2 Participants n=36 Participants • 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.	50 Participants n=971 Participants • 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.
Race/Ethnicity, Customized Other	37 Participants n=299 Participants • 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.	30 Participants n=257 Participants • 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.	37 Participants n=284 Participants • 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.	8 Participants n=59 Participants • 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.	3 Participants n=36 Participants • 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.	3 Participants n=36 Participants • 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.	118 Participants n=971 Participants • 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.
Region of Enrollment United States	310 participants n=310 Participants	263 participants n=263 Participants	288 participants n=288 Participants	59 participants n=59 Participants	38 participants n=38 Participants	37 participants n=37 Participants	995 participants n=995 Participants
Nulliparity	100 Participants n=292 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.	108 Participants n=255 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.	133 Participants n=282 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.	22 Participants n=59 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.	7 Participants n=33 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.	17 Participants n=35 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.	387 Participants n=956 Participants • number analyzed if different from total number because these characteristic were not captured on all patients. Some baseline data was unknown.
Prenatal Care	290 Participants n=298 Participants • 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	247 Participants n=255 Participants • 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	273 Participants n=284 Participants • 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	57 Participants n=59 Participants • 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	34 Participants n=36 Participants • 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	33 Participants n=36 Participants • 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	934 Participants n=968 Participants • 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
Gestational Age at admission , wks	27.1 weeks STANDARD_DEVIATION 2.7 • n=310 Participants	27.7 weeks STANDARD_DEVIATION 2.6 • n=263 Participants	28.3 weeks STANDARD_DEVIATION 2.2 • n=288 Participants	28.2 weeks STANDARD_DEVIATION 2.3 • n=59 Participants	26.7 weeks STANDARD_DEVIATION 2.9 • n=38 Participants	24.4 weeks STANDARD_DEVIATION 2.3 • n=37 Participants	27.0 weeks STANDARD_DEVIATION 2.5 • n=995 Participants
Gestational Age at delivery, wks	28.5 weeks STANDARD_DEVIATION 2.5 • n=310 Participants	28.1 weeks STANDARD_DEVIATION 2.5 • n=263 Participants	28.9 weeks STANDARD_DEVIATION 2.1 • n=288 Participants	29.1 weeks STANDARD_DEVIATION 2.2 • n=59 Participants	27.4 weeks STANDARD_DEVIATION 2.6 • n=38 Participants	26.3 weeks STANDARD_DEVIATION 2.6 • n=37 Participants	28.1 weeks STANDARD_DEVIATION 2.4 • n=995 Participants
Interval from admission to delivery, wks.	1.4 weeks STANDARD_DEVIATION 1.6 • n=310 Participants	0.4 weeks STANDARD_DEVIATION 0.7 • n=263 Participants	0.6 weeks STANDARD_DEVIATION 0.7 • n=288 Participants	0.9 weeks STANDARD_DEVIATION 1.1 • n=59 Participants	0.7 weeks STANDARD_DEVIATION 1.0 • n=38 Participants	1.8 weeks STANDARD_DEVIATION 2.0 • n=37 Participants	1.0 weeks STANDARD_DEVIATION 1.2 • n=995 Participants
Cesarean delivery	178 Participants n=310 Participants	107 Participants n=263 Participants	268 Participants n=288 Participants	58 Participants n=59 Participants	27 Participants n=38 Participants	22 Participants n=37 Participants	660 Participants n=995 Participants
Received full course of antenatal corticosteroids	138 Participants n=310 Participants	114 Participants n=263 Participants	195 Participants n=288 Participants	32 Participants n=59 Participants	14 Participants n=38 Participants	19 Participants n=37 Participants	512 Participants n=995 Participants
Male newborn	178 Participants n=310 Participants	149 Participants n=263 Participants	145 Participants n=288 Participants	33 Participants n=59 Participants	22 Participants n=38 Participants	24 Participants n=37 Participants	551 Participants n=995 Participants
Primary reason for delivery = spontaneous labor	171 Participants n=310 Participants	228 Participants n=263 Participants	0 Participants n=288 Participants	2 Participants n=59 Participants	11 Participants n=38 Participants	21 Participants n=37 Participants	433 Participants n=995 Participants
Primary reason for delivery = preeclampsia	0 Participants n=310 Participants	0 Participants n=263 Participants	219 Participants n=288 Participants	3 Participants n=59 Participants	0 Participants n=38 Participants	0 Participants n=37 Participants	222 Participants n=995 Participants
Primary reason for delivery = fetal heart rate nonreassuring	54 Participants n=310 Participants	15 Participants n=263 Participants	49 Participants n=288 Participants	42 Participants n=59 Participants	7 Participants n=38 Participants	6 Participants n=37 Participants	173 Participants n=995 Participants
Primary reason for delivery = chorioamnionitis	54 Participants n=310 Participants	12 Participants n=263 Participants	0 Participants n=288 Participants	0 Participants n=59 Participants	0 Participants n=38 Participants	5 Participants n=37 Participants	71 Participants n=995 Participants
Primary reason for delivery = Bleeding	18 Participants n=310 Participants	6 Participants n=263 Participants	8 Participants n=288 Participants	0 Participants n=59 Participants	20 Participants n=38 Participants	1 Participants n=37 Participants	53 Participants n=995 Participants
Primary reason for delivery = Other	13 Participants n=310 Participants	2 Participants n=263 Participants	12 Participants n=288 Participants	12 Participants n=59 Participants	0 Participants n=38 Participants	4 Participants n=37 Participants	43 Participants n=995 Participants

PRIMARY outcome

Timeframe: 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.