Neonatal Outcome by Reason for Delivery

• Sponsor: Obstetrix Medical Group (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01818518
• Collaborator: (none)
• Enrollment: 995
• Locations: 10
• Actual Duration (Months): 36.8
• Patients Per Site: 99.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Delivery

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 995 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 3, 2016
• Actual Study Completion Date: Jul 25, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Desert Medical Center	Mesa	Arizona	United States	85210
2	Banner Good Samaritan Medical Center	Phoenix	Arizona	United States	85006
3	Scottsdale Healthcare-Shea Medical Center	Scottsdale	Arizona	United States	85260
4	Saddleback Memorial Medical Center	Laguna Hills	California	United States	92653
5	Good Samaritan Hospital	San Jose	California	United States	95008
6	Presbyterian/St Luke's Hospital	Denver	Colorado	United States	80218
7	Saint Luke's Hospital, Kansas City	Kansas City	Missouri	United States	64111
8	Mercy Hospital of St. Louis	Saint Louis	Missouri	United States	63141
9	Harris Methodist Hospital - Fort Worth	Fort Worth	Texas	United States	76104
10	Swedish Medical Center	Seattle	Washington	United States	98122-4307

Sponsors and Collaborators

• Obstetrix Medical Group

Investigators

• Principal Investigator: Thomas Garite, MD, Obstetrix Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Obstetrix Medical Group
• ClinicalTrials.gov Identifier: NCT01818518
• Other Study ID Numbers: OBX0022
• First Posted: Mar 26, 2013
• Last Update Posted: Jun 18, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Obstetrix Medical Group: Preterm delivery; Premature delivery; Premature birth
• Additional relevant MeSH terms: Premature Birth

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	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	Short Cervix Diagnosis on Admission	Total
Arm/Group Description	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	Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission	The diagnosis of Preeclampsia at time of admission	The diagnosis of IUGR at time of admission	The diagnosis of vaginal bleeding made at time of admission	The diagnosis of Short cervical length at time of admission	Total of all reporting groups
Overall Participants	310	263	288	59	38	37	995
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (6.0)	28.1 (6.0)	29.9 (6.5)	28.6 (5.6)	28.9 (6.2)	29.4 (5.6)	29.1 (5.9)
Sex: Female, Male (Count of Participants)
Female	310 100%	263 100%	288 100%	59 100%	38 100%	37 100%	995 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	163 52.6%	139 52.9%	142 49.3%	33 55.9%	21 55.3%	19 51.4%	517 52%
Hispanic	67 21.6%	51 19.4%	61 21.2%	9 15.3%	4 10.5%	5 13.5%	197 19.8%
Black	32 10.3%	25 9.5%	35 12.2%	6 10.2%	7 18.4%	8 21.6%	113 11.4%
Asian	11 3.5%	18 6.8%	13 4.5%	3 5.1%	3 7.9%	2 5.4%	50 5%
Other	37 11.9%	30 11.4%	37 12.8%	8 13.6%	3 7.9%	3 8.1%	118 11.9%
Region of Enrollment (participants) [Number]
United States	310 100%	263 100%	288 100%	59 100%	38 100%	37 100%	995 100%
Nulliparity (Count of Participants)
Count of Participants [Participants]	100 32.3%	108 41.1%	133 46.2%	22 37.3%	7 18.4%	17 45.9%	387 38.9%
Prenatal Care (Count of Participants)
Count of Participants [Participants]	290 93.5%	247 93.9%	273 94.8%	57 96.6%	34 89.5%	33 89.2%	934 93.9%
Gestational Age at admission , wks (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	27.1 (2.7)	27.7 (2.6)	28.3 (2.2)	28.2 (2.3)	26.7 (2.9)	24.4 (2.3)	27.0 (2.5)
Gestational Age at delivery, wks (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	28.5 (2.5)	28.1 (2.5)	28.9 (2.1)	29.1 (2.2)	27.4 (2.6)	26.3 (2.6)	28.1 (2.4)
Interval from admission to delivery, wks. (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	1.4 (1.6)	0.4 (0.7)	0.6 (0.7)	0.9 (1.1)	0.7 (1.0)	1.8 (2.0)	1.0 (1.2)
Cesarean delivery (Count of Participants)
Count of Participants [Participants]	178 57.4%	107 40.7%	268 93.1%	58 98.3%	27 71.1%	22 59.5%	660 66.3%
Received full course of antenatal corticosteroids (Count of Participants)
Count of Participants [Participants]	138 44.5%	114 43.3%	195 67.7%	32 54.2%	14 36.8%	19 51.4%	512 51.5%
Male newborn (Count of Participants)
Count of Participants [Participants]	178 57.4%	149 56.7%	145 50.3%	33 55.9%	22 57.9%	24 64.9%	551 55.4%
Primary reason for delivery = spontaneous labor (Count of Participants)
Count of Participants [Participants]	171 55.2%	228 86.7%	0 0%	2 3.4%	11 28.9%	21 56.8%	433 43.5%
Primary reason for delivery = preeclampsia (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	219 76%	3 5.1%	0 0%	0 0%	222 22.3%
Primary reason for delivery = fetal heart rate nonreassuring (Count of Participants)
Count of Participants [Participants]	54 17.4%	15 5.7%	49 17%	42 71.2%	7 18.4%	6 16.2%	173 17.4%
Primary reason for delivery = chorioamnionitis (Count of Participants)
Count of Participants [Participants]	54 17.4%	12 4.6%	0 0%	0 0%	0 0%	5 13.5%	71 7.1%
Primary reason for delivery = Bleeding (Count of Participants)
Count of Participants [Participants]	18 5.8%	6 2.3%	8 2.8%	0 0%	20 52.6%	1 2.7%	53 5.3%
Primary reason for delivery = Other (Count of Participants)
Count of Participants [Participants]	13 4.2%	2 0.8%	12 4.2%	12 20.3%	0 0%	4 10.8%	43 4.3%

Outcome Measures

1. Primary Outcome

Title	Composite Perinatal Morbidity
Description	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.

Outcome Measure Data

Analysis Population Description

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/Group Title	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	Short Cervix Diagnosis on Admission
Arm/Group Description	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	Group who goes into labor prior to 32 weeks of gestation. Diagnosis was made on admission	The diagnosis of Preeclampsia at time of admission	The diagnosis of IUGR at time of admission	The diagnosis of vaginal bleeding made at time of admission	The diagnosis of Short cervical length at time of admission
Measure Participants	310	263	288	59	38	37
Composite Morbidity	277 89.4%	203 77.2%	221 76.7%	45 76.3%	28 73.7%	33 89.2%
Serious Morbidity	82 26.5%	68 25.9%	62 21.5%	20 33.9%	17 44.7%	20 54.1%
Perinatal (infant) Death	32 10.3%	20 7.6%	17 5.9%	6 10.2%	5 13.2%	5 13.5%
Respiratory distress syndrome (RDS)	206 66.5%	190 72.2%	211 73.3%	43 72.9%	23 60.5%	27 73%
On Ventilatory at 28 days of age	24 7.7%	28 10.6%	29 10.1%	14 23.7%	11 28.9%	10 27%
Intraventicular Hemorrhage Grade 3 or 4	13 4.2%	19 7.2%	8 2.8%	1 1.7%	5 13.2%	8 21.6%
Necrotizing Enterocolitis	9 2.9%	15 5.7%	14 4.9%	3 5.1%	5 13.2%	2 5.4%
Periventricular Leukomalacia (PVL)	2 0.6%	1 0.4%	1 0.3%	1 1.7%	1 2.6%	0 0%
Sepsis	11 3.5%	5 1.9%	6 2.1%	2 3.4%	1 2.6%	1 2.7%
Cord arterial pH < 7.1	8 2.6%	7 2.7%	14 4.9%	2 3.4%	5 13.2%	0 0%
Cord venous pH <7.1	5 1.6%	5 1.9%	9 3.1%	2 3.4%	3 7.9%	0 0%
Arterial base excess < -12	5 1.6%	3 1.1%	6 2.1%	1 1.7%	2 5.3%	0 0%
Venous Base Excess < -12	2 0.6%	4 1.5%	5 1.7%	1 1.7%	2 5.3%	0 0%
Five-minute Apgar score < 5	24 7.7%	15 5.7%	15 5.2%	2 3.4%	2 5.3%	6 16.2%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed in this observational study.
Arm/Group Title	Preterm Labor		Prelabor Rupture of Membranes		IUGR Diagnosis on Admission		Pre-Eclampsia Diagnosis on Admission		Vaginal Bleeding Diagnosis on Admission		Short Cervix Diagnosis on Admission
Arm/Group Description	Group who goes into labor prior to 32 weeks of gestation		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.		Group who have the diagnosis of intrauterine growth restriction on admission to the hospital.		Group who have the diagnosis of pre-eclampsia noted on admission to the hospital		Group who have the presence of vaginal bleeding noted at the time of admission to the hospital		Group who have the diagnosis of a short cervical length at the time of admission to the hospital
All Cause Mortality
	Preterm Labor		Prelabor Rupture of Membranes		IUGR Diagnosis on Admission		Pre-Eclampsia Diagnosis on Admission		Vaginal Bleeding Diagnosis on Admission		Short Cervix Diagnosis on Admission
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Preterm Labor		Prelabor Rupture of Membranes		IUGR Diagnosis on Admission		Pre-Eclampsia Diagnosis on Admission		Vaginal Bleeding Diagnosis on Admission		Short Cervix Diagnosis on Admission
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Preterm Labor		Prelabor Rupture of Membranes		IUGR Diagnosis on Admission		Pre-Eclampsia Diagnosis on Admission		Vaginal Bleeding Diagnosis on Admission		Short Cervix Diagnosis on Admission
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.