Preterm DeliveryNCT01818518

Neonatal Outcome by Reason for Delivery

An observational study of Preterm Delivery, run by Obstetrix Medical Group at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Preterm Delivery
How many people: 995 participants
Where: 10 sitesUnited States
Study dates: Jul 2013to 25 Jul 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: All babies from singleton pregnancies delivering in each of the involved hospitals who delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
Harris Methodist Hospital - Fort Worth
Fort Worth, Texas, 76104
Saint Luke's Hospital, Kansas City
Kansas City, Missouri, 64111
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Banner Desert Medical Center
Mesa, Arizona, 85210
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Good Samaritan Hospital
San Jose, California, 95008
Scottsdale Healthcare-Shea Medical Center
Scottsdale, Arizona, 85260
Swedish Medical Center
Seattle, Washington, 98122-4307
Mercy Hospital of St. Louis
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study

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.

Read the 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).

Conditions: Preterm Delivery
Keywords: Preterm delivery, Premature delivery, Premature birth
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01818518
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201325 Jul 2016

First posted26 Mar 2013 (estimated)
Study startJul 2013
Primary completion3 May 2016
Study completion25 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Preterm DeliveryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 995 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01818518
Sponsor's protocol ID: OBX0022
Status last verified: Jun 2019
First submitted: 21 Mar 2013
Last updated: 18 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
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All Preterm Delivery trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
ClinicalTrials.gov ID: NCT01818518
Acronym / sponsor ID: OBX0022
Conditions: Preterm Delivery
Keywords: Preterm delivery, Premature delivery, Premature birth
Study type: Observational
Recruitment status: Completed
Enrolment: 995 participants (actual)
Lead sponsor: Obstetrix Medical GroupIndustry (pharma, biotech, devices)
Study start: Jul 2013 (actual)
Primary completion: 3 May 2016 (actual)
Study completion: 25 Jul 2016 (actual)
First posted: 26 Mar 2013 (estimated)
Results: Posted 7 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: All babies from singleton pregnancies delivering in each of the involved hospitals who delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.

Key inclusion criteria (7 listed)

Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating
Singleton pregnancy
Delivery where the baby is:
expires before it leaves the delivery room OR
is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Composite Perinatal Morbidity
Time frame: 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).

Results and safety

Results posted to the registry on 7 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prelabor Rupture of Membranes Diagnosis on Admission	310	310
Preterm Labor Diagnosis on Admission	263	263
Pre-eclampsia Diagnosis on Admission	288	288
Intrauterine Growth Restriction (IUGR) Diagnosis on Admission	59	59
Vaginal Bleeding Diagnosis on Admission	38	38
Short Cervix Diagnosis on Admission	37	37

Primary outcome: Composite Perinatal Morbidity

Time frame: Infants from birth until discharge or until infant reaches 28 days of life.. Number. Unit: participants

Measure	Prelabor Rupture of Membranes Diagnosis on Admission n = 310	Preterm Labor Diagnosis on Admission n = 263	Pre-eclampsia Diagnosis on Admission n = 288	IUGR Diagnosis on Admission n = 59	Vaginal Bleeding Diagnosis on Admission n = 38	Short Cervix Diagnosis on Admission n = 37
Composite Morbidity	277	203	221	45	28	33
Serious Morbidity	82	68	62	20	17	20
Perinatal (infant) Death	32	20	17	6	5	5
Respiratory distress syndrome (RDS)	206	190	211	43	23	27
On Ventilatory at 28 days of age	24	28	29	14	11	10
Intraventicular Hemorrhage Grade 3 or 4	13	19	8	1	5	8
Necrotizing Enterocolitis	9	15	14	3	5	2
Periventricular Leukomalacia (PVL)	2	1	1	1	1	0

Population analysed: 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.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Preterm Labor	0 of 0	0 of 0
Prelabor Rupture of Membranes	0 of 0	0 of 0
IUGR Diagnosis on Admission	0 of 0	0 of 0
Pre-Eclampsia Diagnosis on Admission	0 of 0	0 of 0
Vaginal Bleeding Diagnosis on Admission	0 of 0	0 of 0
Short Cervix Diagnosis on Admission	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. undecided

Related trials for Preterm Delivery

Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Garite, MD principal investigator

Obstetrix Medical Group

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Delivery, run by Obstetrix Medical Group at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Perinatal Morbidity (time frame: Infants from birth until discharge or until infant reaches 28 days of life.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01818518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.