Trial · NCT00724594

Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)

NCT00724594, Phase 1, Phase 2, Completed, Medical University of South Carolina; results first posted 2015-04-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio). Trials, record NCT00724594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724594

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio)
NCT number: NCT00724594
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 46 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Chorioamnionitis, Brain Injury
Interventions: N-acetylcysteine, Control
First posted: 2008-07-29
Last updated: 2021-04-12
Results first posted: 2015-04-30

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	NAC Terminal Elimination Half-life	prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion
Primary	NAC Volume of Distribution	prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion
Primary	NAC Total Body Clearance	prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion
Primary	NAC Concentrations	Peak: 30 minutes after NAC infusion. Cord: at delivery
Primary	Placental Transfer Ratio	At time of delivery	Ratio of NAC concentration in cord to maternal venous blood
Primary	Maternal and Infant Mean Blood Pressure Change	Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing
Primary	Cerebral Blood Flow	after NAC infusion	Resistive index in middle cerebral artery (MCA)
Primary	Prothrombin Time	after N-acetylcystiene or saline infusion	prothrombin clotting time
Secondary	Magnetic Resonance Spectroscopy of Infants	36 - 40 weeks gestational age	ratio of myoInositol / NAA concentrations in basal ganglia
Secondary	Cytokine Level IL-1Ra in Plasma	after N-acetylcysteine infusion	anti-inflammatory cytokine Interleukin -1 Receptor alpha (IL-1Ra)

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	NAC Terminal Elimination Half-life	prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion		hours	MEAN
PRIMARY	NAC Volume of Distribution	prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion		L/kg	MEAN
PRIMARY	NAC Total Body Clearance	prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion		mL/h/kg	MEAN
PRIMARY	NAC Concentrations	Peak: 30 minutes after NAC infusion. Cord: at delivery		micromol/L	MEAN
PRIMARY	Placental Transfer Ratio	At time of delivery		ratio	MEAN
PRIMARY	Maternal and Infant Mean Blood Pressure Change	Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing	The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.	mmHg	MEAN
PRIMARY	Cerebral Blood Flow	after NAC infusion	blood flow resistive indices after first dose of N-acetylcysteine or saline	units on a scale	MEAN
PRIMARY	Prothrombin Time	after N-acetylcystiene or saline infusion		seconds	MEAN
SECONDARY	Magnetic Resonance Spectroscopy of Infants	36 - 40 weeks gestational age		ratio	MEAN
SECONDARY	Cytokine Level IL-1Ra in Plasma	after N-acetylcysteine infusion		pg/ml	MEDIAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
NAC Terminal Elimination Half-life	NAC Maternal		1.2	Standard Deviation 0.2	hours
NAC Terminal Elimination Half-life	NAC Preterm Infants		7.5	Standard Deviation 2.0	hours
NAC Terminal Elimination Half-life	NAC Term Infants		5.1	Standard Deviation 1.3	hours
NAC Volume of Distribution	NAC Maternal		0.41	Standard Deviation 0.07	L/kg
NAC Volume of Distribution	NAC Preterm Infants		0.47	Standard Deviation 0.04	L/kg
NAC Volume of Distribution	NAC Term Infants		0.38	Standard Deviation 0.09	L/kg
NAC Total Body Clearance	NAC Maternal		255	Standard Deviation 61	mL/h/kg
NAC Total Body Clearance	NAC Preterm Infants		45.0	Standard Deviation 8.2	mL/h/kg
NAC Total Body Clearance	NAC Term Infants		53.7	Standard Deviation 11.3	mL/h/kg
NAC Concentrations	NAC Maternal	Peak NAC concentration in plasma	1222	Standard Deviation 415	micromol/L

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NAC Infant	12
Overall Study	STARTED	Control Infant	12
Overall Study	STARTED	NAC Maternal	11
Overall Study	STARTED	Control Maternal	11
Overall Study	COMPLETED	NAC Infant	12
Overall Study	COMPLETED	Control Infant	12
Overall Study	COMPLETED	NAC Maternal	11
Overall Study	COMPLETED	Control Maternal	10
Overall Study	NOT COMPLETED	NAC Infant	0
Overall Study	NOT COMPLETED	Control Infant	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rash/Hives	Skin and subcutaneous tissue disorders	NAC Infant	0	12	0
other	Rash/Hives	Skin and subcutaneous tissue disorders	Control Infant	0	12	0
other	Rash/Hives	Skin and subcutaneous tissue disorders	NAC Maternal	1	11	1
other	Rash/Hives	Skin and subcutaneous tissue disorders	Control Maternal	0	11	0
other	Shortness of breath/wheezing	Respiratory, thoracic and mediastinal disorders	NAC Infant	0	12	0
other	Shortness of breath/wheezing	Respiratory, thoracic and mediastinal disorders	Control Infant	0	12	0
other	Shortness of breath/wheezing	Respiratory, thoracic and mediastinal disorders	NAC Maternal	0	11	0
other	Shortness of breath/wheezing	Respiratory, thoracic and mediastinal disorders	Control Maternal	1	11	1
other	Hypotension	Blood and lymphatic system disorders	NAC Infant	0	12	0
other	Hypotension	Blood and lymphatic system disorders	Control Infant	1	12	1

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NAC Infant
Total, all-cause mortality	Control Infant
Total, all-cause mortality	NAC Maternal
Total, all-cause mortality	Control Maternal
Total, other adverse events	NAC Infant	5	12
Total, other adverse events	Control Infant	3	12
Total, other adverse events	NAC Maternal	2	11
Total, other adverse events	Control Maternal	2	11
Total, serious adverse events	NAC Infant	4	12
Total, serious adverse events	Control Infant	3	12

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25064164	RESULT	PubMed
26545726	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01NS052448	Safety of N-acetylcysteine in Maternal Chorioamnionitis	JENKINS, DOROTHEA DENISE	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2007 to 2009

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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