Trial · NCT00201643
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
NCT00201643, Phase 4, Completed, Obstetrix Medical Group; results first posted 2011-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome. Trials, record NCT00201643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00201643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
- NCT number
- NCT00201643
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 437 participants, actual
- Lead sponsor
- Obstetrix Medical Group
- Conditions
- Preterm Delivery
- Interventions
- Betamethasone or Dexamethasone (2nd course of ACS), Placebo
- First posted
- 2005-09-20
- Last updated
- 2015-01-07
- Results first posted
- 2011-03-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | From birth to 28 days of life | This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death |
| Secondary | Gestational Age at (@) Delivery | gestational age at delivery in weeks of gestation | Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo). |
| Secondary | Neonatal Birth Weight Reported in Grams | At time of Birth | Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record. |
| Secondary | Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. | Measured at birth. | Noted as the total number of Neonates delivering at \< 34 weeks gestation for which their weights fell within the 10th percentile at time of birth. |
| Secondary | Neonatal Head Circumference Taken at Time of Birth. | Birth | Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group. |
| Secondary | Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life. | birth to 28 days of life | The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day. |
| Secondary | Number of Neonates Who Required Surfactant Therapy After Birth. | Birth to 28 days of life | The Number of neonates who required surfactant therapy within the first 28 days after birth. |
| Secondary | Number of Neonates With Pneumothorax | birth to 28 days of life | Total number of neonates with pneumothorax diagnosed postpartum. |
| Secondary | Maternal Infectious Morbidity. | Up to 28 days after giving birth | Total number of Mothers having Maternal infectious morbidity (e.g. endometritis \& maternal sepsis) noted from birth through 28 days after birth |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | From birth to 28 days of life | This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%). | participants | NUMBER |
| SECONDARY | Gestational Age at (@) Delivery | gestational age at delivery in weeks of gestation | Modified intent to treat | Weeks | MEAN |
| SECONDARY | Neonatal Birth Weight Reported in Grams | At time of Birth | Intent to treat protocol | grams | MEAN |
| SECONDARY | Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. | Measured at birth. | Intent to Treat | paticipants | NUMBER |
| SECONDARY | Neonatal Head Circumference Taken at Time of Birth. | Birth | Intent to treat | centemeters (cm) | MEAN |
| SECONDARY | Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life. | birth to 28 days of life | Intent to treat (ITT) | participants | NUMBER |
| SECONDARY | Number of Neonates Who Required Surfactant Therapy After Birth. | Birth to 28 days of life | ITT | participant | NUMBER |
| SECONDARY | Number of Neonates With Pneumothorax | birth to 28 days of life | ITT | participants | NUMBER |
| SECONDARY | Maternal Infectious Morbidity. | Up to 28 days after giving birth | ITT | participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | Rescue Course of Betamethasone or Dexamethasone | 71 | participants | ||
| Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | Placebo (Normal Saline) | 105 | participants | ||
| Gestational Age at (@) Delivery | Rescue Course of Betamethasone or Dexamethasone | 33.1 | Standard Deviation 3.1 | Weeks | |
| Gestational Age at (@) Delivery | Placebo (Normal Saline) | 33.0 | Standard Deviation 3.1 | Weeks | |
| Neonatal Birth Weight Reported in Grams | Rescue Course of Betamethasone or Dexamethasone | 1905 | Standard Deviation 738 | grams | |
| Neonatal Birth Weight Reported in Grams | Placebo (Normal Saline) | 1920 | Standard Deviation 667 | grams | |
| Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. | Rescue Course of Betamethasone or Dexamethasone | 25 | paticipants | ||
| Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. | Placebo (Normal Saline) | 20 | paticipants | ||
| Neonatal Head Circumference Taken at Time of Birth. | Rescue Course of Betamethasone or Dexamethasone | 30.2 | Standard Deviation 3.0 | centemeters (cm) | |
| Neonatal Head Circumference Taken at Time of Birth. | Placebo (Normal Saline) | 30.0 | Standard Deviation 2.9 | centemeters (cm) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rescue Course of Betamethasone or Dexamethasone | 223 | |
| Overall Study | STARTED | Placebo (Normal Saline) | 214 | |
| Overall Study | COMPLETED | Rescue Course of Betamethasone or Dexamethasone | 218 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) | 210 | |
| Overall Study | NOT COMPLETED | Rescue Course of Betamethasone or Dexamethasone | 5 | |
| Overall Study | NOT COMPLETED | Placebo (Normal Saline) | 4 |
Source ClinicalTrials.gov
Adverse events52
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 |
|---|---|---|---|---|---|---|
| serious | Anemia | Blood and lymphatic system disorders | Rescue Course of Betamethasone or Dexamethasone | 2 | 512 | 2 |
| serious | Anemia | Blood and lymphatic system disorders | Placebo (Normal Saline) | 1 | 502 | 1 |
| serious | Congenital Defect | Congenital, familial and genetic disorders | Rescue Course of Betamethasone or Dexamethasone | 8 | 289 | 10 |
| serious | Congenital Defect | Congenital, familial and genetic disorders | Placebo (Normal Saline) | 12 | 288 | 13 |
| serious | DIC | Blood and lymphatic system disorders | Rescue Course of Betamethasone or Dexamethasone | 0 | 512 | 0 |
| serious | DIC | Blood and lymphatic system disorders | Placebo (Normal Saline) | 1 | 502 | 1 |
| serious | Aortic Stenosis | Cardiac disorders | Rescue Course of Betamethasone or Dexamethasone | 1 | 289 | 1 |
| serious | Aortic Stenosis | Cardiac disorders | Placebo (Normal Saline) | 1 | 288 | 1 |
| serious | Cardiac Dysfunction | Cardiac disorders | Rescue Course of Betamethasone or Dexamethasone | 5 | 289 | 5 |
| serious | Cardiac Dysfunction | Cardiac disorders | Placebo (Normal Saline) | 2 | 288 | 2 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rescue Course of Betamethasone or Dexamethasone | ||
| Total, all-cause mortality | Placebo (Normal Saline) | ||
| Total, other adverse events | Rescue Course of Betamethasone or Dexamethasone | 0 | 512 |
| Total, other adverse events | Placebo (Normal Saline) | 0 | 502 |
| Total, serious adverse events | Rescue Course of Betamethasone or Dexamethasone | 40 | 512 |
| Total, serious adverse events | Placebo (Normal Saline) | 41 | 502 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life. | Trial comparisons |
| Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): Number of Neonates With Pneumothorax | Trial comparisons |
| Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. | Trial comparisons |
| Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): Maternal Infectious Morbidity. | Trial comparisons |
| Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00201643
GET https://conductscience.org/api/trials/v1/NCT00201643/events?page=2