Trial · NCT01494038
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment | Measured from study entry through Week 48 after birth | Incidence rate, calculated by Mantel-Haenszel (MH), weighted by gestational age strata 1) gestational age at entry less than 24 weeks or 2) gestational age at entry greater than or equal to 24 weeks. AE's include laboratory results, signs/symptoms, or diagnoses; graded as per Division of AIDS (DAIDS) or by protocol-defined hepatotoxicity measures. Related to treatment indicates possibly, probably, or definitely related to INH or Placebo for INH as judged by Independent Endpoint Review Committee. Discontinuation refers to permanent discontinuation of study treatment. |
| Secondary | Number of Mothers With a Fetal Death | Measured from study entry through end of pregnancy | Fetal deaths include both stillbirths and spontaneous abortions; in case of a multiple birth, mothers who had at least one fetal death |
| Secondary | Number of Mothers With a Fetus Small for Gestational Age | Measured at delivery | Small for gestational age was determined by physician at site |
| Secondary | Number of Mothers With an Infant Born Prematurely | Measured at delivery | Premature birth is defined as gestational age of \< 37 weeks at delivery. |
| Secondary | Number of Mothers With a Low Birth-weight Infant | Measured on day of birth | Low birth weight is defined as weight \< 2500 mg |
| Secondary | Number of Mothers With an Infant With a Congenital Anomaly | Measured from study entry through Week 48 after birth | Includes congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria. |
| Secondary | Number of Mothers With an Adverse Pregnancy Outcome: Spontaneous Abortion, Stillbirth, Premature Birth, Low Birth Weight, or Congenital Anomaly | Measured from study entry through Week 48 after birth | In case of a multiple birth, mothers who had at least one adverse pregnancy outcome. Spontaneous abortion is intra-uterine fetal death prior to 20 weeks of gestational age; stillbirth, the same, \>= 20 weeks; preterm delivery, \< 37 weeks of gestational age; low birth weight, \< 2,500 grams, and congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria. |
| Secondary | Number of Infants With Grade 3 or Higher Clinical or Laboratory AE | Measured from study entry through Week 48 after birth | Laboratory, sign/symptom, or diagnoses graded as 3 or higher by DAIDS criteria. |
| Secondary | Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment | Measured from study entry through Week 48 after birth | As before, but AE is judged to be possibly, probably, or definitely related to INH or Placebo for INH, by clinic medical staff |
| Secondary | Number of Infants Which Are HIV-infected | Measured from study entry through study Week 44 | HIV infection determined during follow-up period. Infection at birth or during breastfeeding |
| Secondary | Number of Infants Hospitalized | Measured from study entry through Week 48 after birth | Hospitalization due to reasons other than birth |
| Secondary | Incidence Rate of TB Infection Among Mothers | Measured from study entry to Week 48 after birth | Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB infection, as judged by Secondary Endpoint Review Committee |
| Secondary | Incidence Rate of Tuberculosis (TB) Among Infants | Measured from study entry through Week 48 after birth | Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB, or congenital TB as defined using the Cantwell criteria (see reference), judged by the Secondary Endpoint Review Committee. Includes an infant death due to unknown cause. |
| Secondary | Incidence Rate of Infant Death | Measured from study entry through Week 48 after birth | Incidence rate was calculated by Mantel-Haenszel, weighted by gestational age strata. |
| Secondary | Incidence Rate of Maternal Deaths | Measured from study entry through Week 48 postpartum | Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. |
| Secondary | Incidence Rate of Combined Endpoints: Maternal TB or Maternal Death | Measured from study entry through Week 48 after birth | Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. |
| Secondary | Incidence Rate of Combined Endpoints: Infant TB or Infant Death | Measured from study entry through Week 48 after birth | Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. |
| Secondary | Incidence Rate of Combined Endpoints: Maternal TB, Maternal Death, Infant TB, or Infant Death | Measured from study entry through Week 48 after birth | Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. |
| Secondary | Incidence Rate of Combined Endpoint, Antepartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE | Measured from study entry through end of pregnancy | Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata |
| Secondary | Incidence Rate of Combined Endpoint, up to 12 Weeks Postpartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE | Measured from study entry through 12 weeks after birth | Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT01494038/registered