Trial · NCT05912517
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death | From randomization in the study through 4 weeks of age or 41 weeks Postmenstrual Age (PMA) during neonatal period, whichever is later | Percentage of pregnancies that did not result in fetal loss, IUT, hydrops fetalis, or neonatal death (during the neonatal period) will be reported. Hydrops fetalis is defined as the presence of greater than or equal to(\>=)2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater (\>)5 millimeter \[mm\]). PMA is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age). |
| Secondary | Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity | For first database lock: from randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later for the first database lock; for second database lock: through 12 weeks after birth | Number of participants with HDFN by severity will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. Here database lock implies the last participant has given birth or terminated their pregnancy, completed the Week 4 visit after delivery, and whose neonate has also completed the Week 4 visit (or 41 weeks PMA, whichever is later) or died prior to this timepoint. |
| Secondary | Time to First Occurrence of IUT or Hydrops Fetalis | From randomization to delivery of baby (Up to 38 weeks) | Time to first occurrence of IUT or hydrops fetalis will be reported. |
| Secondary | Neonatal Mortality and Morbidity Index (NMMI) in Liveborn Neonates | Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA | The NMMI will be assessed with the following categories: fatal: fetal/neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category' |
| Secondary | Number of IUT's Received During the Pregnancy | From randomization to delivery of baby (Up to 38 weeks) | Number of IUT's received during the pregnancy will be reported. |
| Secondary | Percentage of Pregnancies With Fetal Loss | Time to delivery of baby (Up to 38 weeks) | Percentage of pregnancies with fetal loss will be reported. |
| Secondary | Percentage of Pregnancies With Fetal or Neonatal Death | Through Week 4 or 41 weeks PMA | Percentage of pregnancies with fetal or neonatal death (through the neonatal period) as a result of HDFN will be reported. |
| Secondary | Percentage of Pregnancies With Hydrops Fetalis | Up to 41 weeks PMA | Percentage of pregnancies with hydrops fetalis will be reported. Hydrops fetalis is defined as the presence of \>=2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness \>5 mm). |
| Secondary | Percentage of Pregnancies Receiving IUT During Pregnancy | Up to 35 weeks of GA period | Percentage of pregnancies receiving IUT during pregnancy will be reported. |
| Secondary | Gestational Age (GA) at First IUT | Up to 35 weeks of GA period | GA at first IUT will be reported. |
| Secondary | Percentage of Pregnancies Receiving >1 IUT During Pregnancy | Up to 35 weeks of GA period | Percentage of pregnancies receiving \>1 IUT during pregnancy will be reported. |
| Secondary | Percentage of Pregnancies Receiving IUT or HDFN Resulting in Fetal Demise (Less Than) <GA Week 20 | Up to 20 weeks | Percentage of pregnancies receiving IUT or HDFN resulting in fetal demise \<GA Week 20 will be reported. |
| Secondary | Gestational Age at Delivery | Up to 38 weeks | Gestational age at delivery will be reported. |
| Secondary | Percentage of Pregnancies With Neonatal Death Through the Neonatal Period | From randomization in the study through 4 weeks of age or 41 weeks PMA during neonatal period, whichever is later | Percentage of pregnancies with neonatal death through the neonatal period will be reported. |
| Secondary | Percentage of Liveborn Neonates With HDFN-related Morbidities Other Than Anemia and Hyperbilirubinemia or Jaundice | From day of birth up to 4 weeks | Percentage of liveborn neonates with HDFN-related morbidities other than anemia and hyperbilirubinemia or jaundice will be reported. |
| Secondary | Absolute Weight of Liveborn Neonates or Infants | Up to 104 weeks | Absolute weight of liveborn neonates or infants will be reported. |
| Secondary | Change From Baseline in Weight of Liveborn Neonates or Infants | Baseline to up to 104 weeks | Change from baseline in weight of liveborn neonates or infants will be reported. |
| Secondary | Liveborn Neonates Length of Stay in Neonatal Intensive Care Unit | From day of birth up to 27 days | Liveborn neonates length of stay in neonatal intensive care unit will be reported. |
| Secondary | Percentage of Liveborn Neonates Receiving Exchange Transfusions for HDFN | From day of birth up to 27 days | Percentage of liveborn neonates receiving exchange transfusions for HDFN will be reported. |
| Secondary | Number of Neonatal Exchange Transfusions per Liveborn Neonate | From day of birth up to 27 days | Number of neonatal exchange transfusions per liveborn neonate will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05912517/registered