A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab
NCT07915232, Not yet recruiting, Janssen Research & Development, LLC
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab | ClinicalTrials.gov |
| NCT number | NCT07915232 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 162 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Janssen Research & Development, LLC | ClinicalTrials.gov |
| Conditions | Pregnancy Related, Pregnancy, Pregnancy High-risk | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prevalence of Fetal Growth Restriction | During pregnancy (Up to Week 42) | A fetus with an estimated fetal weight less than the 10th percentile for gestational age based upon a population reference or standard. | ClinicalTrials.gov |
| Primary | Prevalence of Small for Gestational Age | At birth | A newborn with a birthweight less than the 10th percentile for gestational age based upon a population reference or standard. | ClinicalTrials.gov |
| Primary | Prevalence of Hypertensive Disorders of Pregnancy | From 20 weeks gestation through 6 weeks postpartum | Hypertensive disorder of pregnancy (that is, preeclampsia, gestational hypertension, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, or eclampsia). | ClinicalTrials.gov |
| Primary | Prevalence of Placental Abruption | During pregnancy (Up to Week 42) | A condition in which the placenta has begun to separate from the uterus before the fetus is born. | ClinicalTrials.gov |
| Primary | Prevalence of Serious Infections in Neonates | Birth to 27 days | Infections resulting in a hospitalization that occur within the first 27 days of life (0-27 days). | ClinicalTrials.gov |
| Primary | Prevalence of Serious Infections in Infants | 28 days to 365 days after birth | Infections resulting in a hospitalization that occur between 28 and 365 days of life. | ClinicalTrials.gov |
| Primary | Prevalence of Non-chromosomal Major Congenital Malformations | During pregnancy (up to Week 42) and up to 1 year after birth | Congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact, excluding those that are chromosomal or Mendelian-inherited anomalies. | ClinicalTrials.gov |
| Secondary | Prevalence of Live Birth | At Delivery | Delivery of a live newborn. | ClinicalTrials.gov |
| Secondary | Prevalence of Spontaneous Abortion | Prior to 20 weeks gestation | Clinically detected pregnancy loss before 20 completed weeks of gestation that occurs without medical or surgical intervention to terminate the pregnancy. | ClinicalTrials.gov |
| Secondary | Prevalence of Stillbirth | At or after 20 completed weeks of gestation | Fetus born dead at \>= 20 weeks gestation or weighing \>= 350 grams. Fetal death occurring \> 20 weeks but less than 28 weeks gestation is considered an early fetal loss. Fetal death occurring \> 28 weeks is considered a late fetal loss. If gestational age is unknown, stillbirth refers to a fetus weighing \>= 350 grams. | ClinicalTrials.gov |
| Secondary | Prevalence of Preterm Birth | Prior to 37 completed weeks of gestation | Delivery of a viable infant before 37 completed weeks of gestation. | ClinicalTrials.gov |
| Secondary | Prevalence of Intrapartum Hemorrhage | During pregnancy (Up to 42 weeks) | Maternal complication characterized by significant blood loss occurring during pregnancy. | ClinicalTrials.gov |
| Secondary | Prevalence of Postpartum Hemorrhage | At Birth and after 12 weeks delivery | Maternal complication characterized by significant blood loss occurring after pregnancy. | ClinicalTrials.gov |
| Secondary | Prevalence of Neonatal Death | Birth to 27 days | Death that occurs within the first 27 days of life (0-27 days). | ClinicalTrials.gov |
| Secondary | Prevalence of Infant Death | 28 days to 365 days after birth | Death that occurs between 28 and 365 days of life. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)