Trial · NCT03152058
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
NCT03152058, Phase 2, Recruiting, David Ware Branch
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy. Trials, record NCT03152058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03152058
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
- NCT number
- NCT03152058
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 55 participants, estimated
- Lead sponsor
- David Ware Branch
- Conditions
- High Risk Pregnancy, Pregnancy Complications, Antiphospholipid Syndrome in Pregnancy, Lupus Anticoagulant Disorder
- Interventions
- Certolizumab Pegol
- First posted
- 2017-05-12
- Last updated
- 2026-04-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fetal death and/or preterm delivery (<34 weeks) due to PE or PI in women with APS and LAC | 8 weeks gestation through 6-weeks postpartum | Either of the following will constitute a primary outcome: 1. Fetal death (\>10 wks gestation) 2. Severe preeclampsia or placental insufficiency requiring delivery prior to 34 weeks gestation. |
| Secondary | Additional adverse outcomes or pertinent concerns, possibly related to study intervention | 8 weeks gestation through 6-weeks postpartum | Any one of the following is considered a secondary outcome: 1. Neonatal death due to complications of prematurity because of preterm delivery for PE or PI 2. Preterm labor or preterm rupture of membranes resulting in delivery prior to 36 weeks gestation 3. PE or PI not requiring delivery prior to 34 weeks gestation 4. Gestational age at delivery 5. Maternal thrombosis 6. Small-for-gestational age birthweight (\<10th percentile) 7. Known adverse reactions to certolizumab. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers22
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 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.
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/NCT03152058
GET https://conductscience.org/api/trials/v1/NCT03152058/papers?page=2