Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03152058 · ClinicalTrials.gov registry record · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
A Phase 2 study of Pregnancy Complications and High Risk Pregnancy, sponsored by David Ware Branch.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 3
- Study locations
NCT03152058: Recruiting Phase 2 study of Pregnancy Complications and High Risk Pregnancy, sponsored by David Ware Branch.
NCT03152058 is a Phase 2 study of Pregnancy Complications and High Risk Pregnancy that is actively recruiting participants, run by David Ware Branch. The registered enrollment target is 55 participants, below the 3,789-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03152058, a Phase 2 study of Pregnancy Complications and High Risk Pregnancy, is actively recruiting participants, sponsored by David Ware Branch.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 3
- Study locations
Study Summary
This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Certolizumab Pegol
Study Locations (3)
New York
- Hospital for Special Surgery - New York
Utah
- University of Utah - Salt Lake City
Ontario
- TRIO Advancing Reproductive Care - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT03152058 shows while recruiting
NCT03152058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 3,789-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 1 intervention - of which Certolizumab Pegol is the first listed.
NCT03152058 reports a single indexed study location in New York, Utah, Ontario.
Frequently Asked Questions
What is clinical trial NCT03152058 about?
NCT03152058 is a clinical study titled "IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy". This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this reg...
What is the current status of trial NCT03152058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2017-05-17. Estimated completion is 2026-12.
What conditions does trial NCT03152058 study?
This clinical trial studies the following conditions: Pregnancy Complications, High Risk Pregnancy, Antiphospholipid Syndrome in Pregnancy, Lupus Anticoagulant Disorder.
What interventions are being tested in trial NCT03152058?
The interventions under investigation include: Certolizumab Pegol (DRUG).
Who is sponsoring clinical trial NCT03152058?
This trial is sponsored by David Ware Branch, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03152058 being conducted?
This trial has 3 study locations across New York, Utah, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03152058's enrollment target sits among peer trials
55 32nd of 39 higher than 8 of 39 other Pregnancy Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
RECRUITING · Phase 2
-
Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes
RECRUITING · Phase 2
-
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
RECRUITING · NA
-
Treatment With Aspirin After Preeclampsia: TAP Trial
RECRUITING · Phase 4
-
Delivering HOPE (Helping Women Optimize Prenatal Equity)
RECRUITING · NA
-
Better Lifestyle Counseling for African American Women During Pregnancy
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03317158 · 55 participants · Phase 1
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI