Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02986802 · ClinicalTrials.gov registry record
Comparative Effectiveness of Treatment Options for Genital Herpes Infection to Reduce Adverse Pregnancy Outcomes
A clinical trial of Pregnancy Complications and Preterm Birth, sponsored by Kaiser Permanente.
- Completed
- Registry status
- 89,132
- Enrollment target
- 1
- Study location
NCT02986802: Completed study of Pregnancy Complications and Preterm Birth, sponsored by Kaiser Permanente.
NCT02986802 is a study of Pregnancy Complications and Preterm Birth that has completed, run by Kaiser Permanente. The registered enrollment target is 89,132 participants, above the 1,505-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (5822% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02986802, a study of Pregnancy Complications and Preterm Birth, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- 89,132 participants
- Enrollment target
- 1
- Study location
Study Summary
Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births with annual medical costs of more than $26 billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is considered a top research priority. Recent research has shown genital herpes infection (HSV) is associated with increased risks of PTD and LBW. More importantly, treating this infection, including infection with no symptoms, using readily available antiviral medications can be effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a lack of demonstrated benefit of treatment and (b) general hesitance to use medications during pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by anti-herpes medications has significantly changed current treatment paradigms among pregnant women. This evidence also provides new hope that effectively treating HSV infection among pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic disparities in these risks due to high rates of the infection in minority groups. To further examine the effectiveness of treating HSV in pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a prospective cohort study with a two-stage design combining the large pregnant women population (N=90,000) in Stage I identified through Kaiser Permanente Northern California (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed information on additional factors that might muddle our understanding of this issue. This study will address
Primary Outcome
Participants who gave birth before 37 completed weeks of gestation
Conditions Studied
Study Locations (1)
California
- Division of Research - Oakland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89,132 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2021-02-28 |
What the finished NCT02986802 record still lists
NCT02986802 is an observational study that tracks outcomes without assigning an intervention. Its 89,132 participants enrollment target places it among the larger protocols in the corpus, above the 1,505-participant average among 39 other Pregnancy Complications trials with a reported enrollment target (5822% higher).
The record links to 3 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 0 interventions.
NCT02986802 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02986802 about?
NCT02986802 is a clinical study titled "Comparative Effectiveness of Treatment Options for Genital Herpes Infection to Reduce Adverse Pregnancy Outcomes". Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births with annual medical costs of more than $26 billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is considered a top research priority. R...
What is the current status of trial NCT02986802?
This trial is currently completed. The enrollment target is 89,132 participants. The study started on 2017-03-14. Estimated completion is 2021-02-28.
What conditions does trial NCT02986802 study?
This clinical trial studies the following conditions: Pregnancy Complications, Preterm Birth, HSV-2 Infection.
Who is sponsoring clinical trial NCT02986802?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02986802 being conducted?
This trial has 1 study location across California. 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 NCT02986802's enrollment target sits among peer trials
89,132 1st of 39 higher than 39 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
- NCT05701111 · 80,800 participants · NA
Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress
- NCT00063063 · 80,000 participants
Generic Database of Very Low Birth Weight Infants
- NCT06625983 · 80,000 participants · NA
Use of a Colorectal Cancer Screening Decision Support Tool in Primary Care
- NCT01351545 · 99,999 participants
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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