This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Severe maternal morbidity, or SMM, refers to unexpected outcomes of labor and delivery that pose serious risks to the mother and baby. SMM includes health problems such as heart failure, sepsis, and blood clots. Black women are at increased risk of SMM compared with White women.
Pregnant women with genital herpes have an increased risk of SMM. Medicine may help reduce this risk. Because Black women have a higher rate of genital herpes infection than White women, treating herpes infections during pregnancy may also help reduce racial disparities in SMM.
In this study, the research team is looking to see if treating herpes infection during pregnancy helps reduce disparities in SMM between Black and White women. The team also wants to know if starting treatment for herpes infection earlier is more effective at reducing racial disparities in SMM than treating infection during the third trimester. Current guidelines recommend treating herpes in the third trimester to prevent the baby from becoming infected. But this timing may be too late to prevent SMM.
Who can this research help?
Results may help doctors and patients when deciding on the best time to treat herpes in pregnancy.
What is the research team doing?
The research team is using clinical data from electronic health records, or EHRs, for 339,000 pregnant women. Based on whether women have herpes and whether they received treatment, the team is creating four groups:
- Women with herpes who received treatment before the third trimester
- Women with herpes who received treatment during the third trimester
- Women with herpes who didn’t receive treatment during pregnancy
- Women without herpes
Next, the research team is comparing rates of SMM across these groups. The team is also comparing rates of SMM between Black and White women.
Lastly, the research team is selecting a group of 1,200 women from the four groups by chance to take part in interviews. The team wants to learn more about risk factors that could affect SMM, such as whether women had a past pregnancy. The team is looking to see how these risk factors affect study results.
Patients who have had herpes during pregnancy, doctors, and advocacy groups are helping to plan and conduct this study.
Research methods at a glance
|Design||Observational: cohort study|
|Population||339,000 pregnant women who are members of Kaiser Permanente of Northern California|
Primary: SMM (based on the Centers for Disease Control and Prevention’s 21 indicators)
|Timeframe||Immediate follow-up after delivery for primary outcome|