Trial Outcomes & Findings for Comparative Effectiveness of Treatment Options for Genital Herpes Infection to Reduce Adverse Pregnancy Outcomes (NCT NCT02986802)
NCT ID: NCT02986802
Last Updated: 2021-09-17
Results Overview
Participants who gave birth before 37 completed weeks of gestation
Recruitment status
COMPLETED
Target enrollment
89132 participants
Primary outcome timeframe
Up to 37 weeks
Results posted on
2021-09-17
Participant Flow
Participant milestones
| Measure |
Genital Herpes Treated Before Third Trimester
Women with genital herpes receiving treatment before the 3rd trimester
|
Genital Herpes Treated Only During Third Trimester
Women with genital herpes receiving treatment during the 3rd trimester
|
Genital Herpes Untreated
Women with untreated genital herpes
|
Control Group
Women (controls) with neither genital herpes nor treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1360
|
2839
|
1873
|
83060
|
|
Overall Study
COMPLETED
|
1360
|
2839
|
1873
|
83060
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Women who were missing parity data are not included.
Baseline characteristics by cohort
| Measure |
Genital Herpes Treated Before Third Trimester
n=1360 Participants
Women with genital herpes receiving treatment before the 3rd trimester
|
Genital Herpes Treated Only During Third Trimester
n=2839 Participants
Women with genital herpes receiving treatment during the 3rd trimester
|
Genital Herpes Untreated
n=1873 Participants
Women with untreated genital herpes
|
Control Group
n=83060 Participants
Women (controls) with neither genital herpes nor treatment
|
Total
n=89132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age (years) · 18-24
|
149 Participants
n=1360 Participants
|
250 Participants
n=2839 Participants
|
152 Participants
n=1873 Participants
|
9170 Participants
n=83060 Participants
|
9721 Participants
n=89132 Participants
|
|
Age, Customized
Age (years) · 25-29
|
278 Participants
n=1360 Participants
|
625 Participants
n=2839 Participants
|
399 Participants
n=1873 Participants
|
21155 Participants
n=83060 Participants
|
22457 Participants
n=89132 Participants
|
|
Age, Customized
Age (years) · 30-34
|
431 Participants
n=1360 Participants
|
986 Participants
n=2839 Participants
|
595 Participants
n=1873 Participants
|
30900 Participants
n=83060 Participants
|
32912 Participants
n=89132 Participants
|
|
Age, Customized
Age (years) · ≥35
|
502 Participants
n=1360 Participants
|
978 Participants
n=2839 Participants
|
727 Participants
n=1873 Participants
|
21835 Participants
n=83060 Participants
|
24042 Participants
n=89132 Participants
|
|
Sex: Female, Male
Female
|
1360 Participants
n=1360 Participants
|
2839 Participants
n=2839 Participants
|
1873 Participants
n=1873 Participants
|
83060 Participants
n=83060 Participants
|
89132 Participants
n=89132 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1360 Participants
|
0 Participants
n=2839 Participants
|
0 Participants
n=1873 Participants
|
0 Participants
n=83060 Participants
|
0 Participants
n=89132 Participants
|
|
Race/Ethnicity, Customized
White
|
633 Participants
n=1360 Participants
|
1338 Participants
n=2839 Participants
|
758 Participants
n=1873 Participants
|
28887 Participants
n=83060 Participants
|
31616 Participants
n=89132 Participants
|
|
Race/Ethnicity, Customized
Asian
|
116 Participants
n=1360 Participants
|
331 Participants
n=2839 Participants
|
232 Participants
n=1873 Participants
|
22591 Participants
n=83060 Participants
|
23270 Participants
n=89132 Participants
|
|
Race/Ethnicity, Customized
African American
|
217 Participants
n=1360 Participants
|
381 Participants
n=2839 Participants
|
299 Participants
n=1873 Participants
|
4660 Participants
n=83060 Participants
|
5557 Participants
n=89132 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
302 Participants
n=1360 Participants
|
615 Participants
n=2839 Participants
|
460 Participants
n=1873 Participants
|
22026 Participants
n=83060 Participants
|
23403 Participants
n=89132 Participants
|
|
Race/Ethnicity, Customized
Other/multiple/unknown
|
92 Participants
n=1360 Participants
|
174 Participants
n=2839 Participants
|
124 Participants
n=1873 Participants
|
4896 Participants
n=83060 Participants
|
5286 Participants
n=89132 Participants
|
|
Region of Enrollment
United States
|
1360 participants
n=1360 Participants
|
2839 participants
n=2839 Participants
|
1873 participants
n=1873 Participants
|
83060 participants
n=83060 Participants
|
89132 participants
n=89132 Participants
|
|
Parity
0
|
639 Participants
n=1345 Participants • Women who were missing parity data are not included.
|
1249 Participants
n=2798 Participants • Women who were missing parity data are not included.
|
664 Participants
n=1808 Participants • Women who were missing parity data are not included.
|
38369 Participants
n=82257 Participants • Women who were missing parity data are not included.
|
40921 Participants
n=88208 Participants • Women who were missing parity data are not included.
|
|
Parity
1
|
428 Participants
n=1345 Participants • Women who were missing parity data are not included.
|
954 Participants
n=2798 Participants • Women who were missing parity data are not included.
|
659 Participants
n=1808 Participants • Women who were missing parity data are not included.
|
27965 Participants
n=82257 Participants • Women who were missing parity data are not included.
|
30006 Participants
n=88208 Participants • Women who were missing parity data are not included.
|
|
Parity
2 or more
|
278 Participants
n=1345 Participants • Women who were missing parity data are not included.
|
595 Participants
n=2798 Participants • Women who were missing parity data are not included.
|
485 Participants
n=1808 Participants • Women who were missing parity data are not included.
|
15923 Participants
n=82257 Participants • Women who were missing parity data are not included.
|
17281 Participants
n=88208 Participants • Women who were missing parity data are not included.
|
PRIMARY outcome
Timeframe: Up to 37 weeksPopulation: Women who could not be classified into any of the designed Arms/Groups as listed due to their starting treatment too late for examining preterm delivery (\< 37 weeks of gestation) were considered as ineligible and therefore excluded from the analyses related to preterm delivery. They did not contribute to the results or conclusions related to preterm delivery.
Participants who gave birth before 37 completed weeks of gestation
Outcome measures
| Measure |
Genital Herpes Treated Before Third Trimester
n=1360 Participants
Women with genital herpes receiving treatment before the 3rd trimester
|
Genital Herpes Treated Only During Third Trimester
n=1411 Participants
Women with genital herpes receiving treatment during the 3rd trimester
|
Genital Herpes Untreated
n=1873 Participants
Women with untreated genital herpes
|
Control Group
n=83060 Participants
Women (controls) with neither genital herpes nor treatment
|
|---|---|---|---|---|
|
Number of Participants With Preterm Delivery
Preterm
|
100 Participants
|
83 Participants
|
247 Participants
|
5407 Participants
|
|
Number of Participants With Preterm Delivery
Not Preterm
|
1260 Participants
|
1328 Participants
|
1626 Participants
|
77653 Participants
|
PRIMARY outcome
Timeframe: Through the end of pregnancy, an average of 40 weeksPopulation: Participants with birth weight data were included.
Women having a child born with birthweight \<2500 grams
Outcome measures
| Measure |
Genital Herpes Treated Before Third Trimester
n=1353 Participants
Women with genital herpes receiving treatment before the 3rd trimester
|
Genital Herpes Treated Only During Third Trimester
n=2829 Participants
Women with genital herpes receiving treatment during the 3rd trimester
|
Genital Herpes Untreated
n=1845 Participants
Women with untreated genital herpes
|
Control Group
n=83052 Participants
Women (controls) with neither genital herpes nor treatment
|
|---|---|---|---|---|
|
Number of Participants With a Low Birthweight Child
Low Birth Weight
|
66 Participants
|
59 Participants
|
153 Participants
|
4068 Participants
|
|
Number of Participants With a Low Birthweight Child
Not Low Birth Weight
|
1287 Participants
|
2770 Participants
|
1692 Participants
|
78984 Participants
|
Adverse Events
Genital Herpes Treated Before Third Trimester
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genital Herpes Treated Only During Third Trimester
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genital Herpes Untreated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
De-Kun Li, MD, PhD
Kaiser Permanente Division of Research
Phone: 510.891.3755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place