Trial Outcomes & Findings for Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania (NCT NCT04325542)
NCT ID: NCT04325542
Last Updated: 2020-10-26
Results Overview
Number of women attending antenatal clinic at the Bugando Medical Center in Mwanza, Tanzania with Hepatitis B surface antigen (HBsAg) rapid test positive result.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
743 participants
Primary outcome timeframe
Day 1
Results posted on
2020-10-26
Participant Flow
Participant milestones
| Measure |
HBSAG Positive With Rapid Test
Newborns from woman who are positive with HBSAG rapid test got WHO recommended HBV vaccination at birth to avoid HBV transmission
HBSAg (sure screen test): Diagnostic test for Hepatitis B
|
|---|---|
|
Overall Study
STARTED
|
743
|
|
Overall Study
COMPLETED
|
742
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania
Baseline characteristics by cohort
| Measure |
HBSAG Positive With Rapid Test
n=742 Participants
Newborns from woman who are positive with HBSAG rapid test got WHO recommended HBV vaccination at birth to avoid HBV transmission
HBSAg (sure screen test): Diagnostic test for Hepatitis B
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
742 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
26 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
742 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Tanzania
|
742 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 1Number of women attending antenatal clinic at the Bugando Medical Center in Mwanza, Tanzania with Hepatitis B surface antigen (HBsAg) rapid test positive result.
Outcome measures
| Measure |
HBSAG Positive With Rapid Test
n=743 Participants
Number of women attending antenatal clinic at the Bugando Medical Center in Mwanza, Tanzania with Hepatitis B surface antigen (HBsAg) rapid test positive result.
HBSAg (sure screen test): Diagnostic test for Hepatitis B
|
|---|---|
|
HBsAG Prevalence
|
22 Participants
|
Adverse Events
HBSAG Positive With Rapid Test
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place