Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi
Miscarriage, Stillbirth, Cholera
About this trial
This is an interventional prevention trial for Miscarriage focused on measuring Adverse pregnancy outcome
Eligibility Criteria
Inclusion criteria:
- Women aged 15-49 years old at time of consent (all cohorts)
- Urine sample provided if pregnancy test required (Not required if experienced delivery outcome between March 30 and enrollment date, OR visibly pregnant AND has due date indicated in Health Passport) (all cohorts)
- Received at least one dose of OCV in 2015 (must be verified with OCV Vaccination Card) (Cohorts 1 & 2)
- Estimated last menstruation at least 3 weeks before the first dose of OCV received (Nsanje) or before March 30, 2015 (Chikwawa) (Cohorts 1 & 3)
- Estimated last menstruation at least 2 weeks after the final dose of OCV received (Nsanje) or after the last day of OCV Round 2 (Chikwawa) (Cohorts 2 & 4)
- Residing in Nsanje or Chikwawa Districts since the first day of the vaccination campaign (30 March 2015) (Cohorts 2 & 3)
- Provides informed consent (with additional consent by the parent or legal guardian for unmarried <18 years old) (All Cohorts)
Exclusion criteria:
- Received at least one dose of OCV in 2015 (Cohorts 3 & 4)
- An otherwise eligible pregnant women who is unable to be contacted after the second attempt within 48 hours after the first attempt to enroll (All cohorts)
Sites / Locations
- Johns Hopkins Bloomberg School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
No Intervention
No Intervention
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 1: Women who were pregnant and received at least one dose of ShancholTM during the mass OCV vaccination campaign.
Cohort 2: Women who received at least one dose and who became pregnant after the mass vaccination campaign; hence their fetuses were not exposed to the vaccine.
Cohort 3: Women who were pregnant in Chikwawa District at the time of the vaccination campaign in Nsanje District, but who did not receive the vaccine during the campaign.
Cohort 4: Women who become pregnant in Chikwawa District after the vaccination campaign in Nsanje District, and who did not receive the vaccine during the campaign.