Nutritional, Metabolic, Endocrine Pregnancy and Childbirth
Conditions
Sponsors
WHC WITS HEALTH CONSORTIUM PTY LTD
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Healthy pregnant women aged = 18 and =45 years of age, including pregnant women living with HIV (PWLHIV). • PWLHIV will be eligible irrespective of disease control, treatment regimen or treatment duration. • Pregnant women = 14 and = 32 weeks gestational age (GA) to allow for a reasonable period of follow-up and birth outcome collection, as determined by study GA definition. • Attending ANC at any of the participating Region F primary health care facilities. • Fluent in the population widely-spoken local language in which the interview can be conducted (English, IsiZulu, SeSotho). • Ability to read write and understand study document language (as above). Illiterate women will not be excluded, family member/friend can be enlisted to assist with study document completion. • Willing and able to provide written informed consent as well as understand ICFs
Exclusion criteria
Exclusion criteria: • History of adverse reaction to any of the study product ingredients. • Presence of pregnancy-related complications or abnormalities at the time of consent that, in the opinion of the study nurse/investigator, may increase the risk associated with study participation or completion, including but not limited to uncontrolled comorbidities as per participant report and maternal case report review. • Currently diagnosed with any micronutrient deficiency, requiring further participant-based management. • Taking any of the prohibited medication listed in Section 10.1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability;Adherence | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative Insights;Birth outcomes - Descriptive data on birth outcomes, and maternal wellbeing, consistent with international MMS studies. | — |
Countries
South Africa
Contacts
Public ContactLisa;Elizea Mills;Horne
Project Manager;Principal Investigator
Outcome results
None listed