Reduction of low birth weight at delivery through the adjunction of oral azithromycin to the intermittent preventive treatment of malaria in pregnant women: a randomized controlled trial in rural Burkina Faso

Phase 4

Recruiting

• Conditions: Malaria; Neonatal Diseases; Pregnancy and Childbirth

• Registration Number: PACTR201808177464681
• Lead Sponsor: clinical research unit of nanoro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 942

Inclusion Criteria

1. Being a pregnant woman between 16 and 32 weeks of pregnancy
2. At least 15 years old; and under 44 years old
3. Residence within the health facility catchment’s area,
4. Willingness to deliver at the health facility;
5. Willingness to adhere to the study protocol requirements;
6. Ability to provide written informed consent.

Exclusion Criteria

1. History of allergic reactions to the study drugs;
2. History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
3. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
4. Multiple pregnancies (i.e. twin/triplets);
5. Current cotrimoxazole prophylaxis or anti-retroviral therapy (ART);
6. Any significant ongoing condition that requires hospitalization, including severe malaria;
7. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area;
8. Prior enrollment in the study or concurrent enrollment in another study;
9. Unable to take oral medication;
10. Clear evidence of recent treatment with artemisinin based combination treatment (ACT), SP or azithromycin during the first trimester of pregnancy, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified