PACTR201808177464681
Recruiting
Phase 4
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
clinical research unit of nanoro0 sites942 target enrollmentJuly 31, 2018
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- clinical research unit of nanoro
- Enrollment
- 942
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Effect of aggressive nutrition strategies on neurodevelopment of preterm babiesHealth Condition 1: null- Inborn Preterm neonates less than or equal to 32 weeks gestation and less than or equal to 1500 gm.Observational study.CTRI/2017/09/009818il260
Recruiting
Phase 1
Human milk lyophilisate - Phase 1 and 2 study: safety, tolerability and effectivenessPreterm newbornHuman MilkHuman Milk BancNewrbornM01.060.703.520M01.060.703.520.520A12.200.467N02.278.065.600RBR-8nnpfmConselho Nacional de Desenvolvimento Científico e Tecnológico
Completed
Not Applicable
The ProVIDe Study. The effect of higher intravenous protein intake for extremely low birthweight babies in the first week after birth on survival free from neurodevelopmental disability at 2 years' corrected age.Extremely preterm birthFaltering growth / postnatal growth restrictionNeurodevelopmental outcome following preterm birthDiet and Nutrition - Other diet and nutrition disordersReproductive Health and Childbirth - Complications of newbornACTRN12612001084875Professor Frank Bloomfield434
Completed
Not Applicable
In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life?Reproductive Health and Childbirth - Complications of newbornACTRN12608000357358Professor Colin J Morley70
Completed
Not Applicable
In extremely low birth weight (ELBW) infants who require positive pressure at birth does the Neopuff Infant Resuscitator compared with the Laerdal Infant Bag improve oxygen saturation measurements in the first ten minutes of life?Oxygen saturation in the first ten minutes of life in infants born at less than 29 weeks gestation who require positive pressure ventilationReproductive Health and Childbirth - Childbirth and postnatal careACTRN12607000062426Professor Colin J Morley76