Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth (CAMMS)
Preterm Labor, Small for Gestational Age at Delivery, Hypertensive Disorder of Pregnancy
About this trial
This is an interventional prevention trial for Preterm Labor
Eligibility Criteria
Inclusion Criteria: Woman, confirmed pregnant by urinary pregnancy test 6<20 weeks' gestation determined by fetal ultrasound exam; Pregnancy must be intrauterine; multiple fetus pregnancies are eligible. Women must be willing and able to give informed consent; willing to receive antenatal visits at one of the study clinics. In Burkina Faso, women must be willing to take monthly sulfadoxine-pyrimethamine. Exclusion Criteria: Pregnant women who are currently taking aspirin, calcium, or MMS; have a history of peptic ulcer or have any other contraindications to any of the study drugs; have acute or chronic condition that might interfere with the study as judged by the research clinician including severe anemia defined as Hb<5 g/dL; have other reasons which, at the study research physician's discretion, mean that receipt of the study drugs or participation in the trial would not be advisable. NOTE: Women who have been started on IFA by MoH or private health care provider but are willing discontinue the IFA dispensed by MoH and to be randomized to IFA or CAMMS will not be excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Calcium aspirin multiple micronutrients
Iron folic acid
500 mg elemental calcium (as 1250 mg calcium carbonate) 81 mg aspirin 1 tablet United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formula, which is a Multiple Micronutrient Supplement (MMS) for pregnant women
60 mg iron + 400 μg folic acid given as a combined tablet