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NCT05612984
Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth
Conditions: Preterm Labor, Small for Gestational Age at Delivery, Hypertensive Disorder of Pregnancy, Low Birth Weight, Neonatal Death
Sex: Female
Ages: 15 Years – N/A
Phase: PHASE3
Enrollment: 12000
Sponsor: Johns Hopkins Bloomberg School of Public Health
Summary
This trial will evaluate the impact of an integrated intervention of daily maternal calcium, aspirin, and multiple micronutrients (CAMMS) compared to iron-folic acid (IFA) during pregnancy on preterm birth and other adverse birth outcomes.
Both interventions will be delivered through existing antenatal service platforms using context-specific strategies informed by formative research incorporating human-centered design processes to achieve high acceptability and high adherence, in three low-income countries with diverse contexts: Burkina Faso, Pakistan, and Zimbabwe.
Eligibility Criteria
Inclusion Criteria:Pregnant women 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 any acute or chronic condition that might interfere with the study as judged by the research clinician; 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.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.
Source: ClinicalTrials.gov (NCT05612984). StuddyBuddy aggregates publicly available trial information.