Calcium Aspirin Multiple Micronutrients (CAMMS) or Iron-folic Acid (IFA) to Reduce Preterm Birth

INV-036663

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.

2024-04-01

2026-06-30

2026-12-31

Withdrawn

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pregnant women will be individually randomized to daily CAMMS or IFA from recruitment (at 6\\<20 weeks gestation) to delivery.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-04-23