Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth
Stopped: Study grant canceled by donor
0Started 2024-04-01
Plain-language 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.
Who can participate
Age range
15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total preterm birth
Timeframe: At birth
Trial details
NCT IDNCT05612984
SponsorJohns Hopkins Bloomberg School of Public Health