A Phase 3 interventional study of Calcium aspirin multiple micronutrients and Iron-folic Acid in Preterm Labor, Small for Gestational Age at Delivery and Hypertensive Disorder of Pregnancy, sponsored by Johns Hopkins Bloomberg School of Public Health. Withdrawn. Open to female participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Prevention
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.
The CAMMS trial is an individually randomized, unblinded, phase III trial comparing aspirin, calcium and multiple micronutrients (intervention) versus iron-folic acid (control) among 10,000 pregnant women. The primary outcome is total preterm birth, stratified by spontaneous and indicated. Eligible pregnant women will be enrolled from antenatal clinics in three study populations in Burkina Faso, Pakistan, and Zimbabwe following written informed consent.
All women attending antenatal care (ANC) who are positive on a urine pregnancy test and have a fetal ultrasound examination confirming fetal heartbeat, intrauterine pregnancy, and gestational age 6\<20 weeks' will be eligible for enrollment. Women who are \<6 weeks will be rescheduled for 2-3 weeks later. Baseline data and clinical assessments will be conducted, and women will be randomized to daily ingestion of CAMMS or IFA until delivery. In Burkina Faso, for women randomized to CAMMS, the aspirin will be withheld until 13 weeks' gestation when it can be initiated concurrently with sulfadoxine-pyrimethamine. Women will receive context-specific adherence promotion interventions designed during formative research incorporating Human-Centered Design (HCD) processes in each country. Mothers will be followed up at 4-weekly intervals throughout pregnancy plus an additional study contact (by visit, phone call, WhatsApp, or text message) at 1-2 weeks after starting the study drug to check for tolerance and adherence. Women may also be seen at closer intervals in the third trimester by the Ministry of Health clinics. Women will be encouraged to deliver in a health institution.
Between baseline and delivery, research procedures will be undertaken by research staff based at antenatal clinics during mothers' routine antenatal visits to reduce time burden on participants. Depending on gestational age at recruitment, women will receive 7-11 research visits. One additional visit or contact by text-message (SMS) or phone call will occur one-two weeks after randomization to check that the women is tolerating and correctly taking the interventions.
At delivery, infant weight and gestational age will be measured/determined by research staff based at delivery clinics or, for home deliveries, during home visits conducted within 72 hours of delivery. For infants born outside the study area or who are not reached by research staff within 72 hours, date of birth and birth weight will be transcribed from the infant's health record with source of information noted. In unusual situations where the mother and infant cannot be reached in person before 180 days postpartum but can be reached by telephone, WhatsApp, or Text message, maternal report of data of birth and birth weight will be recorded with the source of information noted. For all infants reached by a research staff member within 72 hours of birth, birth length and head circumference will be measured by standardized research staff with high quality equipment (length measured to nearest 0.1cm with infant length board and Shorr insert-tape (Weigh \& Measure LLC., Olney, MD, USA). Mothers and infants will be followed to 42 days post-partum for vital status and post-partum maternal Adverse Events (AEs) and Serious Adverse Events (SAEs). This visit may be conducted in person, by telephone, WhatsApp or text message with the source of information recorded.
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Exclusion Criteria:
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.
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
Combination Product: Calcium aspirin multiple micronutrients
60 mg iron + 400 μg folic acid given as a combined tablet
Dietary Supplement: Iron-folic Acid
Women randomized to CAMMS will receive weekly blister cards containing all 3 components: 1 81 mg aspirin tablet, 1 UNIMMAP MMS, and 1 500-mg elemental calcium tablets. Blister packages will be labeled with times of day and days of week when tablets are to be taken. 4 weekly blister cards will be packaged in one unit box.
Also known as: CAMMS
Women randomized to IFA will receive monthly (28-day) blister cards containing containing 1 combined IFA tablet to be taken each day. 1 4-weekly blister card will be packaged in one unit box.
Also known as: IFA
Total preterm birth
Gestational age at birth \< 37 weeks, stratified by spontaneous and indicated.
Time frame: At birth
Total very early preterm birth
gestational age at birth ≥20 and \<28 weeks, stratified by spontaneous and indicated.
Time frame: At birth
Total early preterm birth
gestational age ≥28 and \<34 weeks, stratified by spontaneous and indicated.
Time frame: At birth
Low birth weight
\<2500 g
Time frame: At birth
Very low birth weigh
\<1500 g
Time frame: At birth
Small for gestational age
\<10th percentile weight for gestational age using INTERGROWTH 21st Reference standards
Time frame: At birth
Stillbirth
fetal loss \> 20 gestational weeks
Time frame: Day of fetal loss from > 20 weeks gestation to birth
Neonatal death
death of a live-born infant \<28 completed days of life
Time frame: Day of death, between birth and <28 completed days of life
Miscarriage
fetal loss \<20 gestational weeks
Time frame: Day of fetal loss, up to < 20 weeks gestation
Live-or-stillbirth-preterm-deliveries
stillbirths delivered \<37 weeks' gestation + preterm births
Time frame: Day of fetal loss or birth, up to < 37 weeks gestation
Hypertensive disorder of pregnancy
Maternal Systolic BP\>140 and/or Diastolic BP\>90 between enrollment and 42 days postpartum
Time frame: From enrollment at 6<20 weeks gestation through 42 days postpartum
Maternal anemia
Hb\<110 g/L during the third trimester of pregnancy
Time frame: 30 weeks' gestation
Maternal death
death of a woman between enrollment at 6\<20 weeks gestation and 42 days postpartum
Time frame: day of woman's death between enrollment at 6<20 weeks gestation up to 42 days postpartum
Perinatal mortality
Stillbirths + neonatal deaths
Time frame: fetal loss or infant death <28 days of completed life
Birth weight
infant weight (g) ≤ 72 h of birth
Time frame: At birth
Gestational age at birth
Completed days of gestation at birth
Time frame: At birth
Weight-for-gestational-age-Z-score at birth
WAZ, using INTERGROWTH 21st Reference standards
Time frame: At birth
Infant birth length and birth head circumference
Among infants assessed \<72 hours after birth by research staff
Time frame: birth
Tolerance of CAMMS compared to IFA
Rates of Grade 1 or 2 nausea, vomiting, rash/hives, diarrhea, constipation, and vaginal bleeding from initiation of the interventions through 42 days post-partum
Time frame: Up to 42 days post-partum
Safety of CAMMS compared to IFA
Rates of SAEs, Grade 3 or 4 nausea, vomiting, rash/hives, diarrhea, constipation, and vaginal bleeding, stratified by relatedness to the intervention from initiation of the interventions through 42 days post-partum
Time frame: Up to 42 days post-partum
No study locations are listed for this record.
Plan to share: Yes — We will deposit anonymized data in an existing repository after publication of the primary and key secondary findings. (
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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