Preterm LaborPhase 3CAMMSNCT05612984
Calcium Aspirin Multiple Micronutrients (CAMMS) to Reduce Preterm Birth
A Phase 3 study testing Calcium aspirin multiple micronutrients and Iron-folic Acid in people with Preterm Labor and Small for Gestational Age at Delivery, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Preterm Labor, Small for Gestational Age at Delivery, Hypertensive Disorder of Pregnancy
- What is being tested?
- Calcium aspirin multiple micronutrients and Iron-folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Calcium Aspirin Multiple Micronutrients (CAMMS) or Iron-folic Acid (IFA) to Reduce Preterm Birth
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.
Read the detailed description
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.
- Conditions
- Preterm Labor, Small for Gestational Age at Delivery, Hypertensive Disorder of Pregnancy, Low Birth Weight, Neonatal Death
- Being tested
- Calcium aspirin multiple micronutrients, Iron-folic Acid
- Medical subject headings
- Obstetric Labor, Premature, Toxemia, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium aspirin multiple micronutrientsCombination product
Also called CAMMS
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.
Iron-folic AcidDietary supplement
Also called IFA
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.
| Study group | Role | What they receive |
|---|---|---|
| Calcium aspirin multiple micronutrients | Experimental | 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 Receives: Combination Product: Calcium aspirin multiple micronutrients |
| Iron folic acid | Active comparator | 60 mg iron + 400 μg folic acid given as a combined tablet Receives: Dietary Supplement: Iron-folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total preterm birth
Gestational age at birth < 37 weeks, stratified by spontaneous and indicated.
Measured: At birth
Secondary outcomes (16)
Total very early preterm birth
gestational age at birth ≥20 and <28 weeks, stratified by spontaneous and indicated.
Measured: At birth
Total early preterm birth
gestational age ≥28 and <34 weeks, stratified by spontaneous and indicated.
Measured: At birth
Low birth weight
<2500 g
Measured: At birth
Very low birth weigh
<1500 g
Measured: At birth
Small for gestational age
<10th percentile weight for gestational age using INTERGROWTH 21st Reference standards
Measured: At birth
Stillbirth
fetal loss > 20 gestational weeks
Measured: Day of fetal loss from > 20 weeks gestation to birth
Neonatal death
death of a live-born infant <28 completed days of life
Measured: Day of death, between birth and <28 completed days of life
Miscarriage
fetal loss <20 gestational weeks
Measured: Day of fetal loss, up to < 20 weeks gestation
Live-or-stillbirth-preterm-deliveries
stillbirths delivered <37 weeks' gestation + preterm births
Measured: 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
Measured: From enrollment at 6<20 weeks gestation through 42 days postpartum
Maternal anemia
Hb<110 g/L during the third trimester of pregnancy
Measured: 30 weeks' gestation
Maternal death
death of a woman between enrollment at 6<20 weeks gestation and 42 days postpartum
Measured: day of woman's death between enrollment at 6<20 weeks gestation up to 42 days postpartum
Perinatal mortality
Stillbirths + neonatal deaths
Measured: fetal loss or infant death <28 days of completed life
Birth weight
infant weight (g) ≤ 72 h of birth
Measured: At birth
Gestational age at birth
Completed days of gestation at birth
Measured: At birth
Weight-for-gestational-age-Z-score at birth
WAZ, using INTERGROWTH 21st Reference standards
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Apr 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Study grant canceled by donor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women will be individually randomized to daily CAMMS or IFA from recruitment (at 6\<20 weeks gestation) to delivery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University, Institut Africain de Sante Publique, Zvitambo Institute for Maternal and Child Health Research, Christiana Care Health Services, Columbia University
- Responsible party
- Sponsor
- Investigators
- Jean Humphrey, ScD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612984
- Sponsor's protocol ID
- INV-036663
- Acronym
- CAMMS
- Status last verified
- Apr 2024
- First submitted
- 3 Nov 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will deposit anonymized data in an existing repository after publication of the primary and key secondary findings. (
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Aspirin Multiple Micronutrients (CAMMS) or Iron-folic Acid (IFA) to Reduce Preterm Birth
- ClinicalTrials.gov ID
- NCT05612984
- Acronym / sponsor ID
- CAMMS / INV-036663
- Conditions
- Preterm Labor, Small for Gestational Age at Delivery, Hypertensive Disorder of Pregnancy, Low Birth Weight, Neonatal Death
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study grant canceled by donor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Aga Khan University, Institut Africain de Sante Publique, Zvitambo Institute for Maternal and Child Health Research, Christiana Care Health Services, Columbia University
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant women will be individually randomized to daily CAMMS or IFA from recruitment (at 6<20 weeks gestation) to delivery.
| Arm | Type | Receives |
|---|---|---|
| Calcium aspirin multiple micronutrients | Experimental | Combination Product: Calcium aspirin multiple micronutrients500 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 |
| Iron folic acid | Active comparator | Dietary Supplement: Iron-folic Acid60 mg iron + 400 μg folic acid given as a combined tablet |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium aspirin multiple micronutrientsAlso: CAMMSWomen 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. | Combination product | Calcium aspirin multiple micronutrients |
| Iron-folic AcidAlso: IFAWomen 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. | Dietary supplement | Iron folic acid |
Primary outcome
Total preterm birth
Time frame: At birth
Gestational age at birth < 37 weeks, stratified by spontaneous and indicated.
16 secondary outcomes
Total very early preterm birth
Time frame: At birth
Total early preterm birth
Time frame: At birth
Low birth weight
Time frame: At birth
Very low birth weigh
Time frame: At birth
Small for gestational age
Time frame: At birth
Stillbirth
Time frame: Day of fetal loss from > 20 weeks gestation to birth
Neonatal death
Time frame: Day of death, between birth and <28 completed days of life
Miscarriage
Time frame: Day of fetal loss, up to < 20 weeks gestation
Live-or-stillbirth-preterm-deliveries
Time frame: Day of fetal loss or birth, up to < 37 weeks gestation
Hypertensive disorder of pregnancy
Time frame: From enrollment at 6<20 weeks gestation through 42 days postpartum
Maternal anemia
Time frame: 30 weeks' gestation
Maternal death
Time frame: day of woman's death between enrollment at 6<20 weeks gestation up to 42 days postpartum
Perinatal mortality
Time frame: fetal loss or infant death <28 days of completed life
Birth weight
Time frame: At birth
Gestational age at birth
Time frame: At birth
Weight-for-gestational-age-Z-score at birth
Time frame: At birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Yes. We will deposit anonymized data in an existing repository after publication of the primary and key secondary findings. (
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Humphrey, ScD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium aspirin multiple micronutrients and Iron-folic Acid in people with Preterm Labor and Small for Gestational Age at Delivery, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total preterm birth (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.