Anemia in PregnancyNCT02839096
Once Versus Twice Daily Iron Supplementation in Pregnant Women
A study testing Ferrous Sulfate in people with Anemia in Pregnancy, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia in Pregnancy
- What is being tested?
- Ferrous Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton gestation
- Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
- In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
- In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.
Who cannot join
- Multiple gestation
- Maternal hemoglobinopathy or hemochromatosis,
- Irritable bowel disease or irritable bowel syndrome
- History of bariatric surgery or extensive bowel surgery
- Individuals already receiving iron supplementation aside from prenatal vitamins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation
Read the detailed description
Women defined as having iron deficiency anemia based on a low hemoglobin as defined by the American College of Obstetrics and Gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg PO daily or PO twice daily.
- Conditions
- Anemia in Pregnancy
- Being tested
- Placebo, Ferrous Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Iron
Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous SulfateDrug
Also called Iron
Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Once Daily Dosing | Other | Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening Receives: Drug: Placebo; Drug: Ferrous Sulfate |
| Twice Daily Dosing | Other | Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.
Measured: Change in hemoglobin from baseline to one day postpartum
Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire
Record the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.
Measured: From enrollment to delivery, which will be an average of 10-12 weeks
Secondary outcomes (1)
Incidence of Blood Transfusion at Delivery
The number of patients who received a blood product transfusion at delivery.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019
- Study completionDec 2019
Why it stopped: Lack of funds, PI left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia in PregnancyStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mistie Mills, University of Missouri-Columbia
- Investigators
- Mistie P Mills, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839096
- Sponsor's protocol ID
- 2004638
- Status last verified
- Aug 2024
- First submitted
- 9 Jun 2016
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The final dataset will include (1) demographics, (2) baseline/postpartum hematocrit and levels of hemoglobin, ferritin and hepcidin, and (3) clinical data related to the pregnancy and outcomes. Protected personal information will be removed by trained staff at the Ob/Gyn Clinical Research Unit according to HIPAA guidelines. The final dataset will identify participants by a study number and dates will be replaced by time intervals. Data release is restricted to users under a data-transfer agreement (DTA) that provides for (1) a commitment to using the data only for research purposes and not to seek to identify any individual participant; (2) restrictions on redistribution of data to third parties, (3) a commitment to securing data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed. Upon DTA completion, access will be granted to a secured, cloud-based dataset monitored by the Information Technology Department.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Daily Versus Twice Daily Iron Supplementation to Treat Anemia in Pregnancy: A Prospective, Randomized, Placebo Controlled, Double Blinded, Clinical Trial
- ClinicalTrials.gov ID
- NCT02839096
- Acronym / sponsor ID
- 2004638
- Conditions
- Anemia in Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds, PI left University
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation
Detailed description
Women defined as having iron deficiency anemia based on a low hemoglobin as defined by the American College of Obstetrics and Gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg PO daily or PO twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once Daily Dosing | Other | Drug: Placebo, Drug: Ferrous SulfateRandomized to 325mg of ferrous sulfate in the morning and placebo in the evening |
| Twice Daily Dosing | Other | Drug: Ferrous SulfateRandomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton gestation
- Iron deficiency anemia as defined by a Hgb of less than 11mg/dL in the first and 3rd trimester and 10.5mg/dL in the 2nd trimester and a serum ferritin of less than 15ug/mL.
- In accordance with American College of Obstetricians and Gynecologists (ACOG) guidelines, the Hgb cutoff will be reduced by 0.8mg/dL in African American women.
- In accordance with the standard of care, African American women and those with a mean corpuscular volume (MCV) on their routine screening complete blood count (CBC) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment.
Key exclusion criteria (5 listed)
- Multiple gestation
- Maternal hemoglobinopathy or hemochromatosis,
- Irritable bowel disease or irritable bowel syndrome
- History of bariatric surgery or extensive bowel surgery
- Individuals already receiving iron supplementation aside from prenatal vitamins.
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 |
|---|---|---|
| PlaceboAlso: IronCellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate | Drug | Once Daily Dosing |
| Ferrous SulfateAlso: IronSubjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo. | Drug | Once Daily Dosing, Twice Daily Dosing |
Primary outcome
Hemoglobin
Time frame: Change in hemoglobin from baseline to one day postpartum
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.
Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire
Time frame: From enrollment to delivery, which will be an average of 10-12 weeks
Record the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.
1 secondary outcome
Incidence of Blood Transfusion at Delivery
Time frame: At delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The final dataset will include (1) demographics, (2) baseline/postpartum hematocrit and levels of hemoglobin, ferritin and hepcidin, and (3) clinical data related to the pregnancy and outcomes. Protected personal information will be removed by trained staff at the Ob/Gyn Clinical Research Unit according to HIPAA guidelines. The final dataset will identify participants by a study number and dates will be replaced by time intervals. Data release is restricted to users under a data-transfer agreement (DTA) that provides for (1) a commitment to using the data only for research purposes and not to seek to identify any individual participant; (2) restrictions on redistribution of data to third parties, (3) a commitment to securing data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed. Upon DTA completion, access will be granted to a secured, cloud-based dataset monitored by the Information Technology Department.
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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.
Mistie P Mills, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate in people with Anemia in Pregnancy, run by University of Missouri-Columbia at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin (time frame: Change in hemoglobin from baseline to one day postpartum). The study lists 2 primary outcomes in all. 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 19 Sep 2024.