Oral Iron in Pregnant Women: How Often to Take It and Its Side Effects and Tolerability (NCT07356258) | Clinical Trial Compass
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Oral Iron in Pregnant Women: How Often to Take It and Its Side Effects and Tolerability
Israel50 participantsStarted 2026-02-01
Plain-language summary
The goal of this prospective observational study is to examine the frequency of gastrointestinal side effects associated with oral iron supplementation during pregnancy. The main question it aims to answer is:
Does intermittent oral iron supplementation result in fewer gastrointestinal side effects compared with daily supplementation in pregnant women? Pregnant women who are prescribed oral iron as part of their routine medical care will take ferrous sulfate on an alternate-day schedule for one week. If no significant gastrointestinal side effects are reported, they will then take ferrous sulfate daily for an additional week and will be followed for one month. Participants will be contacted by the study investigator to report gastrointestinal side effects, and routine blood tests will be used to assess changes in hemoglobin and iron stores.
Who can participate
Age range
18 Years – 50 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:
* Pregnant women aged 18-50
* Indication for oral iron treatment as determined by the treating physician, in accordance with standard clinical practice
* Baseline iron store levels measured prior to initiation of oral iron therapy
Exclusion Criteria:
* Women taking ferrous sulfate 80 mg Tardiferon
* Gastrointestinal diseases such as colitis
* Women who received intravenous iron during pregnancy
* Women who received blood transfusions during pregnancy
* Women with anemia due to causes other than iron deficiency
* History of bariatric surgery
* Allergy to ferrous sulfate
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
Incidence of gastrointestinal side effects in response to iron intake
Timeframe: Over the first 2 weeks of supplementation, with structured follow-up at week 1 and week 2