Anemia of PregnancyPhase 4NCT04391998
Parasitic Infection in Anemic Pregnant Women
A Phase 4 study testing Iron Supplement, Metronidazole Oral and Albendazole in people with Anemia of Pregnancy, run by Cairo University at 1 site in Egypt.
Trial summary
Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anemia of Pregnancy
- What is being tested?
- Iron Supplement, Metronidazole Oral and Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2020to Sep 2021
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound)
- hemoglobin level below 10.5 mg /dL
Who cannot join
- women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders
- women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis.
- Women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL.
Read the detailed description
All patients in the study were subjected to:
- Detailed history was recorded. A proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. Participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, Diet, and information useful to determine the socioeconomic level was recorded. Information on previous pregnancies and children and history of chronic diseases were also recorded.
- General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant.
- Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration.
- Diagnosis of parasitic infection by stool analysis using suitable techniques.
- Imaging including obstetric ultrasound (U/S) to assess fetal development.
- Women with helminthic infections will be divided into groups
Group (A): received iron + antiparasitic treatment as follows:
- Patients who have STH received alzental 200mg tab 2 tabs single oral dose.
- Patients who have Entamoeba or Giardia received flagyl 500mg tab twice daily for 5 days.
- (B): received iron only.
- Conditions
- Anemia of Pregnancy
- Being tested
- Iron Supplement, Metronidazole Oral, Albendazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SupplementDrug
Also called Ferroglobin
oral tablet twice daily after meals
Metronidazole OralDrug
Also called Flagyl
500 mg oral twice daily
AlbendazoleDrug
Also called alzental
200 mg oral single dose
| Study group | Role | What they receive |
|---|---|---|
| Anemia without parasitic infection | Active comparator | women with anemia without parasitic infection will receive iron treatment Receives: Drug: Iron Supplement |
| parasitic infection treated with iron | Active comparator | women with anemia with parasitic infection will receive oral iron treatment Receives: Drug: Iron Supplement |
| parasitic infection treated with iron and antihelmemsic | Active comparator | women with anemia with parasitic infection will receive oral iron treatment and antihelminsic treatment in the form of metronidazole 500mg tab twice daily for 5 days in cases with Entamoeba or Giardia or albendazol 200mg tab Receives: Drug: Iron Supplement; Drug: Metronidazole Oral; Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
correction of naemia
hemoglobin level increased above 11 gm/dL
Measured: 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start13 May 2020
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391998
- Sponsor's protocol ID
- 175
- Status last verified
- Feb 2021
- First submitted
- 13 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
- ClinicalTrials.gov ID
- NCT04391998
- Acronym / sponsor ID
- 175
- Conditions
- Anemia of Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 May 2020 (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.
Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL.
Detailed description
All patients in the study were subjected to:
- Detailed history was recorded. A proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. Participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, Diet, and information useful to determine the socioeconomic level was recorded. Information on previous pregnancies and children and history of chronic diseases were also recorded.
- General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant.
- Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration.
- Diagnosis of parasitic infection by stool analysis using suitable techniques.
- Imaging including obstetric ultrasound (U/S) to assess fetal development.
- Women with helminthic infections will be divided into groups
Group (A): received iron + antiparasitic treatment as follows:
- Patients who have STH received alzental 200mg tab 2 tabs single oral dose.
- Patients who have Entamoeba or Giardia received flagyl 500mg tab twice daily for 5 days.
- (B): received iron only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anemia without parasitic infection | Active comparator | Drug: Iron Supplementwomen with anemia without parasitic infection will receive iron treatment |
| parasitic infection treated with iron | Active comparator | Drug: Iron Supplementwomen with anemia with parasitic infection will receive oral iron treatment |
| parasitic infection treated with iron and antihelmemsic | Active comparator | Drug: Iron Supplement, Drug: Metronidazole Oral, Drug: Albendazolewomen with anemia with parasitic infection will receive oral iron treatment and antihelminsic treatment in the form of metronidazole 500mg tab twice daily for 5 days in cases with Entamoeba or Giardia or albendazol 200mg tab |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound)
- hemoglobin level below 10.5 mg /dL
Key exclusion criteria (3 listed)
- women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders
- women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis.
- Women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also 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 |
|---|---|---|
| Iron SupplementAlso: Ferroglobinoral tablet twice daily after meals | Drug | Anemia without parasitic infection, parasitic infection treated with iron, parasitic infection treated with iron and antihelmemsic |
| Metronidazole OralAlso: Flagyl500 mg oral twice daily | Drug | parasitic infection treated with iron and antihelmemsic |
| AlbendazoleAlso: alzental200 mg oral single dose | Drug | parasitic infection treated with iron and antihelmemsic |
Primary outcome
correction of naemia
Time frame: 6 weeks after treatment
hemoglobin level increased above 11 gm/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed maged, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Supplement, Metronidazole Oral and Albendazole in people with Anemia of Pregnancy, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed maged, MD (+201005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correction of naemia (time frame: 6 weeks after treatment). 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 9 Feb 2021.