A Phase 4 interventional study of triple attack therapy and Ferrous(II)-glycine-sulphate complex 567.7 mg capsules in Pregnancy Complications, Anemia, Iron Deficiency and H Pylori Infection, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged Up to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Treatment
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Among 16 studies in Pregnancy Complications with a site in Egypt — 1 open to participants now, 1 under way, none of them phase 3. Pregnancy Complications · Egypt.
Among the 16 studies in Pregnancy Complications with a site in Egypt, this one is the 3rd largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2017, is one of 2 in phase 4, and was the 5th registered.
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
Browse Pregnancy Complications studies →1 of the 16 studies in Pregnancy Complications with a site in Egypt is open now. Recruiting first, the newest first:
Ain Shams University · Sites in Egypt
Ages 16+ · Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 92 Pregnancy Complications studies recruiting now, 44 (48%) set no upper age limit and 45 (49%) stop at 75 or younger; 22 take children under 18; 35 take healthy volunteers.
This study: Up to 40 Years · female · healthy volunteers too.
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16 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is close to the median of 144 across 205 interventional studies indexed under Pregnancy Complications.
Median enrollment 70 across the 11 interventional studies, 121 across the 5 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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None of the 16 has an industry lead sponsor. The 8 most frequent:
Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.
Kasr El Aini Hospital has 1 study filed under Pregnancy Complications — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Pregnancy Complications with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
the effect of eradication of H-pylori in pregnant patients with iron deficiency anemia on the level of hemoglobin after iron therapy.
After approval of the "Ethics Committee" of the obstetrics and gynecology department of the faculty of medicine Cairo University, a clinical trial will be started in which pregnant patients with iron deficiency anemia will be recruited out of the antenatal care clinic. Routine complete blood count (CBC) is done early during the second trimester for cases with anemia discovered by labs drawn on their booking appointment during their 1st antenatal care visit.
IDA defined as hemoglobin below 11gm/dl with MCV below 80 fl, with one of the following: if the serum ferritin level is below 70 μg/L. or if transferrin saturation is below 20.
We based our sample size according to the work done by Nashaat \& Mansour, 2014 who studied a difference in the mean hemoglobin level of 1.6 g/dl with a standard deviation of 3.3. The ratio of women in the control group to experimental group was set at 1:1, the power at 0.8, and the type I error at 0.05 which gave us 68 subjects in every arm. We allowed for 10% dropouts finally giving us 75 subjects on each study arm.
After obtaining informed consent, H-pylori infection will be diagnosed using a stool antigen assay ABON which is one step H. pylori antigen test device (®Inverness Medical Innovation Hong Kong Limited). A stool sample will be collected and the top screwed on. An applicator will then be introduced into the sample after unscrewing of the cap in three different sites to collect at least 50 mg of fecal matter. The sample will be centrifuged at 4000 rpm for 5 minutes and the supernatant will be used for immunoassay. Two drops will be placed on the kit as per kit instructions. This test utilizes lateral chromatographic assay where after 10 minutes a positive sample will have a purple-pink line in addition to the control line, while a negative test only has the control line present. If the control line was missing the test will be considered invalid.
All the enrolled participants will then be randomized into two groups using a computer generated randomization table and a sealed envelope system to be opened by the nurse in the next antenatal care visit. When the envelope is opened the participant will be assigned to either group (A) (eradication of H-pylori before iron therapy) or group (B) (start iron therapy without eradication o f H-pylori).
Participants in group A will undergo eradication of H-pylori using triple attack therapy according to O'Connor et al, 2013 with Proton pump inhibitor (eg, omeprazole 20 mg BID), Clarithromycin 500 mg BID, metronidazole 500 mg BID for 14 days, followed by confirmation of eradication by repeating the H-pylori stool antigen test .
Iron therapy will be given to both groups twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm , Egypt. All recruited cases will undergo blood sampling for complete blood count (CBC), serum ferritin, transferrin saturation, and total iron binding capacity (TIBC) before and after iron therapy. All demographic data along with relevant history taking and examination will be recorded at the beginning of recruitment including age, body mass index (BMI), and parity e.t.c.
PS Power and Sample Size Calculations software, version 2.1.30 for MS Windows, was used to calculate sample size (Dupont and Vanderbilt, Nashville, TN).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
triple attack therapy (Clarithromycin 500 mg BID for 14 days, omeprazole 20 mg BID for 14 days, metronidazole 500 mg BID for 14 days). Followed by confirmation of eradication by repeating the H-pylori stool antigen test. Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
Drug: triple attack therapy · Drug: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules
Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
Drug: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules
eradication of H-pylori using triple attack therapy.
Also known as: KLACID XL 500 mg, HEALSEC 20 mg, Flagyly 500 mg
Iron therapy will be given to both groups twice daily for one month.
Also known as: Ferro sanol duodenal ®Minapharm , Egypt
hemoglobin levels
difference in mean mean hemoglobin levels
Time frame: one month
Plan to share: No
Started Nov 2017 (actual). Primary completion is estimated for Mar 2019, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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