Efficacy of a combined drug containing ferrous fumarate and folic acid in anemia in the second trimester of pregnancy: results of a multicenter study
Objective: To evaluate the effect of ferrous fumarate/folic acid (FF/FA) on the clinical and laboratory signs of anemia in pregnant women in the second trimester. Materials and methods: The investigation enrolled 160 women at 14 to 20 weeks’ gestation who were diagnosed with anemia and were prescribed FF/FA. Results: The use of FF/FA caused a significant improvement in clinical and biochemical blood test results reflecting the severity of anemia: an increase in Hb, Ht, RBC, MCV, MCH, MCHC, serum iron, and ferritin, a decrease in the frequency of microcytosis and serum latent iron-binding capacity. After 3 months of therapy, the total study population displayed an increase in mean values of HgB from 102.0 to 117.0 g/l, ferritin from 46.2 to 55.9 µg/l, serum iron from 12.02 to 20.49 µmol/l. The proportion of patients without anemia was 77% (118/153); that with mild and moderate anemia were 20% (31/153), and 2% (3/153), respectively, which shows a significant improvement compared to that at the start of therapy. In the group with iron deficiency anemia (IDA), (Hb<110 g/l, ferritin<30 µg/l), Hb increased from an average of 103.3 to 109.8 g/l, ferritin from 14.4 to 24.3 µg/l, serum iron from 11.87 to 20.53 µmol/l. After 3 months, mild and moderate IDA was present in 30% (28/93) and 3% (3/93) patients, respectively. Conclusion. The findings are comparable with international and Russian data and can conclude that FF/FA is an effective and safe way to correct IDA in pregnant women and is suitable for long-term use. Authors’ contributions: Pavlovich S.V., Melikhov O.G. – development of the concept and design of the investigation, writing the text; Pavlovich S.V., Abashova E.I., Chulkov V.S., Nazipova Z.M., Savelyeva I.V., Andreeva M.D., Kudlai Yu.V., Enkova E.V., Khodzhaeva Z.S., Muminova K.T., Sakalo V.A., Gorodnova E.A., Zaripova A.Sh., Melikhov O.G. – material collection and processing, editing; Melikhov O.G. – statistical data processing; Melikhov O.G., Pavlovich S.V. – analysis of literature data. Conflicts of interest: The authors declare that there are no conflicts of interest. Fundind: This investigation has not been sponsored by Acino Rus Co. Patient Consent for Publication: The patients have signed an informed consent form to their participation in the investigation and to the publication of their data. Authors' Data Sharing Statement: The data supporting the conclusions of this investigation are available upon request from the corresponding author after approval by the research supervisor of the project. For citation: Pavlovich S.V., Melikhov O.G., Khodzhaeva Z.S., Muminova K.T., Sakalo V.A., Gorodnova E.A., Abashova E.I., Yarmolinskaya M.I., Chulkov V.S., Nazipova Z.M., Savelyeva I.V., Andreeva M.D., Kudlai Yu.V., Enkova E.V., Zaripova A.Sh. Efficacy of a combined drug containing ferrous fumarate and folic acid in anemia in the second trimester of pregnancy: results of a multicenter study. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; 2: 108-116 (in Russian) https://dx.doi.org/10.18565/aig.2023.51Pavlovich S.V., Melikhov O.G., Khodzhaeva Z.S., Muminova K.T., Sakalo V.A., Gorodnova E.A., Abashova E.I., Yarmolinskaya M.I., Chulkov V.S., Nazipova Z.M., Savelyeva I.V., Andreeva M.D., Kudlai Yu.V., Enkova E.V., Zaripova A.Sh.
Keywords
anemia
iron deficiency anemia
iron preparations
folic acid
pregnancy
second trimester
hemoglobin
ferritin
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Received 20.02.2023
Accepted 27.02.2023
About the Authors
Stanislav V. Pavlovich, PhD, Academic Secretary, Academician V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia; Professor, Department of Obstetrics, Gynecology, Perinatology and Reproductology, I.M. Sechenov First MSMU, Ministry of Health of Russia (Sechenov University), +7(495)438-20-88, s_pavlovich@oparina4.ru,https://orcid.org/0000-0002-1313-7079, 117997, Russia, Moscow, Akademika Oparina str., 4.
Oleg G. Melikhov, PhD, Director, Institute of Clinical Research; Chairman, Scientific Society “League of Clinical Research”, +7(916)695-05-30, melikhov.oleg@gmail.com, https://orcid.org/0000-0001-9442-7707, 119590, Russia, Moscow, Ulof Palme str., 1.
Zulfiya S. Khodzhaeva, Dr. Med. Sci., Professor, Deputy Director of Obstetrics Institute, Professor at the Department of Obstetrics, Gynecology, Perinatology of the Department of Professional Education, Academician V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia, +7(495)438-07-88, zkhodjaeva@mail.ru,
https://orcid.org/0000-0001-8159-3714, 117997, Russia, Moscow, Ac. Oparina str., 4.
Kamilla T. Muminova, PhD, Researcher at the High Risk Pregnancy Department, Academician V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia, +7(495)438-06-74, kamika91@mail.ru, https://orcid.org/0000-0003-2708-4366, 117997, Russia, Moscow, Ac. Oparina str., 4.
Viktoriya A. Sakalo, PhD, Junior Researcher at the Department of Pregnancy Pathology, Institute of Obstetrics, doctor at the 1st Obstetric Department of Pregnancy Pathology, Academician V.I. Kulakov NMRC for OG&P, Ministry of Health of Russiaa, +7(929)588-72-08, v_sakalo@oparina4.ru, https://orcid.org/0000-0002-5870-4655, 117997, Russia, Moscow, Ac. Oparina str., 4.
Elena A. Gorodnova, PhD, MPH (Master of Public Health), Head of Scientific & Clinical Center, Academician V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia, +7(495)531-44-44, e_gorodnova@oparina4.ru, Author ID Scopus 6508176604, Author ID 597062, https://orcid.org/0000-0003-39937629,
117997, Russia, Moscow, Ac. Oparina str., 4.
Elena I. Abashova, PhD, Senior Researcher, Department of Gynecology and Endocrinology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, +7(812)328-98-20, +7(921)945-90-90, abashova@yandex.ru, https://orcid.org/0000-0003-2399-3108, SPIN-код: 2133-0310,
199034, Russia, St. Petersburg, Mendeleevskaya line, 3.
Maria I. Yarmolinskaya, Professor of RAS, Dr. Med. Sci., Professor, Head of the Department of Gynecology and Endocrinology, Head of Center “Diagnostics and treatment of endometriosis”, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; Professor at the Department of Obstetrics and Gynecology, I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, m.yarmolinskaya@gmail.com, https://orcid.org/0000-0002-6551-4147, eLibrary SPIN-код: 3686-3605,
199034, Russia, St. Petersburg, Mendeleevskaya line, 3.
Vasilii S. Chulkov, Dr. Med. Sci., Professor at the Department of Faculty Therapy, South-Ural State Medical University, Ministry of Health of Russia, vschulkov@rambler.ru,
https://orcid.org/0000-0002-0952-6856, 454092, Russia, Chelyabinsk, Vorovskogo str., 64.
Zulfira M. Nazipova, hematologist, Republican Clinical Hospital, Ministry of Health of the Republic of Tatarstan, +7(905)376-21-36, zulfira93@mail.ru,
https://orcid.org/0009-0002-3591-522Х, 420064, Russia, Republic of Tatarstan, Kazan, Orenburgsky Trakt str., 138.
Irina V. Savelyeva, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology No. 1, Omsk State Medical University, Ministry of Health of Russia, +7(913)654-35-77, saveljeva_iv_omsk@mail.ru, https://orcid.org/0000-0001-9342-7342, 644099, Russia, Omsk, Lenina str., 12.
Margarita D. Andreeva, Dr. Med. Sci., Associate Professor, Professor at the Department of Obstetrics, Gynecology and Perinatology, Faculty of Postgraduate Education, Kuban State Medical University, Ministry of Health of Russia, andreeva_md@mail.ru, https://orcid.org/0000-0002-6524-3965, 350063, Russia, Krasnodar, M. Sedina str., 4.
Yulia V. Kudlai, student of the Faculty of Pediatrics, Kuban State Medical University, Ministry of Health of Russia, +7(988)188-78-92, kudlai.j@yandex.ru,
https://orcid.org/0000-0002-3192-7170, 350063, Russia, Krasnodar, M. Sedina str., 4.
Elena V. Enkova, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology No. 2, N.N. Burdenko Voronezh State Medical University,
Ministry of Health of Russia, enkova@bk.ru, https://orcid.org/0000-0001-8885-1587, 394036, Russia, Voronezh, Studentskaya str., 10.
Aliya Sh. Zaripova, postgraduate student of the Department of Obstetrics and Gynecology named after V.S. Gruzdev, Kazan State Medical University,
Ministry of Health of Russia; Chief Physician of MC "Nurmed", obstetrician-gynecologist, ultrasound diagnostics doctor, +7(917)250-50-70, zaripovaash@yandex.ru,
https://orcid.org/0000-0002-2701-319X, 420012, Russia, Kazan, Butlerov str., 49.
Corresponding author: Oleg G. Melikhov, melikhov.oleg@gmail.com
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