Method for treating pregnant women with immune hydrops fetalis due to rhesus incompatibility
The method of membrane plasmapheresis and photomodified autologous plasma transfusion addresses the unfavorable outcomes of Rh-conflict treatments by enhancing fetal health and preventing severe hemolysis, leading to improved perinatal results.
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- FEDERALNOE GOSUDARSTVENNOE BYUDZHETNOE OBRAZOVATELNOE UCHREZHDENIE VYSSHEGO OBRAZOVANIYA SANKT PETERBURGSKIJ GOSUDARSTVENNYJ PEDIATRICHESKIJ MEDITSINSKIJ UNIV MINISTSTVA ZDRAVOOKHRANENIYA ROSSIJSKOJ FEDERATSII FGBOU VO SPBGPMU MINZDRAVA ROSSII
- Filing Date
- 2025-11-12
- Publication Date
- 2026-06-30
AI Technical Summary
Current treatments for immune hydrops fetalis due to Rh-conflict, such as intrauterine intravascular transfusions, result in unfavorable perinatal outcomes like fetal mortality and severe asphyxia, and existing methods like hemosorption exacerbate fetal edema and require unsafe antibacterial therapy.
A method involving membrane plasmapheresis and photomodified autologous plasma transfusion is administered to the mother before fetal transfusions, removing toxic substances and Rh antibodies, and returning photomodified plasma to enhance specific prevention of fetal erythrocyte hemolysis, thereby maintaining fetal health.
This approach reduces fetal anemia and hydrops, prevents severe hemolysis, and improves perinatal outcomes by avoiding intensive therapies and transfusions, ensuring the survival of the fetus and a healthy delivery.
Abstract
Description
[0001] The invention relates to medicine, in particular to obstetrics, perinatology, transfusiology, and can be used in the treatment of pregnant women with immune hydrops fetalis (IHF) in case of Rh-conflict.
[0002] The destruction of red blood cells and the development of progressive anemia in the fetus occurs as a result of immune and toxic hemolysis under the influence of Rh antibodies and toxic metabolites.
[0003] IVP in Rh incompatibility is one of the leading causes of perinatal morbidity and mortality. Currently, the generally accepted treatment method in Russia is unsafe intrauterine intravascular transfusion of donor red blood cells (IUTD) to the fetus, including repeated transfusions. In the country's leading clinics, even with multiple IUTDs, delivery to the fetus with severe HDP / HDN is always operative, occurring in 73% of cases between 32 and 36 weeks of pregnancy. With IVP, every second child is born with severe asphyxia (Apgar score 1-3 points), newborns undergo exchange blood transfusions (EBT) and simple blood transfusions in 78.9% and 26.3% of cases, respectively, only 80.9% of children survive (Saveleva G.M., Konoplyannikov A.G., Karaganova E.Ya. et al. Our experience of multiple intrauterine blood transfusions to a fetus with a severe form of hemolytic disease in rhesus incompatibility / / Obstetrics and Gynecology. No. 2 / 2022.-pp. 65-71).
[0004] The disadvantage of this method is unfavorable perinatal indicators (every fifth fetus-child dies) due to the lack of non-specific prevention, although it is well known from the literature that plasmapheresis in combination with other methods of blood purification from ETS and Rh antibodies can prevent the development of severe forms of GBP, reduce the need for PDE with improved outcomes for the fetus.
[0005] The closest method to the claimed method is the use of the method of hemosorption (HS) of the mother before and during PDE of the fetus in pregnant women with non-immune hydrops fetalis (NIHF) of infectious genesis (Eurasian patent No. 0473730).
[0006] A disadvantage of the prototype method is that during HS, protein molecules are deposited from the bloodstream onto the hemosorbent. This, combined with fluid retention in the fetal tissues and cavities, can exacerbate fetal edema and require additional treatment measures, such as oncotherapy and osmotherapy. The infectious origin of the disease requires massive, unsafe antibacterial therapy, which can reduce the resistance of the fetus, weakened by anemia and intoxication, to the invasive PDE procedure.
[0007] The objective of the invention is to relieve signs of anemia and fetal hydrops in cases of fetal insufficiency and Rhesus conflict while preserving the life of the fetus.
[0008] The technical result of the stated task is achieved by the fact that in the method for treating pregnant women with immune hydrops fetalis in case of Rhesus conflict, based on the transfusion of donor erythrocytes (DER) to the fetus, before the course of DER, the mother undergoes a session of membrane plasmapheresis (MPA) with the exfusion of plasma in a volume of 1% of the body weight, with photomodification of blood (PM) with ultraviolet rays at a wavelength of 365 nm, for plasma replacement in MPA, 200 ml of isolated, ultraviolet-irradiated autoplasma (AP) with Rh antibodies are used, the remaining AP is frozen for storage.
[0009] Performing a MPA and FC session at the beginning of treatment, instead of GS, ensures the removal of endogenous toxic substances and Rh antibodies from the interstitial system while maintaining the detoxifying effects and non-specific prevention of progressive fetal erythrocyte hemolysis. Conversely, the return of autoplasma containing Rh antibodies during treatment also promotes the specific prevention of immune hemolysis of fetal erythrocytes by suppressing the immune system's ability to produce new Rh antibodies. Other positive effects of AP return include an increase in oncotic pressure in the vessels of the interstitial system with the attraction of fluid from the interstitium and the well-known immunocorrective effect of autohemotherapy. These effects, together with the fetal PDE, generally enhance the therapeutic effect on the interstitial system, preventing the worsening of HDP / GBN and its edema syndrome without the need for intensive therapy or blood transfusions in the newborn, with favorable perinatal outcomes.
[0010] The method is carried out as follows. After confirming the presence of Rh-positive blood and anemia in the fetus, a pregnant woman with IVP, before a course of intrauterine PDE to the fetus, a session of medium-volume IPA is performed (App. "Hemos-PF", NPP "Biotech M", Moscow) with plasma exfusion in a volume of 1% of body weight (BW; for 60 kg - 600 ml, for 90 kg - 900 ml). Given the frequent presence of genital infections in pregnant women (Candida fungi, etc.), the isolated plasma is irradiated with ultraviolet rays on the app. "Matrix-Vlok" (OOO NIC "Matrix", Moscow) at a wavelength of 365 nm. For plasma replacement during MPA, isotonic sodium chloride solution, 200 ml of isolated, UV-irradiated plasma, and 200 ml of 10% glucose solution are used, in a total volume of 1% of the body weight. The remaining plasma is collected in equal parts in three Gemakon or Compoplast containers and frozen for future use at -30 degrees Celsius.These plasma fractions are defrosted and returned to the patient by passing them through a hemosorbent during hemosurgical procedures, which are performed the day after each fetal PDE.
[0011] If after such a course of treatment of three PDE operations on the fetus with ET and return of the AP to the mother, prolongation of pregnancy and continuation of PDE operations on the fetus are expected, then the above cycle is repeated.
[0012] Example. Patient B., 26 years old. Admitted to St. Petersburg State Pediatric Medical University on September 26, 2024, with the following diagnosis: 32 weeks pregnant. Rh-inconsistent pregnancy (Rh antibody titer 1:2048), severe HDP, immune hydrops fetalis. Chronic pyelonephritis, mild anemia, von Willebrand disease type 2.
[0013] The diagnosis of IVP was confirmed during examination. Treatment was performed according to the stated method. As a result of treatment, the fetus's manifestations of severe HDP and IVP were relieved. At 36 weeks, the patient delivered spontaneously through the vaginal canal. A live girl was born weighing 2410 g, measuring 49 cm in length, with an Apgar score of 7 / 8. The baby did not require intensive care, respiratory support, or blood transfusions. She was monitored in the neonatal pathology department from the fourth day of life, together with her mother. Hemolytic anemia and mild jaundice were noted; the baby received phototherapy and formula feeding (the mother's antibody titer was 1:1024). She was discharged home in satisfactory condition two weeks after birth.
[0014] The claimed method reduces the level of a woman's sensitization to the Rh factor based on antibody titers, alleviates endotoxicosis in the uterine tract, severe anemia, and fetal edema syndrome during prolonged pregnancy, with favorable outcomes for both mother and fetus. It helps increase fetal resistance to intrauterine implants (IUDs), is simple, safe, and accessible to every maternity facility.
Claims
A method for treating pregnant women with immune hydrops fetalis due to Rh-incompatibility, based on the transfusion of donor erythrocytes (DER) to the fetus, characterized in that before the course of DER, the mother undergoes a session of membrane plasmapheresis (MPA) with plasma exfusion in a volume of 1% of body weight, with blood photomodification (PM) using ultraviolet rays at a wavelength of 365 nm; for plasma replacement in MPA, 200 ml of isolated, ultraviolet-irradiated autoplasma (AP) with Rh-antibodies is used, the remaining AP is frozen for storage.