In the setting of postpartum care after vaginal delivery, rooming-in is associated with a higher rate of exclusive breastfeeding rate at hospital discharge, but there is insufficient evidence to support or refute rooming-in to increase breastfeeding at 6 months. Education and support for breastfeeding are valuable interventions to promote initiation of breastfeeding whether it is offered by a healthcare professional, nonhealthcare professional, or peer. A combined intervention, a professional provider-led intervention, having a protocol available for the provider training program, and implementation during both the prenatal and postnatal periods increased the rate of exclusive breastfeeding for 6 months. There is no single effective treatment for breast engorgement. Breast massage, continuing breastfeeding, and pain relief are recommended by national guidelines. Nonsteroidal anti-inflammatory drugs and acetaminophen are better than placebo for relief of pain caused by uterine cramping and perineal trauma; acetaminophen is effective in breastfeeding individuals who underwent episiotomy; and local cooling pain relievers have been shown to reduce perineal pain for 24 to 72 hours, compared with no treatment. There is insufficient evidence to assess the safety and efficacy of postpartum routine universal thromboprophylaxis after vaginal delivery. Anti-D immune globulin administration is recommended in Rhesus-negative individuals who have given birth to a Rhesus-positive infant. There is very low-quality evidence that a universal complete blood count is useful in reducing the risk of receiving blood products. In the absence of any postpartum complication, there is insufficient evidence to recommend a routine postpartum ultrasound. Measles, mumps, and rubella combination; varicella; human papillomavirus; and tetanus, diphtheria, and pertussis vaccines should be administered in nonimmune individuals in the postpartum period. Smallpox and yellow fever vaccines should be avoided. Individuals undergoing postplacental placement are more likely to use an intrauterine device at 6 months than those advised to follow-up for placement during outpatient postpartum care. An implant is safe and effective for immediate postpartum contraception. There is insufficient evidence to support or refute the routine administration of micronutrient supplements in breastfeeding women. Placentophagia does not provide any benefits and exposes mothers and offspring to infectious risks. Therefore, it should be discouraged. Because of the low level of evidence, there is insufficient data to assess the efficacy of home visits in the postpartum period. There is insufficient evidence to recommend when to resume daily activities, and individuals should be counseled to return to prepregnancy level of activity or exercise when comfortable. Sexual activity, housework exercise, driving, climbing stairs, and lifting weights should be resumed as soon as postpartum individuals want. A behavioral educational intervention reduces depression symptoms and increases breastfeeding duration. Physical activity after delivery is protective against postpartum mood disorders. There is no strong evidence that supports early discharge after vaginal delivery compared with standard discharge (ie, ≥48 hours).

2022-05-01·AJOG Global Reports

Missed anti-D immune globulin administration to postpartum patients in 2 health systems: an unrecognized patient safety risk

Article

作者: Brackney, Kerri ; Rincon, Monica ; Hersh, Alyssa ; Gibson, Kelly S ; Bar-Shain, David ; Labbad, Gabriel ; Babb, Ray

BACKGROUNDMaternal-fetal Rh-alloimmunization is a rare but potentially fatal event, most often caused by maternal exposure to D-antigen-presenting Rh-positive erythrocytes at the time of delivery. Prophylaxis with anti-D immune globulin is highly effective with a low side-effect profile and results in a dramatically decreased risk of alloimmunization. Postpartum anti-D immune globulin prophylaxis is recommended by national societies to reduce Rh-alloimmunization. We hypothesized that a small number of postpartum patients do not receive prophylaxis as indicated.  .OBJECTIVEWe investigated patients in 2 separate health systems that did not receive indicated prophylaxis and devised a suite of Electronic Health Record interventions to prevent future errors.STUDY DESIGNWe reviewed charts retrospectively from Electronic Health Record data of 2 urban academic health systems, the MetroHealth System and Oregon Health & Science University. We identified all Rh-negative postpartum patients and their infants delivering from 2014 to 2019. The primary outcome was the proportion of postpartum patients not receiving indicated anti-D immune globulin prophylaxis. Once cases of missed anti-D immune globulin prophylaxis were identified, we reviewed individual charts to determine the relevant clinical circumstances and potential causes for error.RESULTSOf 29,801 deliveries over 5 years (15,444 at MetroHealth System and 14,357 at Oregon Health & Science University), there were 3087 Rh-negative postpartum patients, of whom 7 were alloimmunized and ineligible for prophylaxis. Anti-D immune globulin was indicated for 2162 (70.0%) women as they delivered an Rh-positive infant. A total of 37 indicated patients did not receive postpartum anti-D immune globulin. Twenty patients were offered prophylaxis and declined. We missed a total of 17 opportunities, thus our institutions appropriately offered indicated anti-D prophylaxis to 99.2% of patients over a period of 5 years. Of the 17 true misses, anti-D immune globulin was ordered for some patients, whereas others did not have an anti-D immune globulin order placed. A toolkit in the Electronic Health Record consisting of decision-support hard stops, automated documentation, and longitudinal reporting was implemented at the MetroHealth System in the year after its inception. The Toolkit identified and helped prevent 4 potential misses, resulting in a 100% anti-D prophylaxis rate at the MetroHealth System.CONCLUSIONGiven the serious nature of Rh-alloimmunization, we believe missed prophylaxis should be a never event. Through examination of our current processes, we identified areas of improvement and developed a Postpartum Anti-D Immune Globulin Prophylaxis Electronic Health Record Toolkit, which showed improvement in administration rates. Such a toolkit has the potential to identify patients appropriately and avoid missed anti-D immune globulin prophylaxis events.

2021-12-15·Maedica - A Journal of Clinical Medicine

Prognosis and Management in Subsequent Rh Alloimmunized Pregnancies

作者: Peltecu, Gheorghe ; Dumitru, Andreea ; Gica, Nicolae ; Botezatu, Radu

Background: RhD alloimmunization remains a severe problem worldwide, but its management has been revolutionized by two important discoveries: the possibility to establish fetal Rh genotype non-invasively by using a maternal blood sample, and using of Doppler velocimetry to monitor early signs of affected fetuses. Materials and methods: We performed a literature review by searching PubMed for relevant information about diagnosis, prognosis, and management of secondary affected Rh alloimmunized pregnancies. Results:The risk to develop fetal anemia and hydrops seems to increase with increasing concentrations of Rh antibodies, and studies show it is higher for subsequent pregnancies. Individuals presenting the DEL phenotype with the types 1, 2 or 3 can be considered RhD positive and anti-D immune globulin is not indicated. Discussions: Medical algorithm involves previous pregnancy history together with serum parameters. Follow-up in a department of maternal fetal medicine is desired and encouraged in these cases. Depending on the severity and woman's previous pregnancy history, especially condition prior to 24 weeks of gestation, several therapies such as plasmaphereses, intravenous immune globulin or intrauterine transfusions can be conducted. Intrauterine transfusions have a better prognosis when performed earlier and on fetuses without hydrops. Conclusion:Although the incidence of hemolytic disease of the fetus and newborn has decreased and is no longer a major cause of perinatal mortality, vigilance is still required. There is a strong argument for reunite the management of these cases in dedicated maternal fetal medicine centers that perform invasive procedures in order to improve knowledge, gain skills and enhance clinical management.

项与干燥抗D(Rho)人免疫球蛋白(Takeda) 相关的新闻（医药）

2024-04-17

·PRNewswire

BILLIONTOONE MITIGATING RHOGAM(R) SHORTAGE WITH UNITY FETAL RhD™ NON-INVASIVE PRENATAL TEST

Groundbreaking Genetic Screening Test Has Helped Over 80,000 Pregnant Patients Determine Need for Anti-D Immune Globulin MENLO PARK, Calif., April 17, 2024 /PRNewswire/ -- BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, has reached a milestone of testing over 80,000 patients for Rh incompatibility, which develops when a pregnant patient has Rh-negative blood and the baby has Rh-positive blood. In rare cases this incompatibility can lead to a serious issue in which the pregnant patient's immune system will attack their baby's red blood cells as foreign. Currently, the protocol for managing this potential incompatibility for the 15% of pregnant patients who are Rh-negative is the administration of Anti-D Immune Globulin, an extremely effective intervention that significantly improved maternal and fetal care in the 20th century. However, the FDA recently announced that the most common brand of this medication, RhoGAM(R), is in shortage. While this treatment is necessary to prevent complications, it is only necessary if the baby's blood is Rh-positive. As a result, Anti-D Immune Globulin treatment is unnecessary for the 40% of pregnancies where the baby is Rh-negative. "Healthcare providers and blood banks across the U.S. are facing a unique challenge because of the RhoGAM(R) shortage, and it's important now that the healthcare industry works together to support the treatment of Rh sensitization and its implications. Utilizing cell-free DNA in maternal plasma, the UNITY Fetal RhD Non-Invasive Prenatal Test can determine fetal RhD status," said Jennifer Hoskovec, MS, Certified Genetic Counselor and Senior Director of Medical Affairs at BillionToOne. "We are grateful to have the opportunity to support patients in avoiding unnecessary treatments during their pregnancies and to save the reduced supply of RhoGAM(R) for the pregnant people who truly need it to safely address and treat differing Rh status." The UNITY Fetal RhD NIPT offers a reliable and convenient alternative to traditional methods of determining fetal RhD status, such as paternal testing and invasive procedures like amniocentesis. The UNITY Fetal RhD NIPT accurately determines the RhD status of the fetus from maternal blood as early as 10 weeks gestation. Recent data published in Scientific Reports demonstrated that the test has diagnostic-level accuracy with >99.9% sensitivity and specificity, and 100% concordance with newborn outcomes, including for the detection of RhD Psi and RhD-CE, which had been a challenge in other assays. A separate version of the assay has also been approved as a Clinical Trial Assay (CTA) by the FDA for use in a Phase III clinical trial in a global collaboration with Janssen Research & Development, LLC. In a separate study, this use case for alloimmunized pregnancies has also shown 100% accuracy with more than 500 newborn outcomes. Currently, when the gestating parent is tested to be Rh negative, Anti-D Immune Globulin is administered to any pregnant person on any subsequent pregnancy at 28 weeks. In the event that Rh incompatibility goes untreated, the parent's immune system sees the baby's red blood cells as "foreign" and will try to eliminate them as invaders by making anti-Rh antibodies. These antibodies can cross the placenta and attack the fetus's red blood cells, resulting in a variety of issues, including hemolytic disease of the fetus and newborn (HDFN), a condition in which the red blood cells of the fetus are destroyed by the mother's antibodies - creating serious complications for the baby. "The UNITY Fetal RhD NIPT is a reliable and convenient alternative to the traditional methods of determining fetal RhD status," said Dr. Nicole Plenty, Maternal-Fetal Medicine Division Director at Wellstar Health System. "This test's exceptional accuracy has enabled doctors to alleviate concerns and anxieties among expectant parents facing the uncertainty of RhD status in their pregnancies, particularly in the light of the national RhoGAM shortage. Due to confidence in the results of this test, physicians are able to dedicate resources like RhoGAM to patients who truly need them." About BillionToOne Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for all. The company's patented Quantitative Counting Technology™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, please visit For more information about the trial or the collaboration, please contact [[email protected]] SOURCE BillionToOne

临床3期临床结果上市批准

100 项与干燥抗D(Rho)人免疫球蛋白(Takeda) 相关的药物交易

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