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      Safety of herbal medicine in the postpartum period of a Korean Medicine hospital and postpartum care centre: protocol of a registry study (SAFEHERE-PC)

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          Abstract

          Introduction

          Herbal medicines (HMs) are commonly used during the postpartum period in South Korea. However, the safety concerns associated with these medicines remain unresolved. This study aims to establish a registry of patients receiving HM treatment during the postpartum period and collect clinical data on treatments and adverse reactions to build evidence evaluating the safety of HM use.

          Methods and analysis

          This study will use a prospective observational registry, including patients admitted to the obstetrics and gynaecology department of the Woosuk University Korean Medicine Hospital’s postpartum care centre. A total of 1000 eligible patients visiting the Korean medicine hospital to recover from various postchildbirth symptoms and opting for HM treatment will be enrolled in the registry. For safety assessment, demographic information, medical history, adverse events (AEs) and treatment details, including HM prescription and concomitant medication usage, will be collected throughout the patient’s hospitalisation period at the postpartum care centre for analysis. Adverse reactions will be monitored daily during hospitalisation, and collected AEs will be analysed for causality using the WHO Uppsala Monitoring Centre causality assessment and the Naranjo Algorithm Score.

          Ethics and dissemination

          This study was approved by the Institutional Review Board of Woosuk University Korean Medicine Medical Center (WSOH IRB H2311-03-01). The results will be published in peer-reviewed journals or disseminated through conference presentations.

          Trial registration number

          KCT0009060.

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          Most cited references43

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          Continuing education module: postpartum maternal health care in the United States: a critical review.

          Postpartum maternal health care is a neglected aspect of women's health care. This neglect is evident in the limited national health objectives and data related to maternal health. Missed opportunities for enhancing the health care of postpartum women occur in the scope of routine postpartum care. Differing perceptions of maternal needs between nurses and new mothers also contribute to inadequate health care. Therefore, collecting national data on postpartum maternal morbidity, reforming postpartum care policies, providing holistic and flexible maternal health care, encouraging family support and involvement in support groups, and initiating educational programs are recommended. Further research is needed on issues related to postpartum maternal health.
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            Chinese herbal medicine use in Taiwan during pregnancy and the postpartum period: a population-based cohort study.

            Using Chinese herbal medicines during pregnancy and postpartum is common in the Chinese community. The purpose of this current study is to explore the use of Chinese herbal medicines by women during pregnancy and postpartum in Taiwan. It is an on-going prospective longitudinal study design. We used multistage stratified systematic sampling to recruit 24,200 pairs, postpartum women and newborns, from the Taiwan national birth register in 2005. Subjects underwent a home interview 6 months after their deliveries between June 2005 and July 2006. A structured questionnaire was successfully administered to 87.8% of the sampled population. At least one Chinese herbal medicine was used by 33.6% and 87.7% of the interviewed subjects during pregnancy and the postpartum period, respectively. An-Tai-Yin, Pearl powder, and Huanglian were the most commonly used during pregnancy, while Shen-Hua-Tang and Suz-Wu-Tang were the most commonly used by postpartum women. Pregnant women aged 20-34, with high education, threatened abortion, chronic disease, and primipara appeared to use more Chinese herbal medicines than others in the sample. Postpartum women with high education, primipara, normal spontaneous delivery, and breastfeeding were found to use more Chinese herbal medicines; but women with pregnancy-related illness used less. Chinese herbal medicines are frequently used by women during pregnancy and the postpartum period in Taiwan and those with high education and primipara used more such herbs. Due to limited safety information on these herbs, we would advise caution regarding their use either during pregnancy or postpartum breastfeeding period. Moreover, it is important for nurses/midwifes enquiring about such habits, and providing the adequate education to women during prenatal and postpartum care to prevent potential side effects.
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              Physical health problems after childbirth and maternal depression at six to seven months postpartum.

              To investigate the relationship between maternal physical and emotional health problems six to nine months after childbirth. Statewide postal survey, incorporating the Edinburgh Postnatal Depression Scale, distributed to women six to seven months after childbirth, with telephone interview follow up of a sub-sample of participants at seven to nine months postpartum. The postal survey was distributed to all women who gave birth in a two-week period in Victoria, Australia in September 1993, except those who had a stillbirth or known neonatal death. Follow up interviews were conducted with respondents to the postal survey who provided contact details and expressed interest in participating in further research selected to recruit three groups of equivalent size according to scores on the Edinburgh Postnatal Depression Scale: a low scoring group ( or = 13). The response rate to the postal survey was 62.5% (n = 1,336). Respondents were representative of the total sample in terms of mode of delivery, parity and infant birthweight; young women, single women and women of non-English speaking background were under-represented. The participation rate in telephone follow up interviews was: 89.1% (n = 204), comprising 66 women with an Edinburgh Postnatal Depression Scale score of or =13. The point prevalence of depression at six to seven months postpartum was 16.9% (225/1,331, 95% CI 14.9-18.9%). Physical and related health problems associated with significantly increased odds of depression at six to seven months were: tiredness (OR 3.42 [2.2-5.3]); urinary incontinence (OR 2.23 [1.5-3.4]); back pain (OR 2.20 [1.6-3.0]); sexual problems (OR 2.16 [1.6-3.0]); more coughs, colds and minor illnesses than usual (OR 2.78 [1.9-4.1]); bowel problems (OR 1.93 [1.3-2.9]) and relationship difficulties (OR 3.88 [2.8-5.4]). At follow up, three physical health factors were associated with statistically significant linear trends with poorer levels of emotional wellbeing. These were: tiredness (chi2 for linear trend = 12.38, P < 0.001); urinary incontinence (chi2 for linear trend = 5.63, P = 0.02); and more minor illnesses than usual (chi2 for linear trend = 7.94, P = 0.005). The study confirms a link between maternal emotional wellbeing and physical health and recovery in the postnatal period and has important implications for clinical practice. Strategies for encouraging greater disclosure of physical and emotional health problems, assessment of the physical health of recent mothers presenting with depression, and emotional health of recent mothers presenting with other morbidity should be high priorities for all health professionals in contact with mothers in the year following childbirth.
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                Author and article information

                Contributors
                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2024
                24 August 2024
                : 14
                : 8
                : e086645
                Affiliations
                [1 ]Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [2 ]departmentObstetrics & Gynecology , Woosuk University , Jeonju, Republic of Korea
                [3 ]departmentNeuropsychiatry , Woosuk University , Jeonju, Republic of Korea
                Author notes

                None declared.

                EL and MJS contributed equally.

                Author information
                http://orcid.org/0000-0002-4607-1328
                http://orcid.org/0000-0003-3327-2515
                http://orcid.org/0000-0003-1892-8862
                http://orcid.org/0000-0001-5542-3850
                http://orcid.org/0000-0003-3431-1109
                http://orcid.org/0000-0002-9838-0253
                http://orcid.org/0009-0009-0618-780X
                http://orcid.org/0000-0003-3517-170X
                http://orcid.org/0000-0003-1701-9122
                Article
                bmjopen-2024-086645
                10.1136/bmjopen-2024-086645
                11344528
                d9c20112-c819-476e-94b9-708d0a0ebb68
                Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 19 March 2024
                : 09 August 2024
                Funding
                Funded by: The Ministry of Health & Welfare, Republic of Korea;
                Award ID: RS-2023-KH138688
                Categories
                Protocol
                Obstetrics and Gynaecology
                1845
                1506

                Medicine
                herbal medicine,adverse events,postpartum period,registries,safety
                Medicine
                herbal medicine, adverse events, postpartum period, registries, safety

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