Gongning granules plus low dose hormone in pubertal functional uterine hemorrhage: Analysis of hemodynamics and clinical efficacy
Pakistan journal of pharmaceutical sciences. 2022;35(1(Special)):387-392
To evaluate the clinic)al effect of Gongning granules combined with low-dose hormone therapy in pubertal dysfunctional uterine bleeding (PDUB) and its effect on uterine hemodynamics. A total of 164 PDUB patients who were treated in the gynecological outpatient department of our hospital from December 2018 to June 2020 were randomized into study group and control group, with 82 cases each. The control group received estrogen progesterone, and the study group received Gongning granules plus. The clinical efficacy and uterine arterial hemodynamics were compared. The clinical efficacy of the study group was superior to the control group (91.46% vs. 76.83%, P<0.05). The study group yielded shorter bleeding control time and complete hemostasis time than the control group (P<0.05). The amount of menstrual bleeding and duration of menstruation in both groups decreased significantly with time and the study group was significantly lower than the control group (all P<0.05). The endometrial thickness in the study group was significantly thinner than the control group, and the maximum follicle diameter was significantly longer than that in the control group (all P<0.05). After treatment, the platelet count, hemoglobin level of peripheral blood, uterine arterial blood flow and mean flow velocity in the study group were significantly higher than those in the control group (all P<0.05). In addition, there was no significant difference in adverse drug reaction (ADR) between the two groups (P>0.05). In PDUB patients, Gongning granules plus low-dose hormone can significantly relieve bleeding symptoms, improve hemodynamic status and has good safety.
Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial
BACKGROUND There is no effective treatment for women with unexplained recurrent pregnancy loss (RPL). We aimed to investigate whether treatment with a high dose of intravenous immunoglobulin (IVIG) in early pregnancy can improve pregnancy outcomes in women with unexplained RPL. METHODS In a double-blind, randomised, placebo-controlled trial, women with primary RPL of unexplained aetiology received 400 mg/kg of IVIG daily or placebo for five consecutive days starting at 4-6 weeks of gestation. They had experienced four or more miscarriages except biochemical pregnancy loss and at least one miscarriage of normal chromosome karyotype. The primary outcome was ongoing pregnancy rate at 22 weeks of gestation, and the live birth rate was the secondary outcome. We analysed all women receiving the study drug (intention-to-treat, ITT) and women except those who miscarried due to fetal chromosome abnormality (modified-ITT). This study is registered with ClinicalTrials.gov number, NCT02184741. FINDINGS From June 3, 2014 to Jan 29, 2020, 102 women were randomly assigned to receive IVIG (n = 53) or placebo (n = 49). Three women were excluded; therefore 50 women received IVIG and 49 women received placebo in the ITT population. The ongoing pregnancy rate at 22 weeks of gestation (31/50 [62·0%] vs. 17/49 [34·7%]; odds ratio [OR] 3·07, 95% CI 1·35-6·97; p = 0·009) and the live birth rate (29/50 [58·0%] vs. 17/49 [34·7%]; OR 2·60, 95% CI 1·15-5·86; p = 0·03) in the IVIG group were higher than those in the placebo group in the ITT population. The ongoing pregnancy rate at 22 weeks of gestation (OR 6·27, 95% CI 2·21-17·78; p < 0·001) and the live birth rate (OR 4·85, 95% CI 1·74-13·49; p = 0·003) significantly increased in women who received IVIG at 4-5 weeks of gestation as compared with placebo, but these increases were not evident in women who received IVIG at 6 weeks of gestation. Four newborns in the IVIG group and none in the placebo group had congenital anomalies (p = 0·28). INTERPRETATION A high dose of IVIG in very early pregnancy improved pregnancy outcome in women with four or more RPLs of unexplained aetiology. FUNDING The Japan Blood Products Organization.
The effect of preoperative oral carbohydrate on the time to colostrum and amount of vaginal bleeding after elective cesarean section
The journal of obstetrics and gynaecology research. 2022
OBJECTIVE To investigate the effect of oral carbohydrate at 2 h before elective cesarean section on postoperative recovery indicators such as the time to colostrum and vaginal bleeding. METHODS Women undergoing elective cesarean section under spinal-epidural anesthesia, aged 20-40 years, with a body mass index (BMI) of 19-30 kg/m(2) and an American Society of Anesthesiology (ASA) score of II were randomized to the oral carbohydrate group (the OC group), the oral placebo group (the OP group), or the control group (the C group). The OC group underwent oral carbohydrate preloading (300 mL/bottle), the OP group orally consumed 300 mL of distilled water, and the C group was forbidden from drinking or eating on the day of the operation. The time to colostrum, vaginal bleeding, time to exhaust, and complications were recorded. RESULTS A total of 38 participants in the OC group, 37 in the OP group, and 37 in the C group completed the study. Compared with the OP group and the C group, the OC group produced colostrum significantly earlier, had a lower amount of 24-h vaginal bleeding, and had a higher 24-h consumption of analgesics. Compared with OP and OC groups, the C group took longer to exhaust. No significant intergroup difference was observed for any other indicator. CONCLUSION Oral carbohydrates loading 2 h before elective cesarean section significantly reduces the time to produce colostrum and the amount of vaginal bleeding, which contributes to postoperative recovery.
Effects of Skin-to-Skin Contact on Afterpain and Postpartum Hemorrhage: A Randomized-Controlled Trial
Nursing & health sciences. 2022
This study determined the effects of skin-to-skin contact between the mother and the infant during the third stage of labor on postpartum hemorrhage and pain. This assessor-blinded randomized controlled trial was conducted with primiparous women. Skin-to-skin contact interventions between the infants and their mothers occurred for 30 min after birth (n:34), whereas the infants in the control group were provided routine care (n:34). Data were gathered using a Personal Information Form, the Visual Analog Scale-Pain, postpartum bleeding follow-up bags and records of blood oxytocin and beta-endorphin levels. There was no significant difference in beta endorphin levels in both groups (p: 0.771), whereas it was determined that the 30th min oxytocin level was significantly higher in the intervention group (Intervention group:225,81±256,87; Control group:152,76±181,70; p: 0.043). The Visual Analog Scale-Pain score at the postpartum 6th hour was significantly lower in the intervention group (Intervention group:1,56±0,96; Control group:2,92±1,89; p: 0.024). It was found that skin-to-skin contact made at the 3rd stage of labor reduced the amount of postpartum hemorrhage (p: 0.041). The results of this study suggested that skin-to-skin contact intervention may have beneficial effects on postpartum pain and postpartum hemorrhage in the early postpartum period. This article is protected by copyright. All rights reserved.
Bleeding profile of women with cardiovascular risk factors using a drospirenone only pill with 4 mg over nine cycles compared to desogestrel 0.075 mg
Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology. 2022;:1-6
OBJECTIVE Progestin-only pills are associated with irregular bleeding patterns, including amenorrhea. Desogestrel (DSG) 75 mcg, a pill that inhibits ovulation, shows poor cycle control that may harm acceptability and compliance. A Drospirenone (DRSP)-only pill was developed with 24 & 4 days of active & placebo days every 28-day cycle to improve cycle control. STUDY DESIGN A phase III study in healthy women aged 18 to 45 years was performed to compare the bleeding profile of women taking a DRSP versus DSG over nine cycles. 249 women were older > 35 years: 173 using DRSP and 73 DSG. 259 women had a BMI > 25 kg/m(2): 189 using DRSP and 70 DSG and 340 women were smokers: 237 using DRSP and 103 DSG. The amount of unscheduled bleeding/spotting days was analyzed in each of these sub-groups and compared statistically. RESULTS Age: During cycles 2-4, the mean number of unscheduled bleeding days and spotting was 8.1 (SD10.53) for DRSP and 20.1 (19.41) for DSG; p = .0089. BMI > 25 kg/m(2): During cycles 2-4 the mean number of unscheduled bleeding days and spotting was 7.8 (SD 12.18) for DRSP and 17.7 for DSG (SD 19.39); p = .0001. Smokers: During cycles 2-4, the mean number of unscheduled bleeding days and spotting was 9.6 (SD 11.69) for DRSP and 17.4 for DSG (SD 17.47); p = .0016. CONCLUSIONS These analyses show the improvement in the bleeding profile of women with specific cardiovascular risk factors using the DRSP only oral contraceptive product compared to DSG.ImplicationsAn improvement in the bleeding profile of women with specific cardiovascular risk factors like age > 35 years, BMI > 25kg/m(2), and smokers using the DRSP only oral contraceptive product is described.Herby a higher contraceptive efficacy in these patients that additionally benefit from estrogen-free contraceptive methods is expected.
[Multicenter, Randomized, Double-Blind, and Positive Drug-Controlled Clinical Trial on Prevention of Postpartum Hemorrhage after Vaginal Delivery with Ergometrine Maleate]
Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition. 2022;53(2):316-320
OBJECTIVE To evaluate the safety and efficacy of using ergometrine maleate injection combined with oxytocin injection, with oxytocin injection as the control, to prevent postpartum hemorrhage after vaginal delivery. METHODS A total of 305 cases who underwent vaginal delivery between December 2018 and November 2019 in 16 hospitals across China were enrolled and included in the full analysis set (FAS) and the safety analysis set (SS). Among the 299 subjects who completed the trial, 277 were included in the per protocol set (PPS). The subjects were randomly assigned by 1∶1 ratio to two groups, 152 cases in Group A, the experimental group receiving oxytocin injection plus ergometrine injection, and 153 cases in Group B, the control group, receiving oxytocin injection. The difference in total bleeding volume at 2 h, 6 h and 24 h postpartum in the two groups was documented and compared. Other measures were also compared between the two groups, including the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum, the proportion of subjects needing blood transfusion, the time of placenta retention, proportion of subjects with prolonged hospital stay due to uterine asthenia, the vital signs, lab test indicators and the incidence of adverse reactions in the two groups. RESULTS The total bleeding volume at 2 h, 6 h and 24 h after delivery was significantly lower in the experimental group (P<0.05). There was no significant difference between the two groups in the proportion of additional use of uterotonics and hemostatic drugs or other hemostatic measures 2 h and 24 h postpartum, the proportion of subjects needing blood transfusion and the time of placenta retention, heart rate, respiration, lab test indicators, or the incidence of adverse reaction (P>0.05). CONCLUSION Ergometrine maleate injection showed evident therapeutic efficacy in preventing hemorrhage after vaginal delivery, causing fewer adverse reactions and ensuring greater safety, and therefore, presenting promising prospects for clinical application.
Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial
BMC pregnancy and childbirth. 2022;22(1):178
BACKGROUND Postpartum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide. Tranexamic acid (TXA) is a useful drug for prevention of PPH and merits evaluation in Nigeria, where PPH is the leading cause of maternal death (25%) and severe maternal morbidity. This study evaluates the efficacy of TXA in reducing blood loss following vaginal delivery. METHODS This was a double-blind randomized placebo-controlled study on the efficacy and safety of intravenous TXA in reducing blood loss in women undergoing vaginal delivery in a tertiary hospital. Data analysis was conducted with IBM SPSS software (version 20, Chicago II, USA). P-value < 0.05 was considered statistically significant. RESULTS The mean estimated blood loss was lower in TXA compared with the placebo group. (174.87 ± 119.83 ml versus 341.07 ± 67.97 ml respectively; P < 0.0001). PPH (blood loss > 500 ml) was 5.13% in the study arm compared to the control arm 7.14%- risk ratio (RR) 0.71; 95% CI: 0.38-1.79, p = 0.5956]. Additional uterotonics was required more in the control group compared to the treatment group 14(16.67%) versus 3(3.85%), p-value= 0.007. There were no major complications noticed in the treatment group. CONCLUSION This study demonstrated that intravenous administration of TXA reduced blood loss following vaginal delivery. It also reduced the need for additional uterotonics. However, blood loss greater than 500 was not significantly reduced. TRIAL REGISTRATION This trial was registered retrospectively. Pan African Clinical Trial Registry: PACTR202010828881019 on 12/10/2020.
The Effect of Lipofilling and Platelet-Rich Plasma on Patients with Moderate-Severe Vulvar Lichen Sclerosus who were Non-Responders to Topical Clobetasol Propionate: A Randomized Pilot Study
Aesthetic plastic surgery. 2022
BACKGROUND The first-line treatment for vulvar lichen sclerosus (VLS) is 3 months of topical corticosteroid therapy. However, limited evidence is available concerning the use of fat grafting and platelet-rich plasma as a second-line treatment for patients who do not respond to first-line treatment. METHODS This prospective single-center randomized pilot trial included 20 patients with a clinical and histological diagnosis of moderate to severe VLS. The patients in the treatment group (TG) received two infiltrations (at 3-month intervals) of nanofat mixed with platelet-rich plasma (PRP) into the vulvar area, while the control group (CG) received standard topical corticosteroid therapy. Fat was aspirated from the medial thigh or lower abdomen regions. Microfat was obtained after centrifugation and was emulsified to obtain a nanofat suspension. Treatment efficacy was determined by measuring changes in the vulvar skin elasticity, histopathology, and clinical signs, symptoms, and patient quality of life at after 1 year. RESULTS A total of 19 patients were finally assessed (9 TG and 10 CG). At the end of the study (1 year), there had been no significant improvement in vulvar skin elasticity. However, patients in the TG showed a significant improvement in their symptoms (itching, pain, burning, and dyspareunia) and clinical signs (cervical erosions, fissures, stenosis, and leukoderma). Analysis of skin biopsies revealed a significant decrease in all inflammatory cell types in the TG. No adverse events related to the autologous treatment were recorded. CONCLUSIONS Compared with topical corticosteroids, two infiltrations delivered 3 months apart decreased the inflammation of the vulva and improved most of the clinical signs and symptoms associated with VLS. Nonetheless, no improvement in vulvar skin elasticity was derived from the autologous treatment. LEVEL OF EVIDENCE I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Evaluation of the effect of intrauterine injection of platelet-rich plasma on the pregnancy rate of patients with a history of implantation failure in the in vitro fertilization cycle
Journal of family medicine and primary care. 2022;11(5):2162-2166
OBJECTIVES Implantation failure is a major problem in reproductive medicine, and despite the various methods described for treatment, there is little consensus on the most effective method. This study was conducted to investigate the effect of intrauterine injection of platelet-rich plasma (PRP) on the pregnancy rate of patients with a history of implantation failure in the in vitro fertilization (IVF) cycle. STUDY DESIGN In this study, women attending the infertility clinic of Ali ibn Abi Taleb Hospital, who had a history of implantation failure and were candidates for frozen embryo transfer (FET), were examined in Zahedan (Iran) in 2019. The patients were divided into two groups of PRP recipients and the control group. IVF was performed routinely, and in the PRP-receiving group, an intrauterine injection was given 48 h before embryo transfer (ET). The number of gestational sacs, the rate of implantation, the frequency of chemical and clinical pregnancies as well as the frequency of abortion were compared in the two groups. The collected data were analyzed by the SPSS software version 21. RESULTS Ninety patients with a history of implantation failure participated in the study, and finally, the information of 85 patients was studied. The frequency of chemical pregnancy was 40% in the experimental group, 27% in the control group, and regarding clinical pregnancy, 33% in the experimental group and 24% in the control group, but there was no significant difference between the two groups. The rate of implantation, the mean thickness of the endometrium, and the frequency of abortion did not differ significantly between the two groups. CONCLUSION In patients with endometrial thickness greater than 8 mm with a history of recurrent implantation failure, intrauterine injection of PRP had no effect on the fertility outcome.
The Effect of Oxytocin plus Carboprost Methylate in Preventing Postpartum Hemorrhage in High-Risk Pregnancy and Its Effect on Blood Pressure
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:9878482
Objective. This study aimed to explore and analyze the effectiveness of oxytocin plus carboprost methylate in preventing postpartum hemorrhage in high-risk pregnancies and its effect on blood pressure. A total of 60 women with high-risk pregnancies who gave birth in our hospital from January 2020 to May 2021 were recruited and assigned via random number table method (1 : 1) to receive either oxytocin (control group) or oxytocin plus carboprost methylate (observation group). Outcome measures included hemorrhage and blood pressure. The bleeding volume of the women in the observation group (210.55 ± 45.98, 45.21 ± 9.27, and 73.74 ± 12.18) was significantly less than that in the control group during delivery and 2h and 24h after the delivery (276.91 ± 49.21, 72.98 ± 19.68, and 92.61 ± 15.67) (all P < 0.05). The observation group showed a significantly lower bleeding rate (6.67%) than the control group (16.67%) (P < 0.05). The two groups showed similar diastolic and systolic blood pressures (P > 0.05). Oxytocin plus carboprost methylate suppository effectively prevents postpartum hemorrhage in high-risk pregnancies, significantly reduces the amount of postpartum hemorrhage in high-risk pregnancies, and has little effect on the blood pressure of patients. Given its favorable treatment efficiency and high safety profile, this treatment protocol shows great potential for clinical application.