The effectiveness of desogestrel for endometrial protection in women with abnormal uterine bleeding-ovulatory dysfunction: a non-inferiority randomized controlled trial
Scientific reports. 2022;12(1):1662
Women with chronic abnormal uterine bleeding-ovulatory dysfunction (AUB-O) are at increased risk of endometrial neoplasia. We conducted a non-inferiority randomized controlled trial to determine the effectiveness of two cyclic-progestin regimens orally administered 10 d/month for 6 months on endometrial protection and menstruation normalization in women with AUB-O. There were 104 premenopausal women with AUB-O randomized to desogestrel (DSG 150 µg/d, n = 50) or medroxyprogesterone acetate (MPA 10 mg/d, n = 54) group. Both groups were comparable in age (44.8 ± 5.7 vs. 42.5 ± 7.1 years), body mass index (24.8 ± 4.7 vs. 24.9 ± 4.7 kg/m(2)), and AUB characteristics (100% irregular periods). The primary outcome was endometrial response rate (the proportion of patients having complete pseudodecidualization in endometrial biopsies during treatment cycle-1). The secondary outcome was clinical response rate (the proportion of progestin withdrawal bleeding episodes with acceptable bleeding characteristics during treatment cycle-2 to cycle-6). DSG was not inferior to MPA regarding the endometrial protection (endometrial response rate of 78.0% vs. 70.4%, 95% CI of difference - 9.1-24.4%, non-inferiority limit of - 10%), but it was less effective regarding the menstruation normalization (acceptable bleeding rate of 90.0% vs 96.6%, P = 0.016).Clinical trial registration: ClinicalTrials.gov (NCT02103764, date of approval 18 Feb 2014).
Effects of Umbilical Cord Management Strategies on Stem Cell Transfusion, Delivery Room Adaptation, and Cerebral Oxygenation in Term and Late Preterm Infants
Frontiers in pediatrics. 2022;10:838444
BACKGROUND The umbilical cord blood contains a high concentration of stem cells. There is not any published study evaluating the amount of stem cells that have the potential to be transferred to the infant through placental transfusion methods as delayed cord clamping (DCC) and umbilical cord milking (UCM). The aim of this study is to measure the concentrations of endothelial progenitor cell (EPC) and CD34+ hematopoietic stem cell (HSC) in the placental residual blood volume (PRBV), and evaluate the delivery room adaptation and cerebral oxygenation of these infants. METHODS Infants with ≥36 gestational weeks were randomized to receive DCC (120 s), UCM, or immediate cord clamping (ICC). EPC and CD34+ HSC were measured by flow cytometry from the cord blood. PRBV was collected in the setup. The cord blood gas analysis and complete blood count were performed. The heart rate (HR), oxygen saturation (SpO2), and cerebral regional oxygen saturation (crSO2) were recorded. RESULTS A total of 103 infants were evaluated. The amount of PRBV (in ml and ml/kg) was higher in the ICC group (p < 0.001). The number of EPCs in the PRBV content (both ml and ml/kg) were the highest in the ICC group (p = 0.002 and p = 0.001, respectively). The number of CD34+ HSCs in PRBV content (ml and ml/kg) was similar in all groups, but nonsignificantly higher in the ICC group. The APGAR scores at the first and fifth min were lower in the ICC group (p < 0.05). The mean crSO2 values were higher at the 3rd and 10th min in the DCC group (p = 0.042 and p = 0.045, respectively). cFOE values were higher at the 3rd and 10th min in the ICC group (p = 0.011 and p < 0.001, respectively). CONCLUSION This study showed that placental transfusion methods, such as DCC and UCM, provide both higher blood volume, more stem cells transfer to the infant, and better cerebral oxygenation in the first minutes of life, whereas many lineages of stem cells is lost to the placenta by ICC with higher residual blood volume. These cord management methods rather than ICC do not require any cost or technology, and may be a preemptive therapeutic source for diseases of the neonatal period.
Effect of autologous platelet-rich plasma for treatment of recurrent pregnancy loss: a randomized controlled trial
Obstetrics & gynecology science. 2022
OBJECTIVE Recurrent pregnancy loss (RPL) is a fertility problem for which no exact mechanism of abortion or efficient treatment has been described. This study was conducted between 2018 and 2019 to investigate the effectiveness of autologous platelet-rich plasma (PRP) in improving the live birth rate of women with RPL who required in vitro fertilization (IVF). METHODS A total of 63 patients with at least two previous pregnancy losses and no specific cause detected for the RPL were included and randomly assigned into two groups (PRP and control). Intrauterine infusion of 0.5 mL of autologous PRP was performed 48 h before embryo transfer in the PRP group. Women in the control group received standard treatment. RESULTS Forty patients completed the study. The baseline and cycle characteristics of the participants did not differ significantly between the PRP and control groups. The clinical pregnancy rate was higher in the PRP group (35% vs. 20%, P=0.288). The live birth rate was 15% in the PRP group, but no live births were recorded in the control group (P=0.231). CONCLUSION This is the first study to show that intrauterine infusion of PRP in patients with RPL who undergo IVF may increase the chance of live birth.
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.
Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding
Introduction Heavy menstrual bleeding (HMB) is characterized by high blood loss (>80 mL per cycle) at regular menstrual intervals. It can have an impact on a woman's bodily, mental, and/or material well-being. The etiology is varied and can be local, systemic, or iatrogenic. The occurrence of HMB is between 4% and 27%, depending on objective menstrual bleeding measurements and on high estimates based on subjective bleeding measures. This study was conducted to assess the efficacy of oral tranexamic acid versus combined oral contraceptive (COC) pills in the management of excessive menstrual bleeding. Methodology A comparative study was conducted at the Obstetrics and Gynecology Department of Combined Military Hospital Peshawar, Pakistan, from October 2020 to March 2021. Women aged above 18 years who presented with heavy menstrual bleeding (HMB) were included in the study. The exclusion criteria included all women with contraindications to the use of tranexamic acid, such as lactating mothers, pregnancy, use of oral contraceptives or steroids, history of renal malfunction or stroke, family history of thromboembolic disease, and ovarian or endometrial carcinoma. Patients with diagnosed leiomyomas with a size between >1 and 10 cm were included in the study. Women were allocated randomly into group A who received oral tranexamic acid 3.9-4 g per day or group B who received oral COC pills containing a combination of ethinyl estradiol 30 μg and norgestrel 0.3 mg. The efficacy of treatment was considered successful if there was a mean reduction in menstrual blood loss that was significantly greater than the baseline values. Results There were 178 patients in total, with 89 patients in each group. It was found that both oral tranexamic acid and combined oral contraceptives were equally effective in reducing the mean blood loss among patients and there was no statistical difference observed between the two groups. Upon stratification, it was found that both treatment groups were highly effective in younger age groups. Similarly, there was no significant difference in efficacy with respect to diabetes mellitus or hypertension. However, in individuals with leiomyomas, efficacy was significantly higher in patients who were in group B (combined oral contraceptives) (p = 0.004), and 46.1% of women in group A and 60.6% of women in group B did not experience any discomfort. Conclusion The current study revealed that both oral tranexamic acid and COC pills were equally effective in reducing the mean blood loss among patients with HMB. It was further found that the efficacy of both therapies was significantly higher in younger age groups. The efficacy of therapy was significantly reduced with the increasing age of the patient. Moreover, it was found that patients with leiomyomas benefitted more significantly from COC pills. There were no severe adverse effects reported in the study. However, future researches can explore the long-term side effects of both therapies. In short, both therapies were comparable in terms of efficacy and safety. Heavy menstrual bleeding can negatively impact a woman, emotionally and physically. Therefore, it is encouraged that physicians use their expert judgment while prescribing either oral tranexamic acid or COC pills to patients with HMB.
Influence of nursing interventions in improving midwives' knowledge of misoprostol use in the management of postpartum haemorrhage at selected hospitals in Ondo State, Nigeria
The Pan African medical journal. 2021;40:238
INTRODUCTION despite large investments in maternal health services in the world, postpartum hemorrhage (PPH) remains a major cause of maternal mortality. Misoprostol is the most available, accessible, and affordable uterotonic agent in the management of the third stage of labor and has been found to be effective in PPH prevention in low-income countries. This study, therefore, assessed the influence of nursing interventions improving midwives´ awareness of misoprostol use in the management of PPH at selected health facilities. METHODS we conducted a quasi-experimental study in two secondary health institutions in Ondo State. A total of 68 midwives, who consented to participate, were randomly distributed into experimental and control groups respectively. A questionnaire was administered for obtaining information about participants´ knowledge and use of misoprostol in the management of PPH. Midwives in the intervention group were trained using the adapted Pathfinder International Teaching Package on the use of misoprostol in the management of PPH. Data were analyzed using descriptive and inferential statistics. RESULTS in the pre-intervention phase, the mean knowledge score of the control group was 7.55 ± 2.57 while that of the experimental group was 8.89 ± 2.57. There was a significant increase in the number of participants knowing the correct dose of misoprostol for the management of PPH after intervention (27.0% vs 81.1% p=0.01). After intervention, there was a significant increase (p=0.01) in knowledge of misoprostol use in the intervention group compared to the control group (14.73 ± 2.57 vs 8.89 ± 2.57). CONCLUSION misoprostol educational intervention was effective in improving knowledge and use of misoprostol. Hence, continuing educational units in hospitals should include periodic training of midwives on the use of misoprostol in PPH prevention.
The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis
BJOG : an international journal of obstetrics and gynaecology. 2021
OBJECTIVE To evaluate the costs and non-inferiority of a strategy starting with the LNG-IUS compared to endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). DESIGN Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. SETTING General practices and gynaecology departments in the Netherlands. POPULATION 270 women with HMB, aged ≥34 years old, without intracavitary pathology or future child wish. METHODS Randomisation to a strategy starting with the LNG-IUS (n=132) or EA (n=138). The incremental cost-effectiveness ratio (ICER) was estimated. MAIN OUTCOME MEASURES Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). RESULTS Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months mean PBAC-scores were 64.8 in the LNG-IUS group (N=115) and 14.2 in the EA group (N=132); difference 50.5 points (95% CI: 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (RR 0.93, 95% CI: 0.85-1.01). The ICER was €23 (95% CI: €5-€111) per PBAC-point. CONCLUSIONS A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept.
Efficacy of intrauterine Bakri balloon tamponade combined with ascending uterine artery ligation on postpartum hemorrhage
American journal of translational research. 2021;13(5):4995-5002
OBJECTIVE To observe the efficacy of intrauterine Bakri balloon tamponade (IBBT) combined with ascending uterine artery ligation (AUAL) in the treatment of postpartum hemorrhage (PPH) due to uterine inertia after cesarean section. METHODS A total of 92 patients with PPH due to uterine inertia after cesarean section were divided into a study group (n=46) and a control group (n=46) in accordance with the random number table. The control group was treated with IBBT alone, while the study group was treated with IBBT combined with AUAL. The clinical efficacies, hemorrhage, surgical duration, hospital stay, hemorrhage rate after removal of tamponade, recurrence rate of PPH, changes in coagulation function and quality of life were compared between the two groups. RESULTS The overall response rate (ORR) in the study group was 95.65%, remarkably higher than that of 80.43% in the control group (P < 0.05). The study group had a lesser amount of hemorrhage at 2 h and 24 h after surgery, a longer surgical duration, a shorter hospital stay, and lower hemorrhage rate after removal of tamponade and recurrence rate of PPH than the control group (P < 0.05). After treatment, prothrombin time, activated partial thromboplastin time and fibrinogen in the study group were markedly higher than those in the control group (P < 0.05). Compared with those before treatment, the scores of quality of life in the two groups were elevated at 3 months after treatment (P < 0.05), and the scores of quality of life in the study group were higher than those in the control group at 3 months after treatment (P < 0.05). CONCLUSION IBBT combined with AUAL can effectively alleviate hemorrhage and improve coagulation function and quality of life of patients with PPH due to uterine inertia after cesarean section, exhibiting a definite efficacy and a high safety profile.
Measurement of postpartum blood loss using a new two-set liquid collection bag for vaginal delivery: A prospective, randomized, case control study
BACKGROUND Postpartum hemorrhage (PPH) is a major obstetric complication, and the real-time measurement of blood loss is important in the management and treatment of PPH. We designed a new two-set liquid collection bag (TSLCB) for measuring postpartum blood loss in vaginal delivery. The aim of this study was to evaluate the effectiveness of the TSLCB in separating the blood from the amniotic fluid during vaginal delivery and in determining the accuracy of the measured postpartum blood loss. METHODS A prospective, randomized, case control study was conducted in the Women's Hospital, Zhejiang University School of Medicine, from March 2018 to April 2018. Sixty single pregnant women with spontaneous labor at 37-41 weeks without maternal complications were randomly divided into the experimental and control groups. The TSLCB was used to evaluate separately the amount of blood and amniotic fluid. For the control group, visual estimation and traditional plastic blood-collecting consumables were used to estimate the amount of postpartum blood loss. The measured blood loss between the two groups was compared, and the association of the measured blood loss with various clinical lab indices and vital signs was investigated. RESULTS The TSLCB (the experimental group) improved the detection of the measured blood loss compared with visual estimation and the traditional method (the control group) (P < .05). In the experimental group, correlation analysis showed that the measured blood loss at delivery and within 24 h of delivery was significantly associated with the decreased hemoglobin level, red blood cell count, and hematocrit level of patients (r = -0.574, -0.455, -0.437; r = 0.-595, -0.368, -0.374; P < .05). In the control group, only the measured blood loss within 24 h of delivery was associated with the decreased hemoglobin level (r = -0.395, P < .05). No blood transfusion and plasma expanders were required in the treatment of PPH for both groups. CONCLUSIONS The TSLCB can be used to accurately measure the postpartum blood loss in vaginal delivery by medical personnel.
Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids
Journal of women's health (2002). 2021
Objective: To assess outcomes of women with uterine fibroids (UFs) and heavy menstrual bleeding (HMB) treated with 300 mg elagolix twice daily plus add-back therapy (E2 1 mg/NETA 0.5 mg once daily) or placebo who were not considered responders in pooled analysis of two phase 3, 6-month randomized clinical trials (Elaris UF-1 and UF-2). Methods: Responders were defined as women who met both primary end point bleeding criteria (<80 mL menstrual blood loss [MBL] during the final month and ≥50% reduction in MBL from baseline to the final month) and either completed the study or discontinued due to predefined reasons. Thus, women termed nonresponders who were analyzed in this study who met neither or one bleeding end point or met both criteria but prematurely discontinued treatment because of adverse events, perceived lack of efficacy, or required surgical or interventional treatment for UFs were analyzed in this study. This post hoc analysis assessed mean changes from baseline in MBL, as well as adverse events. Results: Among 367 women receiving elagolix with add-back with observed data, 89 (24%) were not considered responders. Within this subset, 17 (19%) women met both bleeding criteria but prematurely discontinued treatment for the reasons mentioned above, while 23 (26%) met one bleeding criterion and 49 (55%) met neither bleeding criteria, regardless of discontinuation status. Among all nonresponders, a numerical trend toward greater mean reductions in MBL was observed in those receiving elagolix with add-back, compared with placebo group nonresponders. No differences in adverse events were observed between responders and nonresponders. Conclusion: Forty of 89 (45%) women with HMB and UFs who were classified as nonresponders in the UF-1 or UF-2 trials may have had a clinically meaningful response to elagolix with add-back therapy because they met at least one of the objective bleeding criteria. Clinical Trial Registration: Clinicaltrials.gov, NCT02654054 and NCT02691494. (NEJM 2020; 382:328-340) DOI: 10.1056/NEJMoa1904351.