Abstract

BACKGROUND Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. Ulipristal acetate is prescribed to treat symptoms associated with uterine fibroids. We compared the effectiveness of ulipristal acetate and the levonorgestrel-releasing intrauterine system at reducing the burden of heavy menstrual bleeding, irrespective of the presence of fibroids. METHODS This randomised, open-label, parallel group phase III trial enrolled women over 18 years with heavy menstrual bleeding from 10 UK hospitals. Participants were centrally randomised, in a 1:1 ratio, to either three, 12-week treatment cycles of 5 mg ulipristal acetate daily, separated by 4-week treatment-free intervals, or a levonorgestrel-releasing intrauterine system. The primary outcome, analysed by intention-to-treat, was quality of life measured by the Menorrhagia Multi-Attribute Scale at 12 months. Secondary outcomes included menstrual bleeding and liver function. The trial is registered with ISRCTN, 20426843. FINDINGS Between June 5th, 2015 and February 26th, 2020, 236 women were randomised, either side of a recruitment suspension due to concerns of ulipristal acetate hepatoxicity. Subsequent withdrawal of ulipristal acetate led to early cessation of recruitment but the trial continued in follow-up. The primary outcome substantially improved in both groups, and was 89, (interquartile range [IQR] 65 to 100, n = 53) and 94, (IQR 70 to 100, n = 50; adjusted odds ratio 0.55, 95% confidence interval [CI] 0.26-1.17; p = 0.12) in the ulipristal and levonorgestrel-releasing intrauterine system groups. Rates of amenorrhoea at 12 months were higher in those allocated ulipristal acetate compared to levonorgestrel-releasing intrauterine system (64% versus 25%, adjusted odds ratio 7.12, 95% CI 2.29-22.2). Other outcomes were similar between the two groups and there were no cases of endometrial malignancy or hepatotoxicity due to ulipristal acetate use. INTERPRETATION Our findings suggested that both treatments improved quality of life. Ulipristal was more effective at inducing amenorrhoea. Ulipristal has been demonstrated to be an effective medical therapeutic option but currently its use has restrictions and requires liver function monitoring. FUNDING UK Medical Research Council and National Institute of Health Research EME Programme (12/206/52).

Abstract

BACKGROUND Despite using a tourniquet to reduce bleeding during abdominal myomectomy, the procedure is still complicated by significant intraoperative bleeding. AIM: To determine whether misoprostol and tourniquet compared with tourniquet alone would significantly reduce bleeding during abdominal myomectomy at two tertiary hospitals in Enugu. MATERIALS AND METHODS This study is an open-label randomized controlled trial. A total of 126 consenting participants were recruited from women booked for abdominal myomectomy at the study centers over 7 months. They were randomized into groups A (vaginal misoprostol 400 μg) and B (no misoprostol) one hour before surgery. Intraoperatively, all participants had a tourniquet application. Intraoperative and postoperative blood loss was compared between the two groups. Descriptive and inferential analyses were carried out using IBM SPSS Version 22.0. A P- value of < 0.05 was considered statistically significant. RESULTS An intention-to-treat analysis was carried out. All 63 participants (100%) and 56 (90%) completed the study according to the protocol in groups A and B, respectively. Socio-demographic characteristics were not significantly different in both groups. The mean intraoperative blood loss in the "misoprostol group" (522.6 ± 127.91 ml) was significantly lower than in the "no-misoprostol group" (583.5 ± 186.20 ml), with P = 0.028. The difference in mean hemoglobin (g/dl) was lower in the "misoprostol group" than in the "no-misoprostol group" (1.3 ± 0.79 vs. 1.9 ± 0.89, P < 0.001). The mean 48 hours postoperative blood loss (ml) between the two groups was 323.8 ± 221.44 vs. 549.4 ± 519.72), with P = 0.001. CONCLUSION Among women receiving tourniquet during myomectomy in Enugu, the additional use of vaginal misoprostol 400 μg significantly reduced intraoperative blood loss.

Abstract

OBJECTIVE The aim of this study was to investigate the effects of uterine massage performed before placental delivery on the third stage of labor and postpartum hemorrhage after vaginal delivery. MATERIALS AND METHODS The study was designed as a prospective randomized controlled study. Between June 2018 and June 2019, 242 women who gave birth in Istanbul Kanuni Sultan Suleyman Training and Research Hospital were included in the study. The women were divided into two groups; group 1 received uterine massage after vaginal delivery before placental delivery (n: 128) and group 2 did not receive massage (n: 114). Demographic characteristics, delivery times of the baby and placenta, duration of uterine massage, amount of postpartum hemorrhage and postpartum hemoglobin values of both groups were recorded. RESULTS Baseline characteristics were similar in both groups. Placental output time after delivery was 8.3 ± 4.2 min in group 1 and 13.5 ± 6.3 min in group 2. The third stage of labor was significantly shorter in group 1 (p = 0.012). The amount of blood loss of 500 mL or more after delivery was higher in group 2 but not statistically different (p > 0.05). Hemoglobin value measured within 12-24 h after delivery was significantly lower in group 2 (hemoglobin < 8 g/dL after 12-24 h p = 0.003; hemoglobin < 10 g/dL after 12-24 h p = 0.001). Delta hb value was also significantly lower in group 2 (p = 0.03). With this result, it was determined that bleeding intense enough to require transfusion was more common in group 2. CONCLUSION In patients delivering vaginally, uterine massage before placental delivery shortens the placental delivery time and reduces postpartum hemorrhage. In addition to oxytocin and controlled cord traction to reduce postpartum blood loss, uterine massage should be routinely used in the active management of the third stage of labor. CLINICAL TRIALS NUMBER NCT03858569.

Abstract

BACKGROUND Abnormal uterine bleeding (AUB) that is any irregularity in menstrual cycles causes women to refer to clinics. This study aimed to compare the efficacy, safety, and complications of endometrial ablation by the thermal balloon (Cavaterm) method with the hysteroscopy loop resection method in the treatment of AUB. MATERIALS AND METHODS The present study is an open-label, randomized clinical trial that was performed in the two hospitals, Shahid Akbarabadi and Hazrat Rasoul Akram, of Tehran, Iran, from December 2019 to October 2020. Patients were randomly allocated to the two groups of interventions by a simple randomization method. The proportion of amenorrhea (as primary outcome) and consequent hysterectomy and patient satisfaction (as secondary outcomes) was assessed using the Chi-square test and independent t test. RESULTS There was no significant difference between the two groups in the baseline characteristics. The percentage of intervention failure was statistically higher in the hysteroscopy group (24%) in comparison with the Cavaterm group [8.2%, P=0.03, relative risk (RR)=1.63, 95% confidence interval (CI): 1.13-2.36]. Mean ± standard deviation of satisfaction based on the Likert score in the Cavaterm group and hysteroscopy group were 4.3 ± 1.21 and 3.7 ± 1.56, respectively, that showed a significant difference (P=0.04). Assessing the procedural complications, the rate of spotting, bloody discharge, and malodor discharge was significantly higher in the Cavaterm group. In contrast, postoperative dysmenorrhea is more common in the hysteroscopy group. CONCLUSION Cavaterm ablation is accompanied by a higher success rate of amenorrhea and patients' satisfaction than hysteroscopy ablation (registration number: IRCT20220210053986N1).

Abstract

Delayed cord clamping (DCC) at delivery has well-recognized benefits; however, current scientific guidelines lack uniformity in its definition. This parallel-group, three-arm assessor-blinded randomized controlled trial compared the effects of three different timings of DCC at 30, 60, and 120 s on venous hematocrit and serum ferritin levels in late preterm and term neonates not requiring resuscitation. Eligible newborns (n = 204) were randomized to DCC 30 (n = 65), DCC 60 (n = 70), and DCC 120 (n = 69) groups immediately after delivery. The primary outcome variable was venous hematocrit at 24 ± 2 h. Secondary outcome variables were respiratory support, axillary temperature, vital parameters, incidences of polycythemia, neonatal hyperbilirubinemia (NNH), need and duration of phototherapy, and postpartum hemorrhage (PPH). Additionally, serum ferritin levels, the incidence of iron deficiency, exclusive breastfeeding (EBF) rate, and anthropometric parameters were assessed during post-discharge follow-up at 12 ± 2 weeks. Over one-third of the included mothers were anemic. DCC 120 was associated with a significant increase in the mean hematocrit by 2%, incidence of polycythemia, and duration of phototherapy, compared to DCC30 and DCC60; though the incidence of NNH and need for phototherapy was similar. No other serious neonatal or maternal adverse events including PPH were observed. No significant difference was documented in serum ferritin, incidences of iron deficiency, and growth parameters at 3 months even in the presence of a high EBF rate. Conclusion: The standard recommendation of DCC at 30-60 s may be considered a safe and effective intervention in the busy settings of low-middle-income countries with a high prevalence of maternal anemia. Trial registration: Clinical trial registry of India (CTRI/2021/10/037070). What is Known: • The benefits of delayed cord clamping (DCC) makes it an increasingly well-accepted practice in the delivery room. • However, uncertainty continues regarding the optimal timing of clamping; this may be of concern both in the neonate and the mother. What is New: • DCC at 120 s led to higher hematocrit, polycythemia and longer duration of phototherapy, without any difference in serum ferritin, and incidence of iron deficiency. • DCC at 30-60 s may be considered a safe and effective intervention in LMICs.

Abstract

BACKGROUND The levonorgestrel intrauterine system and combined oral contraceptives are the two most commonly used non-surgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life. OBJECTIVE To compare the effectiveness of the 52-mg levonorgestrel intrauterine system to combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 months and 12 months post-treatment. STUDY DESIGN We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a non-structural cause of heavy menstrual bleeding. Eligible and consenting participants were randomized in a 1:1 ratio to receive a 52 mg levonorgestrel intrauterine system or a monophasic 30 or 35 mcg ethinyl-estradiol containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range 0-75), at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed effects regression. Twenty-four participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the LNG IUS and individuals treated with COCs at each follow-up timepoint. RESULTS Sixty-two individuals were randomized to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses. Nineteen (of the 29) received the levonorgestrel intrauterine system and 31(of the 33) received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar between study groups. Bleeding- quality of life increased in both study arms as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6 weeks follow-up. In the main intention to treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=-2.5, 95% CI -10.0 to +5.0) or 12 months (difference=-1.1, 95% CI -8.7 to +6.5). Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was seen in the levonorgestrel intrauterine system arm at 6 months post-treatment (difference= -7.0, 95% CI -13.8 to -0.2) but not at 12 months (difference=-4.8, 95% CI -11.8 to 2.3) when compared to the combined oral contraceptive arm. CONCLUSION No significant differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life.

Abstract

INTRODUCTION Literature supports numerous benefits of skin-to-skin contact for neonatal adaptation to extrauterine life and bonding/attachment, but few studies explore the effects of skin-to-skin contact on maternal outcomes. This review aims to map the evidence on skin-to-skin contact in the third stage of labor for postpartum hemorrhage prevention. METHODS Scoping review, which covered stages recommended by the Institute Joanna Briggs, including studies from the PubMed, EMBASE, CINAHL, LILACS, Web of Science, and Scopus databases, using the descriptors "Postpartum hemorrhage", "Labor stages, third", "Prevention" and "Kangaroo care/Skin-to-skin". RESULTS 100 publications on the subject found, 13 articles met the inclusion criteria, with 10,169 dyads were assessed in all studies. Publications from 2008 to 2021 were mostly written in English and designed as a randomized controlled trial. Skin-to-skin contact was effective and significant in: reducing the duration of the third stage of labor; placenta delivery; uterine contractility and physiological involution; absence of atony, decreasing blood loss with lower rates of erythrocyte and hemoglobin drop; reducing the need for synthetic oxytocin and/or ergometrine to control bleeding; and reducing changing pads per period and length of stay. DISCUSSION Skin-to-skin contact was considered an effective, low-cost, and safe strategy, with positive effects already established in the literature for infants and extremely favorable results in postpartum hemorrhage prevention cases, being highly recommended in assistance for the dyad. Open Science Framework Registry ( https://osf.io/n3685 ).

Abstract

BACKGROUND Many questions remain about the appropriate utilization of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that an early use of intrauterine balloon tamponade might be beneficial. OBJECTIVE To compare, in women with PPH after vaginal delivery refractory to first-line uterotonics, the impact of IUBT used in combination with second-line uterotonics versus IUBT used after the failure of second-line uterotonics on the rate of severe PPH. STUDY DESIGN This multicenter, randomized, controlled, parallel-group, nonblinded trial took place at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35-42 weeks of gestation. Inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonic (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb® balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the sulprostone infusion started, intrauterine tamponade by the ebb® balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥ 3 units of packed red blood cells or had a calculated peripartum blood loss > 1000 mL. Prespecified secondary outcomes were the proportions of each of the following groups of women: those with a calculated blood loss ≥ 1500 mL; any transfusion; an invasive procedure; and transferred to an intensive care unit. Analysis of the primary outcome with the triangular test took place sequentially throughout the trial period. RESULTS At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the two groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. Women's baseline characteristics were similar in both groups. Peripartum hematocrit change, needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 in the control group. The primary outcome occurred in 67.2% (131/195) of the study group and 74.3% (142/191) of the control group (RR, 0.90; 95% CI, 0.79-1.03). The groups did not differ significantly for rates of calculated peripartum blood loss ≥ 1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 (2.7%) women in the study group and none in the control group (P= .06). CONCLUSIONS The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after failure of second-line uterotonics and before recourse to invasive procedures.

Abstract

BACKGROUND Preterm infants often have long hospital stays and frequent blood tests; they often develop anemia requiring multiple blood transfusions. Placental transfusion via delayed cord clamping (DCC) or umbilical cord milking (UCM) helps increase blood volume. We hypothesized umbilical cord milking (UCM), together with DCC, would be superior in reducing blood transfusions. OBJECTIVES To compare the effects of DCC and DCC combined with UCM on hematologic outcomes among preterm infants. METHODS One hundred twenty singleton preterm infants born at 280/7- 336/7 weeks of gestation at Thammasat University Hospital were enrolled in an open-label, randomized, controlled trial. They were placed into three groups (1:1:1) by a block-of-three randomization: DCC for 45 s, DCC with UCM performed before clamping (DCM-B), and DCC with UCM performed after clamping (DCM-A). The primary outcomes were hematocrit levels and number of infants receiving blood transfusions during the first 28 days of life. Intraventricular hemorrhage (IVH) and necrotizing enterocolitis (NEC) were secondary outcomes. Analyses were performed with an intent-to-treat approach. RESULTS One hundred twenty preterm infants were randomized. There was no statistically significant difference in neonatal outcomes; hematocrit on admission 54.0 ± 5.5, 53.3 ± 6.0, and 54.3 ± 5.8 (p = 0.88), receiving blood transfusions 25%, 20%, and 12.5% (p = 0.24), incidence of NEC 7.5, 0 and 10% (p = 0.78) in the DCC, DCM-B and DCM-A groups, respectively. There were no preterm infants with severe IVH, polycythemia, maternal or neonatal death. CONCLUSION The placental transfusion techniques utilized, DCC and DCC combined with UCM, provided the same benefits for preterm infants born at GA 28 and 33 weeks in terms of reducing the need for RBC transfusions, severities of IVH and incidence of NEC without increasing comorbidity. TRIAL REGISTRATION TCTR20190131002 . Registered 31 January 2019-Retrospectively registered.

Abstract

OBJECTIVE Systematic evaluation of the efficacy and safety of robotic-assisted laparoscopic myomectomy (RALM) versus laparoscopic myomectomy (LM). METHODS PubMed, Embase, The Cochrane Library, and Web of Science database were searched by computer to seek relevant literature in order to compare the efficacy and safety of RALM with that of LM from the establishment of the databases to January 2023, and Review Manager 5.4 software was utilized to perform a meta-analysis on the literature. RESULTS A total of 15 retrospective clinical controlled studies were included. There exists a total of 45,702 patients, among 11,618 patients in the RALM group and the remaining 34,084 patients in the LM group. Meta-analysis results revealed that RALM was associated with lesser intraoperative bleeding (MD =  - 32.03, 95%CI - 57.24 to - 6.83, P = 0.01), lower incidence of blood transfusions (OR = 0.86, 95%CI 0.77 to 0.97, P = 0.01), shorter postoperative hospital stay (MD =  - 0.11, 95%CI - 0.21 to - 0.01, P = 0.03), fewer transitions to open stomach (OR = 0.82, 95%CI 0.73 to 0.92, P = 0.0006), and lower incidence of postoperative complications (OR = 0.58, 95%CI 0.40 to 0.86, P = 0.006) than LM, whereas LM is more advantageous in terms of operative time (MD = 38.61, 95%CI 19.36 to 57.86, P < 0.0001). There was no statistical difference between the two surgical methods in terms of maximum myoma diameter (MD = 0.26, 95%CI - 0.17 to 0.70, P = 0.24). CONCLUSION In the aspects of intraoperative bleeding, lower incidence of blood transfusions, postoperative hospital stay, transit open stomach rate, and postoperative complications, RALM has a unique advantage than that of LM, while LM has advantages over RALM in terms of operative time.