-
1.
Cut umbilical cord milking (C-UCM) as a mode of placental transfusion in non-vigorous preterm neonates: a randomized controlled trial
Bora, R. L., Bandyopadhyay, S., Saha, B., Mukherjee, S., Hazra, A.
European journal of pediatrics. 2023
Abstract
Routine practice of delayed cord clamping (DCC) is the standard of care in vigorous neonates. However there is no consensus on the recommended approach to placental transfusion in non-vigorous neonates. In this trial, we tried to examine the effect of cut umbilical cord milking (C-UCM) as compared to early cord clamping (ECC) on hematological and clinical hemodynamic parameters in non-vigorous preterm neonates of 30-35 weeks gestation. The primary outcome assessed was venous hematocrit (Hct) at 48 (± 4) hours of postnatal age. The important secondary outcomes assessed were serum ferritin at 6 weeks of age, mean blood pressure in the initial transitional phase along with important neonatal morbidities and potential complications. In this single centre randomized controlled trial, 134 non vigorous neonates of 30-35 weeks gestation were allocated in a 1:1 ratio to either C-UCM (n = 67) or ECC (n = 67). For statistical analysis, unpaired Student t and Chi square or Fisher's exact test were used. The mean Hct at 48 h was higher in the C-UCM group as compared to the control group, 50.24(4.200) vs 46.16(2.957), p < .0001. Also significantly higher was the mean Hct at 12 h, 6 weeks and mean serum ferritin at 6 weeks of age in the milked group (p < .0001). Mean blood pressure at 1 h and 6 h was also significantly higher in the milked arm. Need for transfusion and inotropes was less in the milked group but not statistically significant. No significant difference in potential complications was observed between the groups. Conclusion: C-UCM stabilizes initial blood pressure and results in higher hematocrit and improved iron stores. It can be an alternative to DCC in non-vigorous preterm neonates of 30-35 weeks' gestation. Further large multicentric studies are needed to fully establish its efficacy and safety. Trial registration: CTRI/2021/12/038606; registration date December 14, 2021. What is Known: • DCC is the routinely recommended method of placental transfusion for vigorous neonates but no consensus exist for neonates requiring resuscitation at birth. • C-UCM is easier to perform in non-vigorous neonates but there is paucity of studies in the preterm population. What is New: • C-UCM is effective as well as safe in non-vigorous preterm neonates of 30-35 weeks gestational age. • C-UCM holds promise as an alternative to DCC, especially in resource limited settings and in situations where the later is not feasible.
-
2.
Placental cord drainage vs delayed cord clamping at elective caesarean section: A randomised controlled trial
Fahy, M. J., Ko, C., Maynard, M., Kalian, K. N.
The Australian & New Zealand journal of obstetrics & gynaecology. 2023
Abstract
BACKGROUND Placental cord drainage (PCD) after vaginal birth accelerates placental delivery by 2.85 minutes, but reduces blood loss by only 77 mL. AIMS To determine if PCD at elective caesarean section accelerates placental delivery, compared to delayed cord clamping (DCC). MATERIALS AND METHODS This randomised controlled trial randomised 100 women undergoing elective caesarean sections to receive either PCD for 60 sec after birth, or DCC for 60 sec. The primary outcome was time from birth until placental delivery. Secondary outcomes included estimated blood loss (EBL), postoperative haemoglobin drop, rates of postpartum haemorrhage (PPH), manual removal of placenta and blood transfusion. RESULTS There was no significant difference in timing of placental delivery (PCD 122 sec vs DCC 123.5 sec, P = 0.717). There were no significant differences in EBL (PCD 425 mL vs DCC 400 mL, P = 0.858), postoperative haemoglobin drop (PCD 12 g/L vs DCC 15 g/L, P = 0.297), PPH rate (PCD 45.8% vs DCC 44.4%, P = 0.893, relative risk (RR) 1.03, 95% confidence interval (CI) 0.66-1.62), manual removal rate (PCD 2.1% vs DCC 4.4%, P = 0.609, RR 0.47, 95% CI 0.04-4.99) or transfusion rate (PCD 4.2% vs DCC 0%, P = 0.495). CONCLUSIONS PCD did not accelerate placental delivery at caesarean compared with DCC. Given that both PCD and DCC groups had faster placental deliveries than quoted in the literature at caesarean (200 sec), it could be postulated that DCC is mimicking the effect of PCD through passive transfusion to the neonate. This supports routine use of DCC at elective caesarean section.
-
3.
Utilization of non-pneumatic anti-shock garment for treating obstetric hemorrhage and associated factors among obstetric care providers in Ethiopia: A systematic review and meta-analysis
Addisu, D., Gebeyehu, N. A., Belachew, Y. Y., Mekie, M.
PloS one. 2023;18(11):e0294052
Abstract
BACKGROUND The non-pneumatic anti-shock garment (NASG) is a life-saving device that can help to avoid delays and prevent further complications in the case of obstetric hemorrhage. Although there are many fragmented primary studies on the NASG utilization in Ethiopia, the pooled utilization rate is unknown. In addition, a disagreement was observed among those studies while reporting the associated factors. Therefore, this study was intended to determine the pooled level of NASG utilization and its associated factors among obstetric care providers in Ethiopia. METHODS A total of 51 studies were retrieved from PubMed, Google Scholar, the African Journal of Online, direct open-access journals, and Ethiopian universities' institutional repositories. This study was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The quality of studies was evaluated using the modified Newcastle-Ottawa quality assessment tool. The data were extracted by two authors independently using Microsoft Excel and analyzed by Stata version 11. A random-effects model was applied to calculate the pooled level of NASG utilization and its associated factors. The PROSPERO registration number for the review is CRD42023414043. RESULT A total of 8 studies comprising 2,575 study participants were involved in this meta-analysis. The pooled utilization rate of NASG was found to be 39.56%. Having NASG training (pooled odds ratio (OR) = 3.99, 95%CI = 2.35, 6.77), good knowledge about NASG (OR = 2.92, 95%CI = 2.04, 4.17), a positive attitude towards NASG (OR = 3.17, 95%CI = 2.10, 4.79), and having ≥ 2 NASGs in the health facility (OR = 10.59, 95%CI = 6.59, 17.01) were significantly associated with NASG utilization. CONCLUSION Utilization of NASG for the treatment of obstetric hemorrhage was low in Ethiopia. To increase its utilization, Ministry of Health should improve the accessibility of NASG at each health facility and increase the Health professionals' knowledge and attitude through in-service and pre-service training.
-
4.
A randomized trial comparing the 52-mg levonorgestrel system to combination oral contraceptives for treatment of heavy menstrual bleeding
Matteson, K. A., Valcin, J., Raker, C. A., Clark, M. A.
American journal of obstetrics and gynecology. 2023
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.
-
5.
Effects of delayed cord clamping at different time intervals in late preterm and term neonates: a randomized controlled trial
Chaudhary, P., Priyadarshi, M., Singh, P., Chaurasia, S., Chaturvedi, J., Basu, S.
European journal of pediatrics. 2023;:1-11
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.
-
6.
Timing of umbilical cord occlusion, delayed vs early, in preterm babies: A randomized controlled trial (CODE-P Trial)
Gregoraci, A., Carbonell, M., Linde, A., Goya, M., Maiz, N., Gabriel, P., Villena, Y., Bérgamo, S., Beneitez, D., Montserrat, I., et al
European journal of obstetrics, gynecology, and reproductive biology. 2023;289:203-207
Abstract
INTRODUCTION Our hypothesis was that delayed cord clamping (DCC) (not earlier than 30 s; at 30-60 s) in premature neonates (born between 26.0 and 32.6 weeks of gestation), as compared with the usual early cord clamping (ECC), significantly reduces the need for blood transfusions and incidence of intraventricular haemorrhage (IVH) without an increased rate of maternal postpartum haemorrhage. MATERIAL AND METHODS A prospective, open-label, randomized, controlled trial was conducted at Vall d'Hebron Hospital from July 2014 to December 2018. All pregnant women at risk of impending preterm birth (≥26.0-<33.0 weeks of gestation) who were admitted to the obstetrics emergency department were evaluated for eligibility. If they met the eligibility criteria, they were invited to participate in the study and, if they agreed, they signed an informed consent. Patients were randomly assigned to one of two groups: ECC group and DCC group. RESULTS Our study included a total of 57 patients: 30 in the ECC group and 27 in the DCC group. Due to a lack of funding and low recruitment rates, the study was discontinued in 2018. Maternal characteristics and obstetric outcomes were similar between both groups. The intention-to-treat analysis did not reveal any differences between groups for neonatal red blood cell transfusions, neonatal IVH or maternal postpartum haemorrhage. There were no differences for secondary outcomes. Similarly, no differences were observed in the as-treated analysis. CONCLUSION The primary and secondary outcomes of our study were not achieved. Therefore, more meta-analysis and trials are needed to evaluate the appropriate timing of cord clamping in preterm birth.
-
7.
The impact of the Safe Delivery Application on knowledge and skills managing postpartum haemorrhage in a low resource setting: a cluster randomized controlled trial in West Wollega region, Ethiopia
Christiansen, A. H., Sørensen, B. L., Boas, I. M., Bedesa, T., Fekede, W., Nielsen, H. S., Lund, S.
Reproductive health. 2023;20(1):91
-
-
-
Free full text
-
Editor's Choice
Abstract
BACKGROUND Postpartum haemorrhage is one of the leading causes of maternal mortality in low-income countries. Improving health workers' competencies in obstetric emergencies in low-income settings, has been recognized as an important factor in preventing maternal mortality and morbidity. mHealth interventions in maternal and newborn health care has shown the potential to improve health service delivery. Strong study designs such as randomized controlled trials are missing to estimate the effectiveness of the mHealth interventions. METHODS Between August 2013 and August 2014, 70 health facilities in West Wollega Region, Ethiopia were included and randomized to intervention or control in a cluster randomized controlled trial. At intervention facilities birth attendants were provided with a smartphone with the SDA installed. Of 176 midwives and "health extension workers," 130 completed at 12 months follow-up. At baseline and after 6- and 12-months participants were assessed. Knowledge was tested by a Key Feature Questionnaire, skills by an Objective Structured Assessment of Technical Skills in a structured role-play scenario. RESULTS Baseline skills scores were low and comparable with a median of 12/100 in the intervention and the control group. After 6 months skills had doubled in the intervention group (adjusted mean difference 29.6; 95% CI 24.2-35.1 compared to 1·8; 95% CI - 2.7 to 6.3 in the control group). At 12 months skills had further improved in the intervention group (adjusted mean difference 13.3; 95% CI 8.3-18.3 compared to 3.1; 95% CI - 1.0 to 7.3 in the control group). Knowledge scores also significantly improved in the intervention group compared to the control (adjusted mean difference after 12 months 8.5; 95% CI 2.0-15.0). CONCLUSION The Safe Delivery App more than doubled clinical skills for managing postpartum haemorrhage among birth attendants making it an attractive tool to reduce maternal mortality. TRIAL REGISTRATION Clinicaltrial.gov Identifier NCT01945931. September 5, 2013. Maternal mortality caused by postpartum haemorrhage is a major public health concern in many low-income countries. Having access to skilled health care professionals during pregnancy and childbirth can prevent maternal deaths related to postpartum haemorrhage. mHealth interventions like the Safe Delivery App (SDA), a smartphone application, has shown the potential to improve the quality of care in emergency situations related to childbirth in low-income health system settings.This study examines the SDA as a training/education tool for improving health workers’ competencies and performances in managing postpartum haemorrhage. The SDA contained animated instruction videos on how to prevent and treat postpartum haemorrhage and a list of essential drugs and basic equipment.In Ethiopia, 70 health facilities and 176 birth attendants were included in a randomized controlled trial. The intervention group received a smartphone with the SDA installed and half a day of introduction to the use of the app. Birth attendants’ skills and knowledge in managing postpartum haemorrhage in the control and the intervention group were tested at baseline, 6 and 12 months after intervention.Our study found that the SDA is an effective tool to improve and sustain birth attendants’ knowledge and skills in the management of postpartum haemorrhage in a rural, low-resource health system setting in Ethiopia, which confirms findings in other non-randomized studies examining the SDA on the management of postpartum haemorrhage. eng
PICO Summary
Population
Midwives and health extension workers attending deliveries in 70 health facilities in Ethiopia (n= 176).
Intervention
Smartphone application ‘Safe Delivery App’ (SDA), (35 facilities, n= 87).
Comparison
No provision of the SDA (35 facilities, n= 89).
Outcome
The total scores in skills and knowledge tests for management of postpartum haemorrhage were the outcomes of this cluster randomised controlled trial. A total of 130 (74%) health workers completed the 6 and 12 months follow up, 65 in each arm, and were included in the analysis. Baseline skills scores were low and comparable with a median of 12/100 in the intervention and the control group. After 6 months skills had doubled in the intervention group (adjusted mean difference 29.6; 95% CI [24.2, 35.1] compared to 1.8; 95% CI [-2.7, 6.3] in the control group). At 12 months skills had further improved in the intervention group (adjusted mean difference 13.3; 95% CI [8.3, 18.3] compared to 3.1; 95% CI [-1.0, 7.3] in the control group). Knowledge scores also significantly improved in the intervention group compared to the control (adjusted mean difference after 12 months 8.5; 95% CI [2.0, 15.0]).
-
8.
Safety and efficacy of intrauterine balloon tamponade vs uterine gauze packing in managing postpartum hemorrhage: A systematic review and meta-analysis
Abul A, Al-Naseem A, Althuwaini A, Al-Muhanna A, Clement NS
AJOG global reports. 2023;3(1):100135
Abstract
BACKGROUND There is debate on whether uterine gauze packing or intrauterine balloon tamponade is safer and more effective as a surgical management option for treating postpartum hemorrhage. OBJECTIVE This study aimed to compare intra- and postoperative outcomes of intrauterine balloon tamponade and uterine gauze packing in patients with postpartum hemorrhage. STUDY DESIGN A range of databases such as Cochrane and PubMed were searched using terms including "post-partum haemorrhage," "uterine balloon tamponade," and "uterine gauze packing." All observational studies comparing intrauterine balloon tamponade with uterine gauze packing were included. Five studies were identified enrolling 821 adult patients diagnosed with postpartum hemorrhage. Primary outcomes included blood loss volume, success rates, and maternal mortality. Secondary outcomes comprised requiring additional interventions, postoperative hemoglobin levels, and requiring blood transfusions. Fixed and random models were used for analysis. RESULTS Intrauterine balloon tamponade seemed to be a superior option to uterine gauze packing. Intrauterine balloon tamponade was better in reducing intraoperative blood loss, with a statistically significant improvement (P<.0001). Cases managed with intrauterine balloon tamponade seemed to have statistically significant shorter operative time (P=.023) and hospital length of stay (P=.020) in one study. CONCLUSION Intrauterine balloon tamponade remains more effective and safer as a first-line surgical management option for postpartum hemorrhage compared with uterine gauze packing.
-
9.
Endometrial ablation and resection versus hysterectomy for heavy menstrual bleeding: an updated systematic review and meta-analysis of effectiveness and complications
Deehan, C., Georganta, I., Strachan, A., Thomson, M., McDonald, M., McNulty, K., Anderson, E., Mostafa, D. A.
Obstetrics & gynecology science. 2023
Abstract
To evaluate the clinical efficacy, safety, and cost-effectiveness of endometrial ablation or resection (E:A/R) compared to hysterectomy for the treatment of heavy menstrual bleeding (HMB). Literature-search was performed for all the randomized control trials (RCTs) comparing (E:A/R) versus hysterectomy for the treatment of HMB. The literature-search was last updated in November 2022. The primary outcomes were objective and subjective reduction in HMB and patient-satisfaction rates in improving the bleeding symptoms at 1-14 years. The data were analyzed using Review Manager software. Twelve RCTs with 2,028 women (hysterectomy: n=977 vs. E:A/R: n=1,051) were included. Hysterectomy was compared with endometrial ablation in 5 studies, endometrial resection in 5 studies, and both ablation and resection in 2 studies. The meta-analysis revealed that the hysterectomy group showed improved patient-reported and objective bleeding-symptoms more than those of the EA/R group with risk ratios (RR) of (MD, 0.75; 95% CI, 0.71 to 0.79) and (MD, 44.00; 95% CI, 36.09 to 51.91), respectively. The patient-satisfaction was higher post-hysterectomy up to a follow-up period of 2 years (RR, 0.90; 95% CI, 0.86 to 0.94) but this effect was absent with long term follow-up. This meta-analysis shows that E:A/R offers alternatives to hysterectomy. Although both procedures are highly effective, safe, and improve the quality of life, hysterectomy is significantly superior at improving the bleeding symptoms and patient satisfaction up to two-years. However, hysterectomy is associated with longer operating times and recovery periods and has a higher rate of postoperative complications. The initial cost of E:A/R is less than that of hysterectomy but further surgical requirements are common, therefore there is no difference in the cost for the long term follow-up.
-
10.
Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial
Whitaker, L. H. R., Middleton, L. J., Daniels, J. P., Williams, A. R. W., Priest, L., Odedra, S., Cheed, V., Stubbs, C. E., Clark, T. J., Lumsden, M. A., et al
EClinicalMedicine. 2023;60:101995
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).