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1.
Reducing patient's perception of postoperative vaginal bleeding after laparoscopic hysterectomy via independent closure of the vaginal cuff angles (RCT)
Radtke, S., Arms, R., Son, M. A., Sanchez, S., Singh, V., Bencomo, M., McCall, E., Rodriguez, S., Olivas-Cardiel, K.
European journal of obstetrics, gynecology, and reproductive biology. 2024;294:111-116
Abstract
STUDY OBJECTIVE Determine if independently suturing the vaginal cuff angles in addition to running barbed suture has an effect on patients' perception of postoperative bleeding after laparoscopic hysterectomy. DESIGN Randomized controlled trial. SETTING University-based medical center. PATIENTS Females ages 18-60 undergoing laparoscopic hysterectomy. INTERVENTIONS Patients were randomly assigned to either cuff closure via single layer of barbed suture (control) vs adding figure-of-eight stitches at each angle (intervention). A survey was given between 10 and 25 days after surgery inquiring about bleeding and dyspareunia. A second survey was given between postoperative days 90-114. Chart review was performed to record emergency room visits, complications, infections, and reoperations during the first 90 postoperative days. RESULTS n = 117 patients were analyzed. 62 (control) and 55 (intervention). Groups were similar in terms of age (42.92 v 44.29p =.35), BMI (33.79 v 34.06p =.85), diabetes (5.26 % (3/55) v 15.09 % (8/53) p =.08) p =.97). Bleeding was decreased in intervention arm (24.19 % (15/62) v 9.09 % (5/55) p =.03). Median (IQR) pelvic pain score was similar (2.0 (0-5.0) v 2.0 (0-4.0) p =.26). Median total operative time (IQR) (129 min (102, 166) v 139 min (120, 163) p =.39) and median EBL (IQR) (50 mL (30-75) vs 50 mL (20-75) p =.43) were similar. Cuff closure in seconds (IQR) was higher in intervention group (373 sec (323, 518) v 571 sec (520, 715) p <.01). 8/60 control patients visited the ED (13.33 %) v 7/54 (12.96 %) p =.95. Readmissions (1.67 % (1/60) v 1.85 % (1/55) p = 1), re-operations (0 % (0/60) v 1.85 % (1/55) p =.47) and postoperative infections (5.0 % (3/60) v 1.85 % (1/54) p =.62) were similar. Secondary survey showed no significant difference in bleeding (15.38 % (4/26) v 4.35 % (1/23) p =.35) and SF-36 results were similar. CONCLUSION Independently suturing the vaginal cuff angles reduces patients' perception of vaginal bleeding in the early postoperative period. Incidence of complications, reoperations, and long-term quality of life are similar.
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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.
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Minimizing blood loss in laparoscopic myomectomy with temporary occlusion of the hypogastric artery
Balulescu, L., Nistor, S., Lungeanu, D., Brasoveanu, S., Pirtea, M., Secosan, C., Grigoras, D., Caprariu, R., Pasquini, A., Pirtea, L.
Frontiers in medicine. 2023;10:1216455
Abstract
INTRODUCTION Uterine leiomyomas are common benign pelvic tumors. Currently, laparoscopic myomectomy (LM) is the preferred treatment option for women in the fertile age group with symptomatic myomas. The authors hypothesize that combining LM with a bilateral temporary occlusion of the hypogastric artery (TOHA) using vascular clips minimizes uterine blood flow during surgery and can significantly reduce surgery-associated blood loss. MATERIALS AND METHODS This single-center, prospective randomized study was conducted at the Department of Obstetrics and Gynecology, Municipal Emergency Clinical Hospital Timisoara, Romania. Patients aged between 18 and 49 who preferred laparoscopic myomectomy and wished to preserve fertility were included, provided they had intramural uterine leiomyomas larger than 4 cm in diameter that deformed the uterine cavity. The study analyzed data from 60 laparoscopic myomectomies performed by a single surgeon between January 2018 and December 2020. Patients were randomly assigned to either: "LM + TOHA" group (29 patients), and "LM" group (31 patients). The study's main objective was to evaluate the impact of TOHA on perioperative blood loss, expressed as mean differences in Hb (delta Hb). RESULTS Delta Hb was statistically lower in the "LM + TOHA" group compared to "LM" group, with mean ± standard (min-max): 1.68 ± 0.67 (0.39-3.99) vs. 2.63 ± 1.06 (0.83-4.92) g/dL, respectively (p < 0.001). There was a statistically significant higher need for postoperative iron perfusion in the "LM" group, specifically 0 vs. 12 patients (p < 0.001), and lower postoperative anemia in "LM + TOHA" group (p < 0.001). Necessary artery clipping time was 10.62 ± 2.47 (7-15) minutes, with no significant impact on overall operative time: 110.2 ± 13.65 vs. 106.3 ± 16.48 (p = 0.21). There was no difference in the length of hospitalization or 12-month post-intervention fertility. DISCUSSION Performing bilateral TOHA prior to laparoscopic myomectomy has proven to be a valuable technique in reducing surgery-associated blood loss, while minimizing complications during surgery, with no significant increase in the overall operative time. CLINICAL TRIAL REGISTRATION ISRCTN registry, (www.isrctn.com), identifier ISRCTN66897343.
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4.
The Efficiency of a Uterine Isthmus Tourniquet in Minimizing Blood Loss during a Myomectomy-A Prospective Study
Balulescu, L., Brasoveanu, S., Pirtea, M., Balint, O., Ilian, A., Grigoras, D., Olaru, F., Margan, M. M., Alexandru, A., Pirtea, L.
Medicina (Kaunas, Lithuania). 2023;59(11)
Abstract
Background and Objectives: The objective of this study was to assess the effectiveness of using a peri-cervical tourniquet in reducing blood loss during a laparoscopic myomectomy. Materials and Methods: This prospective study evaluated the impact of performing a concomitant tourniquet placement during a laparoscopic myomectomy (LM). A total of 60 patients were randomly allocated to one of two groups: 30 patients who underwent an LM with a tourniquet placement (the TLM group) and 30 patients who benefited from a standard LM (the SLM group). This study's main objective was to evaluate the impact of tourniquet use on perioperative blood loss, which is quantified as the difference in the pre- and postoperative hemoglobin levels (Delta Hb) and the postoperative blood transfusion rate. Results: The mean Delta Hb was statistically lower in the TLM group compared to the SLM group: 1.38 g/dL vs. 2.41 g/dL (p < 0.001). The rate of postoperative iron perfusion in the TLM group was significantly lower compared to the SLM group (4 vs. 13 patients; p = 0.02). All four patients that required a blood transfusion were from the SLM group. On average, the peri-cervical tourniquet fastening time was 10.62 min (between 7 and 15 min), with no significant impact on the overall operative time: 98.50 min for the TLM group compared to 94.66 min for the SLM group. Conclusions: Fastening a tourniquet during a laparoscopic myomectomy is a valuable technique to effectively control intraoperative bleeding and enhance surgical outcomes.
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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.
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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.
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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.
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8.
Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial
Gümüsburun, N., Yapca, O. E., Ozdes, S., Al, R. A.
Archives of gynecology and obstetrics. 2023
Abstract
PURPOSE This study aimed to compare the effect of triple uterine tourniquet and single tourniquet on intraoperative blood loss during open myomectomy. METHODS Women were randomized to undergo open myomectomy with a triple (n = 30) or single uterine tourniquet (n = 30). All symptomatic women aged 18-48 who had three or more myomas or at least one myoma greater than 8 cm if there were less than three myomas were eligible for the study. The primary outcome variable was the volume of intraoperative blood loss. The sample size was set to detect a 240 ml difference in blood loss with 80% power at α = 0.05, with an effect size of 0.8. The rate of transfusions, change in hemoglobin, volume of drains, operation time, tourniquet time, and perioperative complications were secondary outcomes. RESULTS We found no significant difference in intraoperative blood loss between triple and single uterine tourniquets (527 [102-2931]) ml vs. 508 [172-2764] ml, p = 0.238). Between the single and triple tourniquet groups, the median weight of myoma (379 [136-3850] vs. 330 [140-1636] g, p = 0.451) and median number (1 [1-18] vs. 2 (1-13), p = 0.214), total operation time (84 ± 31 min vs. 79 ± 27 min, p = 0.503), ischemia time (35 ± 21 min vs. 30 ± 14 min., p = 0.238), drain volume at 48th hour (196 ± 89)ml vs. 243 ± 148 ml, p = 0.144) and decrease in hemoglobin (2.3 ± 1.8 g/dl vs. 2.8 ± 1.4 g/dl, p = 0.437) were similar. Eight (27%) patients in the triple tourniquet group and 12 (40%) patients in the single tourniquet group were transfused (p = 0.273). One patient underwent hysterectomy 6-8 h after myomectomy in a single tourniquet group. CONCLUSION There was no clinically significant difference in intraoperative blood loss between triple and single uterine tourniquets during open myomectomy. CLINICAL TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION ClinicalTrials.gov ID: NCT02392585, 03/13/2015.
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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.
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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
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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]).