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Sublingual misoprostol versus intravenous oxytocin in the management of postpartum hemorrhage
Beigi A,Tabarestani H,Moini A,Zarrinkoub F
Tehran University Medical Journal , 2009,
Abstract: "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Postpartum hemorrhage is a major cause of maternal mortality and morbidity. It has been identified that active management of third stage of labor is an effective way in preventing postpartum hemorrhage. This randomized controlled trial was conducted to compare sublingual misoprostol versus intravenous oxytocin in the management of postpartum hemorrhage in nulliparous women."n"nMethods: In this randomized controlled trial conducted in Arash hospital from 2006 to 2009, Five hundred forty two nulliparous pregnant women were enrolled. They were randomized to receive either 400 microgram sublingual misoprostol or 20 IU oxytocin intravenously, immediately after the birth of newborn. "n"nResults: Post partum Hemorrhage was significantly lower in women who received sublingual misoprostol (p<0.0001). Patients who received misoprostol had shorter length of third stage of labor (6.45 minute in misoprostol Vs 6.9 minute in oxytocin group, p=0.003). Comparison of hemoglobin levels in two groups before and after delivery showed that there is a significant lesser hemoglobin drop in misoprostol group p=0.046. Side effects were more common in misoprostol group (p<0.0001). However, they were not serious; shivering (35.66%) in misoprostol group and headache (9.63%) in oxytocin group were the most common adverse effects."n"nConclusions: Sublingual misoprostol is more effective than intravenous oxytocin in preventing postpartum hemorrhage and is recommended for prevention of postpartum hemorrhage.
Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make?
Wilfrido León, Jill Durocher, Gustavo Barrera, Ernesto Pinto, Beverly Winikoff
BMC Pregnancy and Childbirth , 2012, DOI: 10.1186/1471-2393-12-65
Abstract: From February to July 2010, an open-label pilot study was conducted in Quito, Ecuador to determine whether a lower dose--600mcg sublingual misoprostol--would result in a lower incidence of high fever (≥40°C). Rates of shivering and fever with 600mcg sublingual regimen were compared to previously documented rates in Ecuador following PPH treatment with 800mcg sublingual misoprostol.The 600mcg dose resulted in a 55% lower rate of high fever compared with the 800mcg regimen (8/50; 16% vs. 58/163; 36%; relative risk 0.45 95% CI 0.23-0.88). Only one woman had severe shivering following the 600mcg dose compared with 19 women in the 800mcg cohort (2% vs. 12%; relative risk 0.17 (0.02-1.25)). No cases of delirium/altered sensorium were reported with the 600mcg dose and women’s assessment of severity/tolerability of shivering and fever was better with the lower dose.600mcg sublingual misoprostol was found to decrease the occurrence of high fever among Ecuadorian women when given to treat PPH. This study however was not powered to examine the efficacy of this treatment regimen and cannot be recommended at this time. Future research is needed to confirm whether other populations, outside of Quito, Ecuador, experience unusually high rates of elevated body temperature following sublingual administration of misoprostol for treatment of PPH. If indeed similar trends are found elsewhere, larger trials to confirm the efficacy of lower dosages may be justified.Clinical trials.gov, Registry No. NCT01080846Misoprostol, a prostaglandin E1 derivative, is a safe and effective alternative for managing postpartum hemorrhage (PPH) due to uterine atony [1,2] however, concerns still remain about its side effects profile [3]. The most common side effects associated with the postpartum administration of misoprostol for PPH are shivering and fever [4]. Rates of shivering and fever have been shown to be higher following oral and sublingual routes of administration compared with rectal and vaginal
Sublingual Misoprostol versus Intramuscular Oxytocin for Prevention of Postpartum Hemorrhage in Uganda: A Double-Blind Randomized Non-Inferiority Trial  [PDF]
Esther C. Atukunda ,Mark J. Siedner,Celestino Obua,Godfrey R. Mugyenyi,Marc Twagirumukiza,Amon G. Agaba
PLOS Medicine , 2014, DOI: 10.1371/journal.pmed.1001752
Abstract: Background Postpartum hemorrhage (PPH) is a leading cause of maternal death in sub-Saharan Africa. Although the World Health Organization recommends use of oxytocin for prevention of PPH, misoprostol use is increasingly common owing to advantages in shelf life and potential for sublingual administration. There is a lack of data about the comparative efficacy of oxytocin and sublingual misoprostol, particularly at the recommended dose of 600 μg, for prevention of PPH during active management of labor. Methods and Findings We performed a double-blind, double-dummy randomized controlled non-inferiority trial between 23 September 2012 and 9 September 2013 at Mbarara Regional Referral Hospital in Uganda. We randomized 1,140 women to receive 600 μg of misoprostol sublingually or 10 IU of oxytocin intramuscularly, along with matching placebos for the treatment they did not receive. Our primary outcome of interest was PPH, defined as measured blood loss ≥500 ml within 24 h of delivery. Secondary outcomes included measured blood loss ≥1,000 ml; mean measured blood loss at 1, 2, and 24 h after delivery; death; requirement for blood transfusion; hemoglobin changes; and use of additional uterotonics. At 24 h postpartum, primary PPH occurred in 163 (28.6%) participants in the misoprostol group and 99 (17.4%) participants in the oxytocin group (relative risk [RR] 1.64, 95% CI 1.32 to 2.05, p<0.001; absolute risk difference 11.2%, 95% CI 6.44 to 16.1). Severe PPH occurred in 20 (3.6%) and 15 (2.7%) participants in the misoprostol and oxytocin groups, respectively (RR 1.33, 95% CI 0.69 to 2.58, p = 0.391; absolute risk difference 0.9%, 95% CI ?1.12 to 2.88). Mean measured blood loss was 341.5 ml (standard deviation [SD] 206.2) and 304.2 ml (SD 190.8, p = 0.002) at 2 h and 484.7 ml (SD 213.3) and 432.8 ml (SD 203.5, p<0.001) at 24 h in the misoprostol and oxytocin groups, respectively. There were no significant differences between the two groups in any other secondary outcomes. Women in the misoprostol group more commonly experienced shivering (RR 1.91, 95% CI 1.65 to 2.21, p<0.001) and fevers (RR 5.20, 95% CI 3.15 to 7.21, p = 0.005). This study was conducted at a regional referral hospital with capacity for emergency surgery and blood transfusion. High-risk women were excluded from participation. Conclusions Misoprostol 600 μg is inferior to oxytocin 10 IU for prevention of primary PPH in active management of labor. These data support use of oxytocin in settings where it is available. While not powered to do so, the study found no significant differences in rate of
Safety and Efficacy of Misoprostol versus Oxytocin for the Prevention of Postpartum Hemorrhage  [PDF]
Minoo Rajaei,Samieh Karimi,Zohreh Shahboodaghi,Hamidreza Mahboobi,Tahereh Khorgoei,Farzam Rajaei
Journal of Pregnancy , 2014, DOI: 10.1155/2014/713879
Abstract: Postpartum hemorrhage (PPH) is the commonest cause of maternal death worldwide. Studies suggest that the use of misoprostol may be beneficial in clinical settings where oxytocin is unavailable. The aim of this study was to compare the safety and efficacy of oxytocin and misoprostol when used in the prevention of PPH. In a double-blind randomized controlled trial, 400 pregnant women who had a vaginal delivery were assigned into two groups: to receive either 20 IU of oxytocin in 1000?mL Ringer’s solution and two placebo tablets or 400?mcg oral misoprostol (as two tablets) and 2?mL normal saline in 1000?mL Ringer’s solution. The quantity of blood loss was higher in the oxytocin group in comparison to the misoprostol group. There was no significant difference in the decrease in hematocrit and hemoglobin between the two groups. Although there was no significant difference in the need for transfusions between the two groups, the patients in the oxytocin group had greater need for additional oxytocin. Results from this study indicate that it may be considered as an alternative for oxytocin in low resource clinical settings. This study is registered with ClinicalTrials.gov NCT01863706. 1. Background Postpartum hemorrhage (PPH) is a life-threatening obstetric emergency that occurs after caesarean section (CS) or normal vaginal delivery (NVD). It may be defined as ≥500?mL hemorrhage after vaginal or ≥1000?mL hemorrhage after CS delivery [1–3]. PPH is one of the most common obstetric maternal complications and is among the three most common etiologies of maternal death worldwide [4]. Its incidence is increasing and it affects 1–5% of all deliveries [5, 6]. Atony is the main cause of PPH and is responsible for about 80% of PPHs [7]. Therefore, uterotonic agents are administered. Oxytocin infusion, single dose of methylergometrine, and then carboprost tromethamine are used in 15-to-20-minute intervals in atony. Misoprostol, which is a prostaglandin E1 analog, is an inexpensive drug and can be absorbed by the following routes of administration: vaginal, rectal, or oral (sublingual or buccal absorption) [8, 9]. Gastrointestinal symptoms (nausea, vomiting, and diarrhea) and fever are the most common adverse effects of misoprostol, which often are mild and self-limited [10–12]. Several studies have shown that misoprostol is more effective than oxytocin and methylergometrine in the treatment of PPH [13, 14]. Although misoprostol can be used as first-line therapy in the treatment of PPH where oxytocin is not available [15], other studies have not confirmed that
Misoprostol in addition to routine treatment of postpartum hemorrhage: A hospital-based randomized-controlled trial in Karachi, Pakistan
Nadeem F Zuberi, Jill Durocher, Rozina Sikander, Neelofur Baber, Jennifer Blum, Gijs Walraven
BMC Pregnancy and Childbirth , 2008, DOI: 10.1186/1471-2393-8-40
Abstract: A randomized controlled trial was conducted in four Karachi hospitals from December 2005 – April 2007 to assess the benefit of a 600 mcg dose of misoprostol given sublingually in addition to standard oxytocics for postpartum hemorrhage treatment. Consenting women had their blood loss measured after normal vaginal delivery and were enrolled in the study after losing more than 500 ml of blood. Women were randomly assigned to receive either 600 mcg sublingual misoprostol or matching placebo in addition to standard PPH treatment with injectable oxytocics. Both women and providers were blinded to the treatment assignment. Blood loss was collected until active bleeding stopped and for a minimum of one hour after PPH diagnosis. Total blood loss, hemoglobin measures, and treatment outcomes were recorded for all participants.Due to a much lower rate of PPH than expected (1.2%), only sixty-one patients were diagnosed and treated for their PPH in this study, and we were therefore unable to measure statistical significance in any of the primary endpoints. The addition of 600 mcg sublingual misoprostol to standard PPH treatments does, however, suggest a trend in reduced postpartum blood loss, a smaller drop in postpartum hemoglobin, and need for fewer additional interventions. Women who bled less overall had a significantly smaller drop in hemoglobin and received fewer additional interventions. There were no hysterectomies or maternal deaths among study participants. The rate of transient shivering and fever was significantly higher among women receiving misoprostolA 600 mcg dose of misoprostol given sublingually shows promise as an adjunct treatment for PPH and its use should continue to be explored for its life-saving potential in the care of women experiencing PPH.Clinical trials.gov, Registry No. NCT00116480Excessive bleeding after childbirth, the leading cause of maternal deaths worldwide, has received international attention among medical and research communities for decad
POSTPARTUM HEMORRHAGE - A REVIEW
I. Marcovici
Jurnalul de Chirurgie , 2005,
Abstract: Postpartum hemorrhage has been defined as either a 10% change in hematocrit between admission and postpartum period or a need of erythrocyte transfusion. The incidence of postpartum hemorrhage is 3.9% for vaginal deliveries and 6.4% for cesarean delivery. Clinically the blood loss is often underestimated by as much as 30% - 50% resulting in a delay in addressing the problem. Postpartum hemorrhage can become rapidly catastrophic. The ACOG ranks postpartum hemorrhage as the third cause of maternal mortality after embolism and hypertensive disease. Predisposing factors for postpartum hemorrhage are: uterine atony (50%), lower genital tract lacerations (20%), uterine abnormalities (20%) etc. Management of the postpartum hemorrhage includes a rapid but thorough physical examination, specifically of the abdominal and pelvic regions, concurrent with laboratory evaluation and volume replacement therapy. Coagulation studies are also necessary. If no genital tract lacerations are found, some maneuvers must be done: uterine exploration followed by uterine massage and blunt curettage, if the products of conception are found in the uterine cavity. If postpartum hemorrhage is due to uterine atony then, uterotonic regimens should be used (methyl-ergonovine, 15-methyl prostaglandin F2 (alpha), prostaglandin E2 or misoprostol). When all other conservative methods of treatment of postpartum hemorrhage failed, before going for invasive procedures as uterine embolization and laparotomy, I strongly suggest the use of Intrauterine Balloon Tamponade. Invasive procedures comprise embolization and laparotomy with conservative techniques (ligation of the uterine blood supply and uterine compression sutures) or hysterectomy or/and Transvaginal Pressure Pelvic Pack. In conclusion, post-partum hemorrhage can become rapidly catastrophic. Once the diagnosis is made, a quick and methodic approach to the problem, following the algorithm bellow, can be very helpful. Also, remember the intrauterine balloon tamponade: very effective, does not require specialized training, it is easy to use and readily available in OR (operating room) and in my opinion it is underutilised.
Comparison of Oxytocin and Misoprostol in Reduction of Postpartum Hemorrhage
Talaat Dabaghi Ghaleh,Fatemeh Lalooha,Faride Movahed,Simindokht Moradi,Omid Mashrabi
Research Journal of Biological Sciences , 2012, DOI: 10.3923/rjbsci.2011.652.655
Abstract: Postpartum hemorrhage ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. Intravenous Oxytocin is using now to reduce of postpartum hemorrhage. With this trial, researchers sought to determine the effectiveness of oral Misoprostol as an Uterotonic drug in comparison with intravenous Oxytocin in patients with a low risk of postpartum hemorrhage undergoing delivery. To compare the effect of 400 μg of oral Misoprostol with 10 IU of intravenous Oxytocin in preventing postpartum hemorrhage. In a randomized controlled trial conducted in Kosar hospital, 300 pregnant women with inclusion criteria received either 400 μg of oral Misoprostol or 10 IU of intravenous Oxytocin after delivery of the anterior shoulder or within 1 min of delivery. Hemoglobin and hematocrit of maternal was checked during admission and 24 h after delivery and compared together. There was no difference between two groups in hematocrit drop in 3.33±3.44 and 2.81±1.26% of the participants in the Oxytocin and Misoprostol group (p = 0.325). The rate of use of additional oxytocin was higher in the Oxytocin group (34.8 vs. 20.5%, p = 0.013). Shivering was higher in misoprostol group (12.3 vs. 2.9%, p = 0.005). Fever occurred only in 2 cases of Misoprostol group (p = 0.236). The routine use of 400 μg of oral misoprostol was no less effective than 10 IU of intravenous oxytocin in reducing blood loss after delivery as assessed by change in postpartum hematocrit and hemoglobin.
A Comparison Between Sublingual Misoprostol and Intravenous Oxytocin for Inducing labor in Women with Term Pregnancy
Leila Habibi,Shirin Niroomanesh,Laleh Ghadirian
Journal of Family and Reproductive Health , 2012,
Abstract: Objective: In this study efficacy of sub lingual Misoprostol was examined in comparison to Oxytocin (I.V.) for inducing of labor in term pregnancy.Materials and methods: Seventy patients were allocated by blocked randomization to Groups A (n=35, sub lingual Misoprostol 25 μg four hourly to maximum of 5 doses) and B (n=35, continuous Oxytocin infusion).Results: Delivery active phase and total labor phase were shorter with sublingual Misoprostol in comparison to intravenous Oxytocin (p< 0.001) and the rate of cesarean section was lower in Misoprostol group (p<0.04) but delivery latent phase, meconium staining, uterine hypertonisity and apgar score (1&5 minute) were similar in two groups.Conclusion: sublingual Misoprostol is better than intravenous Oxytocin for induction of labor at term.
Development of Misoprostol Suppositories for Postpartum Hemorrhage  [PDF]
Isabelle O. Constantin, Georges L. Zelger, Anne-Lise Paroz, Pascal Furrer, Serge Rudaz, Corinne Planchamp Messeiller
Pharmacology & Pharmacy (PP) , 2013, DOI: 10.4236/pp.2013.41010
Abstract: Misoprostol is a prostaglandin E1 analogue used to prevent and treat gastric ulcers. It has been commonly used in gynecology and obstetrics, especially for the management of postpartum hemorrhage (PPH). For this purpose, 1000 μg intrarectal (insertion of five 200 μg tablets) has been recommended as the third line after injectable oxytocin and methylergometrine. We proposed to manufacture a 1000 μg misoprostol suppository by determining formulation, release and stability. The administration facility was also evaluated. Several formulations of misoprostol suppositories were set up and evaluated. Misoprostol tablets and lipophilic bases (Hard fatAdeps solidus Ph. Eur., Witepsol? H15 and Suppocire? AM and AS2X) were used to obtain suppositories. Surfactants were also tested (polysorbates Tween? 20, Tween? 80 and sodium lauryl sulfate (SLS)). The formula was monitored by the misoprostol release curve with an in vitro test and dosed by a HPLC method. Stability was determined by evaluating the percentage of misoprostol content remaining over the time in suppositories stored at 4℃ and 25℃. Facility of use versus tablets was evaluated by obstetricians of a Swiss regional hospital using a questionnaire. Misoprostol release was facilitated by adding surfactant to the lipophilic base. After 30 minutes, 59% ± 1.4% and 57% ± 8.2% of misoprostol was released with Adeps solidus + 1% SLS and Adeps solidus + 5% Tween 20 respectively. SLS was discarded to the final formula because of its irritating effect. After 7 months, suppositories still contained 94% ± 3.7% misoprostol with storage at 4℃. The administration was considered easier and faster compared with intra rectal use of tablets. The formula, consisting of 5 crushed misoprostol tablets dispersed in a suppository base made of Adeps solidus + 5% Tween? 20, is stable for at least 7 months at 4?C and facilitates the rectal administration of misoprostol in the treatment of PPH.


Baixa dose de misoprostol sublingual (12,5 μg) para indu??o do parto
Gattás, Daniele Sofia de Moraes Barros;Souza, Alex Sandro Rolland;Souza, Caroline Gomes Fernandes de;Florentino, André Vinícius de Assis;Nóbrega, Bianca Virgolino;Fook, Valéria Pascoal de Oliveira Lia;Amorim, Melania Maria Ramos;
Revista Brasileira de Ginecologia e Obstetrícia , 2012, DOI: 10.1590/S0100-72032012000400005
Abstract: purpose: to describe the maternal and perinatal outcomes after the use of 12.5 μg of sublingual misoprostol for labor induction in women with term pregnancy and a live fetus. methods: we conducted a multicenter, open and non-randomized clinical trial during the period from july to december 2009. we included 30 pregnant women with an indication for labor induction at term, carrying a live fetus, with a bishop score of six or less, cephalic presentation, estimated fetal weight of less than 4,000 g and an amniotic fluid index greater than five. we excluded women with a previous uterine scar, non-reassuring fetal status, congenital anomalies, multiple pregnancy, intrauterine growth restriction, genital bleeding, and contraindications of vaginal delivery. a tablet of 12.5 μg sublingual misoprostol was administered every six hours, until the beginning of labor, with the maximum of eight doses. results: labor was successfully induced in 90% of pregnant women. the mean interval between the first dose and the onset of uterine contractions and delivery was 14.3±11.7 hours and 25.4±13 hours, respectively. the frequency of vaginal delivery was 60%. uterine tachysystole occurred in two pregnant women, being reversed in both cases without the need for cesarean section. meconium-stained amniotic fluid was observed in four patients, and an apgar score of less than 7 at five minutes in only one newborn. conclusion: maternal and perinatal outcomes were favorable after induction of labor with sublingual misoprostol at a dose of 12.5 μg every six hours. however, controlled trials are needed to compare this regimen with other doses and routes of administration.
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