The Effect of Combined Oxytocin-Misoprostol Versus Oxytocin and Misoprostol Alone in Reducing Blood Loss at Cesarean Delivery: A Prospective Randomized Double-Blind Study.
Ontology highlight
ABSTRACT:
SUBMITTER: Pakniat H
PROVIDER: S-EPMC4666219 | biostudies-literature | 2015 Dec
REPOSITORIES: biostudies-literature
Publications
The Effect of Combined Oxytocin-Misoprostol Versus Oxytocin and Misoprostol Alone in Reducing Blood Loss at Cesarean Delivery: A Prospective Randomized Double-Blind Study.
Pakniat Hamideh H Khezri Marzieh Beigom MB
Journal of obstetrics and gynaecology of India 20150124 6
<h4>Purpose</h4>To compare the effect of combined oxytocin-misoprostol versus oxytocin and misoprostol alone in reducing blood loss at cesarean delivery.<h4>Methods</h4>One hundred fifty patients of 18-40 years with singleton term pregnancies scheduled for cesarean section under spinal anesthesia were recruited in a prospective double-blind randomized clinical trial to one of the three following groups to receive 20 IU infusion of oxytocin (group O), 400-µg sublingual misoprostol tablets (group ...[more]
Similar Datasets
Project description:Purpose:To evaluate the effects of intravenous tranexamic acid (TA) and sublingual misoprostol on reducing bleeding after cesarean section. Materials:One hundred and fifty-eight participants with term pregnancies scheduled for cesarean section were randomly divided into two groups. In M group, two sublingual misoprostol pills (400 mg) were administrated, immediately after the delivery. In TA group, ten minutes before skin incision, TA ampoule (1 g) was injected. In both groups, immediately after the delivery, 20 units of oxytocin in 1 L ringer lactate with speed of 1000 CC/h was injected. At the end of the operation, the amount of bleeding was measured based on the number of small and large gauzes, the blood in the suction container and the difference of patient's hemoglobin before and 24 h after surgery. Results:Hemoglobin level reduction in the TA group was higher than the M group (-?2.45?±?0.84 vs -?2.14?±?1.38 g/dL) (P?<?0.001). Furthermore, number of used gauze and blood suction in the TA group was significantly higher compared to sublingual misoprostol (4.67?±?1.34 vs 3.25?±?1.31 and 260.25?±?79.06 vs 193.94?±?104.79 cc, respectively) (P?<?0.001). Mean blood pressure during the entire duration of surgery in the TA group decreased significantly as compared to the M group (P?<?0.001). Conclusion:Total bleeding was significantly lower in sublingual misoprostol as compared to the tranexamic acid group. Furthermore, in misoprostol group hemodynamic variables were stabilized greater than tranexamic acid group. Registration Number:IRCT201708308611N6.
| S-EPMC6531555 | biostudies-literature
Project description:BACKGROUND:The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. METHODS:MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 ?g 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ?30 years), body-mass index (<35 kg/m2vs ?35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ?70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ?2 vs ?3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. FINDINGS:Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. INTERPRETATION:Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. FUNDING:UK National Institute for Health Research Health Technology Assessment Programme.
| S-EPMC7493715 | biostudies-literature
Project description:ObjectiveTo evaluate whether cervical ripening with oral misoprostol increases cesarean delivery risk and prolongs time to vaginal delivery compared with vaginal misoprostol in a predominantly overweight population.MethodsThis single center, retrospective cohort study was performed at a tertiary care academic medical center and compared labor induction outcomes with vaginal misoprostol to outcomes with oral misoprostol after a complete institutional shift to oral misoprostol. Labor induction using 25 micrograms vaginal misoprostol in 2013-2014 was compared with 50 micrograms oral misoprostol in 2014-2015. The primary outcome was cesarean delivery. Secondary outcomes included time to vaginal delivery, uterine tachysystole, maternal hemorrhage, and composite adverse neonatal outcomes. Demographics and outcomes were analyzed using standard statistical tests. Multivariable regression models accounting for potential confounders were created for the primary and secondary outcomes with adjusted odds ratios (aOR) as the measures of effect.ResultsThere were 138 women in the oral and 138 women in the vaginal misoprostol groups. In the overall cohort, the median (interquartile range) body mass index was 31.7 (28.2-36.8) and most women (72%) were of either black or Hispanic race or ethnicity. The frequency of cesarean delivery was higher in the oral than the vaginal misoprostol group (32% vs 21%; P=.04). The adjusted odds of cesarean was higher with oral misoprostol (aOR 2.01; 95% CI 1.07-3.76). Among nulliparous women, the frequency of cesarean delivery was 41% in the oral and 28% in the vaginal misoprostol groups (aOR 2.79; 95% CI 1.26-6.19). Women had a longer time to vaginal delivery in the oral compared with vaginal misoprostol group (41 vs 31 hours respectively, P=.01). Tachysystole occurred more frequently with vaginal misoprostol (20% vs 11%; P=.04).ConclusionCompared with vaginal misoprostol, oral misoprostol may be associated with increased risk of cesarean delivery and longer time to vaginal delivery.
| S-EPMC9234943 | biostudies-literature
Project description:BackgroundPostpartum 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 findingsWe 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.ConclusionsMisoprostol 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 severe PPH, need for blood transfusion, postpartum hemoglobin, change in hemoglobin, or use of additional uterotonics between study groups. Further research should focus on clarifying whether and in which sub-populations use of oxytocin would be preferred over sublingual misoprostol.Trial registrationClinicalTrials.gov NCT01866241 Please see later in the article for the Editors' Summary.
| S-EPMC4219663 | biostudies-literature
Project description:Background and objectivesThe similarities between the melatonin and oxytocin signaling could lead to increased contractility of myometrium. We designed this randomized double-blind, placebo-controlled trial to evaluate the efficacy of melatonin in reduction of blood loss during and after the lower segment cesarean section.MethodsOne hundred and twenty patients who had been scheduled for cesarean section under spinal anesthesia were enrolled in the study. We randomly allocated them to one of the three following groups to receive either melatonin 3 mg (M3), melatonin 6 mg (M6), or placebo (P) sublingually 20 min before the surgery. The hemoglobin levels before and 12 h after surgery, the mean weight of the materials used in the operation time, the need for additional oxytocic therapy, and the incidence of adverse effects were probed and recorded.ResultsThere was a significant difference between the group M6 and both M3 and P in the mean weight of the materials (p = .024 and .041, respectively) and between M6 and P groups in terms of mean decrease in hemoglobin during 12 h after cesarean section (p = .029).ConclusionUsing 6 mg melatonin, sublingually, as a premedication in patients undergoing cesarean section with spinal anesthesia could statistically reduce the amount of blood loss after the lower segment cesarean section, although it may not be clinically meaningful.Registration number: ACTRN12612000117819 and ClinicalTrials.gov Identifier: NCT01572805.
| S-EPMC6765044 | biostudies-literature
Project description:BackgroundEvery year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared.MethodsThis pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women's experience are also planned.DiscussionAvoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman's care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin.Trial registrationClinical Trials.gov, NCT03749902 , registered on 21st Nov 2018.
| S-EPMC8320158 | biostudies-literature
Project description:BackgroundWorldwide, millions of women seek treatment for early pregnancy loss (EPL) annually. Medical management with misoprostol is widely used, but only effective 60% of the time. Pre-treatment with mifepristone prior to misoprostol might improve the success rate of medical management.MethodsThis was a multi-centre, double-blind, placebo-controlled randomised trial in 17 Dutch hospitals. Women with a non-viable pregnancy between 6 and 14 weeks of gestation were eligible for inclusion after at least one week of expectant management. Participants were randomised (1:1) between oral mifepristone 600 mg or an oral placebo tablet. Participants took 400 μg misoprostol orally, repeated after four hours on day two and, if necessary, day three. Primary outcome was expulsion of gestational sac and endometrial thickness <15 mm after 6-8 weeks. Analyses were done according to intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT03212352.FindingsBetween June 28th 2018 and January 8th 2020, 175 women were randomised to mifepristone and 176 to placebo, including 344 in the intention-to-treat analysis. In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group (p<0•0001, RR 1•35, 95% CI 1•16-1•56). Incidence of serious adverse events was significantly lower in the mifepristone group with 24 (14%) patients affected versus 55 (32%) in the placebo group (p = 0•0005) (Table 3).InterpretationPre-treatment with mifepristone prior to misoprostol was more effective than misoprostol alone in managing EPL.FundingHealthcare Insurers Innovation Foundation, Radboud University Medical Centre, Canisius Wilhelmina Hospital.
| S-EPMC7910666 | biostudies-literature
Project description:Postpartum hemorrhage is the leading cause of maternal morbidity and mortality worldwide, with uterine atony estimated to account for 70% to 80% of cases, thereby remaining the single most common cause. Pharmacotherapy remains the first-line preventative therapy for postpartum hemorrhage. These therapies may be single (oxytocin, carbetocin, methylergonovine, ergometrine, misoprostol, prostaglandin analogs, or tranexamic acid) or combination therapies, acting in an additive, infra-additive, or synergistic fashion to prevent postpartum hemorrhage. Evidence is strong for the use of oxytocin, the first-line uterotonic agent in the United States for prevention of postpartum hemorrhage. Although carbetocin, a long-acting analog of oxytocin, is not yet available for use in the United States, it is likely the most effective single pharmacologic therapy for prevention of postpartum hemorrhage and need for additional uterotonics. Use of second-line uterotonics such as methylergonovine, misoprostol, and carboprost in combination with oxytocin has an additive or synergistic effect and a greater risk reduction for postpartum hemorrhage prevention compared with oxytocin alone. Therefore, combined therapy rather than oxytocin alone should be advised for preventing postpartum hemorrhage. Tranexamic acid has been found to be both effective and safe for decreasing maternal mortality in women with postpartum hemorrhage, and prophylactic use of tranexamic acid may decrease the need for packed red blood cell transfusions and/or uterotonics. The WOMAN-2 Trial, designed to assess if tranexamic acid prevents postpartum hemorrhage in women with moderate to severe anemia undergoing vaginal delivery, is currently recruiting participants. The additive, infra-additive, or synergistic action of oxytocin in combination with other second-line therapies deserves further study.
| S-EPMC9941051 | biostudies-literature
Project description:BackgroundIn case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately 50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL.Methods and findingsA cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46-219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups.ConclusionThe sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management.
| S-EPMC8827447 | biostudies-literature
Project description:OBJECTIVE:To examine the association of a resident-driven quality initiative with cesarean delivery surgical site infections. METHODS:This was a quasi-experimental, preintervention and postintervention study of women undergoing cesarean delivery at 23 weeks of gestation or greater between January 2015 and June 2018 at a single tertiary care center. We implemented a resident-driven, evidence-based surgical bundle, excluding women who underwent emergency cesarean or had chorioamnionitis. The bundle included routine prophylactic antibiotics (both cefazolin and azithromycin), chlorhexidine alcohol skin preparation, use of clippers instead of a razor, vaginal cleansing with povidone iodine, placental removal by umbilical cord traction, subcutaneous tissue closure if wound thickness greater than 2 cm, suture skin closure, dressing removal between 24 and 48 hours, and use of postoperative chlorhexidine soap. Our primary outcome was surgical site infections (superficial incisional, deep incisional, and organ or space surgical site infections) occurring up to 6 weeks postpartum. Outcomes were compared between the preimplementation period (January 2015-August 2016) and postimplementation period (December 2016-June 2018). Coarsened Exact Matching with k-to-k solution was performed using age, race-ethnicity, body mass index, rupture of membranes, and labor. RESULTS:In total, 1,624 underwent cesarean delivery in the preimplementation and 1,523 postimplementation periods, respectively; 1,100 women in the postimplementation period were matched to 1,100 women in the preimplementation period. The rate of surgical site infections in the unmatched cohort was significantly lower in the postimplementation period compared to those in the preimplementation period (2.2% [33/1,523] vs 4.5% [73/1,624]; odds ratio [OR] 0.47 [95% CI 0.31-0.71]; P<.001). This decrease in the rate of surgical site infections remained statistically significant after matching (1.9% [21/1,100] vs 4.1% [45/1,100]; OR 0.46 [0.27-0.77]; P<.001). CONCLUSION:After implementation of a resident-driven quality initiative using a surgical bundle, we observed a significant decrease in cesarean surgical site infections.
| S-EPMC6353635 | biostudies-literature