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The Cochrane Database of Systematic... Feb 2018Postpartum haemorrhage (PPH) - heaving bleeding within the first 24 hours after giving birth - is one of the main causes of death of women after childbirth.... (Review)
Review
BACKGROUND
Postpartum haemorrhage (PPH) - heaving bleeding within the first 24 hours after giving birth - is one of the main causes of death of women after childbirth. Antifibrinolytics, primarily tranexamic acid (TXA), have been shown to reduce bleeding in surgery and safely reduces mortality in trauma patients with bleeding without increasing the risk of adverse events.An earlier Cochrane review on treatments for primary PPH covered all the various available treatments - that review has now been split by types of treatment. This new review concentrates only on the use of antifibrinolytic drugs for treating primary PPH.
OBJECTIVES
To determine the effectiveness and safety of antifibrinolytic drugs for treating primary PPH.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (28 May 2017) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs), including cluster-randomised trials of antifibrinolytic drugs (aprotinin, TXA, epsilon-aminocaproic acid (EACA) and aminomethylbenzoic acid, administered by whatever route) for primary PPH in women.Participants in the trials were women after birth following a pregnancy of at least 24 weeks' gestation with a diagnosis of PPH, regardless of mode of birth (vaginal or caesarean section) or other aspects of third stage management.We have not included quasi-randomised trials, or cross-over studies. Studies reported as abstracts have not been included if there was insufficient information to allow assessment of risk of bias.In this review we only identified studies looking at TXA.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from each study using an agreed form. We entered data into Review Manager software and checked for accuracy.For key review outcomes, we rated the quality of the evidence as 'high', 'moderate', 'low' or 'very low' according to the GRADE approach.
MAIN RESULTS
Three trials (20,412 women) met our inclusion criteria. Two trials (20,212 women) compared intravenous (IV) TXA with placebo or standard care and were conducted in acute hospital settings (labour ward, emergency department) (in high-, middle- and low-income countries).One other trial (involving 200 women) was conducted in Iran and compared IV TXA with rectal misoprostol, but did not report on any of this review's primary or GRADE outcomes. There were no trials that assessed EACA, aprotinin or aminomethylbenzoic acid.Standard care plus IV TXA for the treatment of primary PPH compared with placebo or standard care aloneTwo trials (20,212 women) assessed the effect of TXA for the treatment of primary PPH compared with placebo or standard care alone. The larger of these (The WOMAN trial) contributed over 99% of the data and was assessed as being at low risk of bias. The quality of the evidence varied for different outcomes, Overall, evidence was mainly graded as moderate to high quality.The data show that IV TXA reduces the risk of maternal death due to bleeding (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.65 to 1.00; two trials, 20,172 women; quality of evidence: moderate). The quality of evidence was rated as moderate due to imprecision of effect estimate. The effect was more evident in women given treatment between one and three hours after giving birth with no apparent reduction when given after three hours (< one hour = RR 0.80, 95% CI 0.55 to 1.16; one to three hours = RR 0.60, 95% CI 0.41 to 0.88; > three hours = RR 1.07, 95% 0.76 to 1.51; test for subgroup differences: Chi² = 4.90, df = 2 (P = 0.09), I² = 59.2%). There was no heterogeneity in the effect by mode of birth (test for subgroup differences: Chi² = 0.01, df = 1 (P = 0.91), I² = 0%). There were fewer deaths from all causes in women receiving TXA, although the 95% CI for the effect estimate crosses the line of no effect (RR 0.88, 95% CI 0.74 to 1.05; two trials, 20,172 women, quality of evidence: moderate). Results from one trial with 151 women suggest that blood loss of ≥ 500 mL after randomisation may be reduced (RR 0.50, 95% CI 0.27 to 0.93; one trial, 151 women; quality of evidence: low). TXA did not reduce the risk of serious maternal morbidity (RR 0.99, 95% CI 0.83 to 1.19; one trial, 20,015 women; quality of evidence: high), hysterectomy to control bleeding (RR 0.95, 95% CI 0.81 to 1.12; one trial, 20,017 women; quality of evidence: high) receipt of blood transfusion (any) (RR 1.00, 95% CI 0.97 to 1.03; two trials, 20,167 women; quality of evidence: moderate) or maternal vascular occlusive events (any), although results were imprecise for this latter outcome (RR 0.88, 95% CI 0.54 to 1.43; one trial, 20,018 women; quality of evidence: moderate). There was an increase in the use of brace sutures in the TXA group (RR 1.19, 95% CI 1.01, 1.41) and a reduction in the need for laparotomy for bleeding (RR 0.64, 95% CI 0.49, 0.85).
AUTHORS' CONCLUSIONS
TXA when administered intravenously reduces mortality due to bleeding in women with primary PPH, irrespective of mode of birth, and without increasing the risk of thromboembolic events. Taken together with the reliable evidence of the effect of TXA in trauma patients, the evidence suggests that TXA is effective if given as early as possible.Facilities for IV administration may not be available in non-hospital settings therefore, alternative routes to IV administration need to be investigated.
Topics: Antifibrinolytic Agents; Cause of Death; Female; Humans; Maternal Mortality; Misoprostol; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Tranexamic Acid
PubMed: 29462500
DOI: 10.1002/14651858.CD012964 -
Contraception Apr 2023We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40...
OBJECTIVES
We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40 participants seeking medication abortion up to 63 days' gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 days later by misoprostol 800 mcg buccally at home. They took a second dose of misoprostol if they had no bleeding within 24 hours of the first. Participants returned 7 to 10 days later for assessment of abortion outcome and side effects RESULTS: Thirty-seven participants (93%) returned for follow-up and 2 (5%) went to another facility from which research staff obtained outcome data. Three-fourths (29/39, 74%, 95% CI: 60%-89%) had a complete abortion; 4 (10%, 95% CI: 0.3%-20%) had an incomplete abortion and opted for aspiration, and 6 (15%, 95% CI: 4%-27%) had an ongoing pregnancy. All subjects with follow-up reported taking the first dose of misoprostol. Ten (27%) took the second dose as well; only three did so due to no bleeding. Nineteen participants (51%) reported side effects after letrozole prior to misoprostol and two people (5%) rated these effects as severe. Side effects following misoprostol occurred in 33 participants (89%) and were as expected based on previous literature. No serious adverse events were reported CONCLUSION: A single dose of letrozole 30 mg followed by misoprostol had lower than desirable efficacy and does not warrant further study.
IMPLICATIONS
A single dose of letrozole does not appear to be an effective adjunct to misoprostol for medication abortion.
Topics: Pregnancy; Female; Humans; Misoprostol; Letrozole; Pilot Projects; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Mifepristone; Administration, Intravaginal
PubMed: 36529240
DOI: 10.1016/j.contraception.2022.109924 -
Journal of Cancer Research and... 2022To investigate the ease of tandem application and external os identification by giving sublingual misoprostol before initiation of intracavitary brachytherapy in cancer... (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To investigate the ease of tandem application and external os identification by giving sublingual misoprostol before initiation of intracavitary brachytherapy in cancer cervix patients.
MATERIALS AND METHODS
36 patients with cervical cancer stage IIIB which were supposed to undergo intracavitary brachytherapy(ICBT) were randomly divided into 2 subgroups, group A patients receiving misoprostol and group B not receiving misoprostol.Misoprostol 400 mcg was given sublingually 3 hrs prior to the procedure. The efficacy of the drug was measured as per the ease of identification of os and easier tandem application and amount of bleeding during procedure.
RESULTS
Application of tandem and identification of external os was easier and amount of bleeding was also less in patients that were administered sublingual misoprostol.
CONCLUSION
Sublingual Misoprostol given before ICBT helps in cervical ripening and thus leads to easier os recognition and central tandem application and reduce overall anaesthesia time.
Topics: Pregnancy; Female; Humans; Misoprostol; Brachytherapy; Uterine Cervical Neoplasms; Cervix Uteri; Carcinoma
PubMed: 36412412
DOI: 10.4103/jcrt.JCRT_116_20 -
Acta Obstetricia Et Gynecologica... Mar 2024Obesity is an increasing public health concern worldwide and can lead to more complications in pregnancy and childbirth. Women with obesity more often require induction...
INTRODUCTION
Obesity is an increasing public health concern worldwide and can lead to more complications in pregnancy and childbirth. Women with obesity more often require induction of labor for various indications. The aim of this study is to assess which method of induction of labor is safest and most effective in women with obesity.
MATERIAL AND METHODS
This is a secondary analysis of two randomized controlled trials about induction of labor. Women with a term singleton pregnancy in cephalic presentation, an unfavorable cervix, intact membranes and without a previous cesarean section were randomly allocated to cervical priming with a Foley catheter or vaginal prostaglandin-E2-gel (PROBAAT-I) or a Foley catheter or oral misoprostol (PROBAAT-II). The inclusion and exclusion criteria for the studies were identical. Induction methods were compared in women with obesity (body mass index ≥30.0). Main outcomes were cesarean section and postpartum hemorrhage (blood loss >1000 mL).
RESULTS
A total of 2664 women, were included in the trials, 517 of whom were obese: 254 women with obesity received a Foley catheter, 176 oral misoprostol and 87 prostaglandin E2 (PGE2). A cesarean section was performed in 29.1% of women allocated to Foley vs 22.2% in the misoprostol and 23.0% in the PGE2 groups. Comparisons between groups revealed no statistically significant differences: the relative risk [RR] was 1.31 (95% confidence interval [CI] 0.94-1.84) in the Foley vs misoprostol group and 1.27 (95% CI 0.83-1.95) in the Foley vs PGE2 group. The rates of postpartum hemorrhage were comparable (10.6%, 11.4% and 6.9%, respectively; P = 0.512). In women with obesity, more often a switch to another method occurred in the Foley group, (20.1% vs 6.3% in misoprostol vs 1.1% in the PGE2 group; P < 0.001). The risk of a failed Foley placement was higher in women with obesity than in women without obesity (8.3% vs 3.2%; adjusted odds ratio 3.12, 95% CI 1.65-5.90).
CONCLUSIONS
In women with obesity we found a nonsignificant trend towards an increased rate of cesarean sections in the group induced with a Foley catheter compared to oral misoprostol; however, the study lacked power for this subgroup analysis. The finding of a higher risk of failed placement of a Foley catheter in women with obesity can be used in shared decision making.
Topics: Pregnancy; Female; Humans; Misoprostol; Dinoprostone; Oxytocics; Cesarean Section; Postpartum Hemorrhage; Labor, Induced; Randomized Controlled Trials as Topic; Cervical Ripening
PubMed: 38183287
DOI: 10.1111/aogs.14737 -
Obstetrics and Gynecology Apr 2021To estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists.
OBJECTIVE
To estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists.
METHODS
We conducted a prospective cohort study at eight clinical sites and pharmacies in California and Washington State from July 2018 to March 2020. Pharmacists at participating pharmacies underwent a 1-hour training on medication abortion. We approached patients who had already been evaluated, counseled, and consented for medication abortion per standard of care. Patients interested in study participation gave consent, and the clinician electronically sent a prescription to the pharmacy for mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 800 micrograms buccally. Participants were sent web-based surveys about their experience and outcomes on days 2 and 14 after enrollment and had routine follow-up with study sites. We extracted demographic and clinical data, including abortion outcome and adverse events, from medical records. We performed multivariable logistic regression to assess the association of pharmacy experience and other covariates with satisfaction.
RESULTS
We enrolled 266 participants and obtained clinical outcome information for 262 (98.5%), of whom two reported not taking either medication. Of the 260 participants with abortion outcome information, 252 (96.9%) and 237 (91.2%) completed day 2 and 14 surveys, respectively. Complete medication abortion (primary outcome) occurred for 243 participants (93.5%, 95% CI 89.7-96.1%). Four participants (1.5%, 95% CI 0.4-3.9%) had an adverse event, none of which was serious or related to pharmacist dispensing. In the day 2 survey, 91.3% (95% CI 87.1-94.4%) of participants reported satisfaction with the pharmacy experience. In the day 14 survey, 84.4% (95% CI 79.1-88.8%) reported satisfaction with the medication abortion experience. Those reporting being very satisfied with the pharmacy experience had higher odds of reporting overall satisfaction with medication abortion (adjusted odds ratio 2.96, 95% CI 1.38-6.32).
CONCLUSION
Pharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03320057.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adolescent; Adult; California; Cohort Studies; Female; Humans; Middle Aged; Misoprostol; Pharmaceutical Services; Practice Patterns, Pharmacists'; Pregnancy; Prospective Studies; Surveys and Questionnaires; Telemedicine; Washington; Young Adult
PubMed: 33706339
DOI: 10.1097/AOG.0000000000004312 -
The Cochrane Database of Systematic... Apr 2015Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic.
OBJECTIVES
To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition.
SEARCH METHODS
In August 2014 we searched sources including the Menstrual Disorders and Subfertility Group (MDSG) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and reference lists of relevant articles. We searched for published and unpublished studies in any language.
SELECTION CRITERIA
Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment.
DATA COLLECTION AND ANALYSIS
Data extraction and quality assessment were conducted independently by two review authors. The primary review outcomes were effectiveness of cervical dilatation (defined as the proportion of women requiring mechanical cervical dilatation) and intraoperative complications. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width, abandonment of the procedure, side effects of dilating agents and duration of surgery. We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals ( CIs). Data were statistically pooled where appropriate. Heterogeneity was assessed using the I(2) statistic. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS
Nineteen RCTs with a total of 1870 participants were included. They compared misoprostol with no treatment or placebo, dinoprostone or osmotic dilators.Misoprostol was more effective for cervical dilatation than placebo or no intervention, with fewer women requiring mechanical dilatation (OR 0.08, 95% CI 0.04 to 0.16, five RCTs, 441 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 80% of women undergoing hysteroscopy require mechanical dilatation without use of preoperative ripening agents, use of misoprostol will reduce the need for mechanical dilatation to between 14% and 39%. Misoprostol was associated with fewer intraoperative complications (OR 0.37, 95% CI 0.18 to 0.77, 12 RCTs, 901 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 3% of women undergoing hysteroscopy experience intraoperative complications without use of preoperative ripening agents, use of misoprostol will reduce the risk of complications to 2% or less.When specific complications were considered, the misoprostol group had a lower rate of cervical laceration or tearing (OR 0.25, 95% CI 0.11 to 0.57, nine RCTS, 669 women, I(2)=0%, moderate quality evidence) or false track formation (OR 0.34, 95% CI 0.12 to 0.97, seven RCTs, 560 participants, I(2)=0%, moderate quality evidence). There was no evidence of a difference between the groups in rates of uterine perforation (0.42, 95% CI 0.13 to 1.38, seven RCTs, 455 participants, I(2)=0%, low quality evidence) or uterine bleeding (OR 0.51, 95% CI 0.10 to 2.49, four RCTs, 340 participants, I(2)=0%, low quality evidence). Some treatment side effects (mild abdominal pain, vaginal bleeding, and increased body temperature) were more common in the misoprostol group.Compared with dinoprostone, misoprostol was associated with more effective cervical dilatation, with fewer women requiring mechanical dilatation (OR 0.58; 95% CI 0.34 to 0.98; one RCT, 310 participants, low quality evidence) and with fewer intraoperative complications (OR 0.32; 95% CI 0.12 to 0.83, one RCT, 310 participants, low quality evidence). However treatment side effects were more common in the misoprostol arm.Compared to osmotic dilatation (laminaria), misoprostol was associated with less effective cervical dilatation, with more women in the misoprostol group requiring mechanical dilatation (OR 5.96, 95% CI 2.61 to 13.59, one RCT, 110 participants, low quality evidence). There was no evidence of a difference between misoprostol and osmotic dilators in intraoperative complication rates (OR 5.14, 95% CI 0.24 to 109.01, three RCTs, 354 participants, low quality evidence), with only two events reported altogether.The overall quality of the evidence ranged from low to moderate. The main limitations in the evidence were imprecision and poor reporting of study methods.
AUTHORS' CONCLUSIONS
There is moderate quality evidence that use of misoprostol for preoperative ripening of the cervix before operative hysteroscopy is more effective than placebo or no treatment and is associated with fewer intraoperative complications such as lacerations and false tracks. However misoprostol is associated with more side effects, including preoperative pain and vaginal bleeding. There is low quality evidence to suggest that misoprostol has fewer intraoperative complications and is more effective than dinoprostone.There is also low quality evidence to suggest that laminaria may be more effective than misoprostol, with uncertain effects for complication rates. However the possible benefits of laminaria need to be weighed against the inconvenience of its insertion and retention for one to two days.
Topics: Cervical Ripening; Cervix Uteri; Dilatation; Dinoprostone; Female; Humans; Hysteroscopy; Laminaria; Misoprostol; Oxytocics; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic
PubMed: 25906113
DOI: 10.1002/14651858.CD005998.pub2 -
BMJ Open Gastroenterology Jun 2024The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been reported to decrease proinflammatory cytokine production and may have a potential role in treating NASH. We aimed to evaluate the efficacy and safety of misoprostol in treating patients with NASH.
METHODS
In this phase 2, double-blind, randomised, placebo-controlled trial, patients with NASH were randomly assigned in a 1:1 ratio to receive 200 µg of misoprostol or placebo thrice daily for 2 months. The primary endpoint was an improvement in liver function tests (LFTs), interleukin-6 (IL-6) and endotoxin levels. The secondary endpoint was improvement in insulin resistance, dyslipidaemia, hepatic fibrosis and hepatic steatosis.
RESULTS
A total of 50 patients underwent randomisation, of whom 44 (88%) were males. The age range was 25-64 years (mean±SE of mean (SEM) 38.1±1.4). 19 (38%) patients had concomitant type 2 diabetes mellitus. 32 (64%) patients were either overweight or obese. At the end of 2 months' treatment, a reduction in total leucocyte count (TLC) (p=0.005), alanine aminotransferase (ALT) (p<0.001), aspartate aminotransferase (AST) (p=0.002) and controlled attenuation parameter (CAP) (p=0.003) was observed in the misoprostol group, whereas placebo ensued a decline in ALT (p<0.001), AST (p=0.018), gamma-glutamyl transferase (GGT) (p=0.003), CAP (p=0.010) and triglycerides (p=0.048). There was no diminution in insulin resistance, hepatic fibrosis (elastography) and dyslipidaemia in both groups. However, misoprostol resulted in a significant reduction in CAP as compared with the placebo group (p=0.039). Moreover, in the misoprostol group, pretreatment and post-treatment IL-6 and endotoxin levels remained stable, while in the placebo group, an increase in the IL-6 levels was noted (p=0.049). Six (12%) patients had at least one adverse event in the misoprostol group, as did five (10%) in the placebo group. The most common adverse event in the misoprostol group was diarrhoea. No life-threatening events or treatment-related deaths occurred in each group.
CONCLUSION
Improvement in the biochemical profile was seen in both misoprostol and placebo groups without any statistically significant difference. However, there was more improvement in steatosis, as depicted by CAP, in the misoprostol group and worsening of IL-6 levels in the placebo group.
TRIAL REGISTRATION NUMBER
NCT05804305.
Topics: Humans; Male; Female; Non-alcoholic Fatty Liver Disease; Middle Aged; Double-Blind Method; Adult; Misoprostol; Interleukin-6; Treatment Outcome; Insulin Resistance; Liver Cirrhosis; Liver Function Tests; Liver
PubMed: 38844374
DOI: 10.1136/bmjgast-2023-001342 -
BMJ Open Jan 2021To assess access (availability and affordability) to oxytocin and misoprostol at health facilities in Kenya, Uganda and Zambia to improve prevention and management of...
Access to oxytocin and misoprostol for management of postpartum haemorrhage in Kenya, Uganda and Zambia: a cross-sectional assessment of availability, prices and affordability.
OBJECTIVE
To assess access (availability and affordability) to oxytocin and misoprostol at health facilities in Kenya, Uganda and Zambia to improve prevention and management of postpartum haemorrhage (PPH).
DESIGN
The assessment was undertaken using data from Health Action International (HAI) research on sexual and reproductive health commodities based on a cross-sectional design adapted from the standardised WHO/HAI methodology.
SETTING
Data were collected from 376 health facilities in in Kenya, Uganda and Zambia in July and August 2017.
OUTCOME MEASURES
Availability was calculated as mean percentage of sampled medicine outlets where medicine was found on the day of data collection. Medicine prices were compared with international reference prices (IRP) and expressed as median price ratios. Affordability was calculated using number of days required to pay for a standard treatment based on the daily income of the lowest paid government worker.
RESULTS
Availability of either oxytocin or misoprostol at health facilities was high; 81% in Kenya, 82% in Uganda and 76% in Zambia. Oxytocin was more available than misoprostol, and it was most available in the public sector in the three countries. Availability of misoprostol was highest in the public sector in Uganda (88%). Oxytocin and misoprostol were purchased by patients at prices above IRP, but both medicines cost less than a day's wages and were therefore affordable. Availability of misoprostol was poor in rural settings where it would be more preferred due to lack of trained personnel and cold storage facilities required for oxytocin.
CONCLUSION
Availability and affordability of either oxytocin or misoprostol at health facilities met the WHO benchmark of 80%. However, countries with limited resources should explore mechanisms to optimise management of PPH by improving access to misoprostol especially in rural areas.
Topics: Costs and Cost Analysis; Cross-Sectional Studies; Drugs, Essential; Female; Health Services Accessibility; Humans; Kenya; Misoprostol; Oxytocin; Postpartum Hemorrhage; Pregnancy; Private Sector; Uganda; Zambia
PubMed: 33414148
DOI: 10.1136/bmjopen-2020-042948 -
PloS One 2020Misoprostol is listed in the WHO essential medicines list and can be used for induction of labour, for prevention and treatment of post-partum haemorrhage, and for...
Misoprostol is listed in the WHO essential medicines list and can be used for induction of labour, for prevention and treatment of post-partum haemorrhage, and for abortions. The compound is unstable, and substandard misoprostol preparations have been detected in low- and middle-income countries. We now investigated the stability of misoprostol tablets according to the international guidelines for stability testing of pharmaceutical products. Three brands (four batches) of misoprostol tablets were collected in Malawi and Rwanda: the originator product, a WHO-prequalified product, and a generic product without WHO prequalification. A further batch of the originator product was collected in Germany. To investigate the effect of damage to the primary packaging, additional blister strips of one sample were intentionally damaged with a needle and investigated in parallel. Samples were placed in stability chambers for six months at 40°C/75% relative humidity (RH) and at 25°C/60% RH. After 0, 1, 2, 3 and 6 months, misoprostol content was determined according to the International Pharmacopeia. At 40°C/75% RH, all samples showed a decline of misoprostol content, but four of the batches still remained within the pharmacopeial specifications, while one of the two batches of the generic product without WHO-prequalification showed a final content of 86.2% which is out of specifications. Damage to the primary packaging greatly decreased stability, resulting in a final content of only 48.2% of the declared misoprostol amount. At 25°C/60% RH all samples remained in specifications for six months, even the sample with the damaged blister. Dissolution of misoprostol remained in specifications of the pharmacopoeia for six months for all batches, except for the sample with damaged blisters stored at 40°C/75% RH. This study confirms that the stability of misoprostol tablets must be ensured by intact, good-quality primary packaging. Careful supplier qualification is required in the procurement process.
Topics: Chromatography, High Pressure Liquid; Drug Packaging; Drug Stability; Humidity; Malawi; Misoprostol; Rwanda; Tablets; Temperature
PubMed: 32877459
DOI: 10.1371/journal.pone.0238628 -
Zhejiang Da Xue Xue Bao. Yi Xue Ban =... Feb 2023To investigate influencing factors of intrapartum fever during vaginal delivery and to construct a prediction model for infectious intrapartum fever.
OBJECTIVES
To investigate influencing factors of intrapartum fever during vaginal delivery and to construct a prediction model for infectious intrapartum fever.
METHODS
A total of 444 patients with intrapartum fever admitted in Ningbo Women and Children's Hospital from January 2020 to December 2021 were enrolled. The clinical data and laboratory findings were compared between patients with infectious intrapartum fever and non-infectious intrapartum fever, and the factors associated with intrapartum fever were analyzed with a multivariate logistic regression model. A prediction nomogram model was constructed based on the factors of intrapartum fever and its predictive efficiency was evaluated by correction curve and receiver operator characteristic curve.
RESULTS
In the 444 cases, 182 (41.0%) had definite intrauterine infection and 262 (59.0%) had no infectious intrapartum fever. Univariate analysis showed that the length of hospital stay before induced labor, the time of induced abortion, misoprostol administration, autoimmune diseases, white blood cell count (WBC) and hypersensitive C-reactive protein (hs-CRP) levels were significantly different between the two groups (all <0.05). Multivariate analysis showed that misoprostol administration and autoimmune diseases were protective factors (=0.31 and 0.36, both <0.05) for infectious intrapartum fever, while high WBC and hs-CRP were risk factors (=1.20 and 1.09, both <0.05). The area under the curve of nomogram model for predicting infectious intrapartum fever was 0.823, and the calibration curve validation showed that the predicted and measured values were in general agreement.
CONCLUSIONS
Multiple factors cause intrapartum fever. The nomogram model constructed in this study has good predictive accuracy for infectious intrapartum fever.
Topics: Pregnancy; Child; Humans; Female; Nomograms; C-Reactive Protein; Misoprostol; Retrospective Studies; Leukocyte Count
PubMed: 37283118
DOI: 10.3724/zdxbyxb-2022-0479