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Obstetrics and Gynecology Mar 2024Early pregnancy loss (EPL) is common, but patients face barriers to the most effective medication (mifepristone followed by misoprostol) and procedural (uterine...
Early pregnancy loss (EPL) is common, but patients face barriers to the most effective medication (mifepristone followed by misoprostol) and procedural (uterine aspiration) management options. This cross-sectional geospatial analysis evaluated access in New Mexico to mifepristone and misoprostol and uterine aspiration in emergency departments (comprehensive) and to uterine aspiration anywhere in a hospital (aspiration) for EPL. Access was defined as a 60-minute car commute. We collected data from hospital key informants and public databases and performed logistical regression to evaluate associations between access and rurality, area deprivation, race, and ethnicity. Thirty-five of 42 (83.3%) hospitals responded between October 2020 and August 2021. Two hospitals (5.7%) provided comprehensive management; 24 (68.6%) provided aspiration. Rural and higher deprivation areas had statistically significantly lower adjusted odds ratios for comprehensive management (0.03-0.07 and 0.3-0.4, respectively) and aspiration (0.03-0.06 and 0.1-0.3, respectively) access. Mifepristone and uterine aspiration implementation would address disparate access to EPL treatment.
Topics: Pregnancy; Female; Humans; Mifepristone; Abortion, Spontaneous; Misoprostol; Abortion, Induced; Cross-Sectional Studies; Respiratory Aspiration
PubMed: 38207328
DOI: 10.1097/AOG.0000000000005505 -
BMC Research Notes Oct 2023The complications associated with miscarriages have surfaced as a major concern in maintaining women's physical and mental health. The present study evaluated the... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The complications associated with miscarriages have surfaced as a major concern in maintaining women's physical and mental health. The present study evaluated the efficacy of three medication regimes for the complete expulsion of retained intrauterine tissues in patients who underwent a miscarriage.
METHODS
In this randomized clinical trial, 90 patients participated with their gestational age below 12 weeks, each having undergone a recent miscarriage. After being screened for underlying diseases and coagulative blood disorders, they were randomly allocated into three groups. For the first group, labeled as the control group, misoprostol was administered alone. In contrast, the combination of misoprostol plus methylergometrine and misoprostol plus oxytocin was prescribed for the second and third groups, respectively. Further, the data obtained were analyzed by descriptive and inferential statistics using Stata software version 14.
RESULTS
The mean age of participants and gestational age were 29.76 ± 5.53 years and 8.23 ± 2.29 weeks, respectively. There was no significant difference between the three treatment groups regarding the amount of bleeding after the abortion(P = 0.627). Regarding pain severity, the group that received Misoprostol plus Methylergometrine had less pain intensity than the other two groups(p = 0.004). The mean rate of RPOC expulsion was in the Misoprostol plus Oxytocin (9.68 ± 10.36) group, Misoprostol plus Methylergometrine (11.73 ± 12.86), and Misoprostol groups (19.07 ± 14.31)(p = 0.013). The success rate in outpatient medical abortion in the misoprostol plus oxytocin and misoprostol plus methylergonovine group was 93.33%, but in patients treated by misoprostol alone was 83.33%.
CONCLUSION
The effectiveness of the drugs in the two drug groups combined with oxytocin and methylergometrine is higher than the misoprostol group alone. An outpatient approach was deemed more satisfactory against surgical maneuvers and hospitalizations by patients since family support influenced their pain coping mechanism.
TRIAL REGISTRATION
The trial was registered in the Iranian registry of clinical trials on 04/10/2019. ( https://fa.irct.ir/trial/34519 ; registration number: IRCT20150407021653N19).
Topics: Pregnancy; Humans; Female; Young Adult; Adult; Infant; Misoprostol; Oxytocin; Methylergonovine; Oxytocics; Abortion, Spontaneous; Outpatients; Iran; Abortion, Induced
PubMed: 37798748
DOI: 10.1186/s13104-023-06509-6 -
Pharmacology 2021Postpartum hemorrhage (PPH) remains a common cause of maternal mortality worldwide. Medical intervention plays an important role in the prevention and treatment of PPH.... (Review)
Review
BACKGROUND
Postpartum hemorrhage (PPH) remains a common cause of maternal mortality worldwide. Medical intervention plays an important role in the prevention and treatment of PPH. Prostaglandins (PGs) are currently recommended as second-line uterotonics, which are applied in cases of persistent bleeding despite oxytocin treatment.
SUMMARY
PG agents that are constantly used in clinical practice include carboprost, sulprostone, and misoprostol, representing the analogs of PGF2α, PGE2, and PGE1, respectively. Injectable PGs, when used to treat PPH, are effective in reducing blood loss but probably induce cardiovascular or respiratory side effects. Misoprostol is characterized by oral administration, low cost, stability in storage, broad availability, and minimal side effects. It remains a treatment option for uterine atony in low-resource settings, but its effectiveness as a uterotonic for independent application may be limited. Key Messages: The present review article discusses the physiological roles of various natural PGs, evaluates the existing evidence of PG analogs in the prevention and treatment of PPH, and finally provides a reference to assist obstetricians in selecting appropriate uterotonics.
Topics: Carboprost; Dinoprostone; Drug Administration Routes; Drug Stability; Female; Humans; Misoprostol; Postpartum Hemorrhage; Prostaglandins; Receptors, Prostaglandin; Uterus
PubMed: 34237742
DOI: 10.1159/000516631 -
BJOG : An International Journal of... Aug 2021To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage.
DESIGN
Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS).
SETTING
Twenty-eight UK NHS early pregnancy units.
SAMPLE
A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage.
METHODS
Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets.
MAIN OUTCOME MEASURES
Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs).
RESULTS
For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management.
CONCLUSIONS
The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage.
TWEETABLE ABSTRACT
The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.
Topics: Abortifacient Agents; Abortion, Missed; Adolescent; Adult; Cost-Benefit Analysis; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Young Adult
PubMed: 33969614
DOI: 10.1111/1471-0528.16737 -
BJOG : An International Journal of... Jul 2022Increasingly, births around the world are started artificially using medications or other methods. This process is known as induction of labour. As it becomes more... (Review)
Review
Increasingly, births around the world are started artificially using medications or other methods. This process is known as induction of labour. As it becomes more common, methods are needed to meet the different clinical needs and birth preferences of women. Induction of labour typically includes a combination of the medication dinoprostone inserted into the vagina, artificial rupture of membranes ('releasing the waters'), and synthetic oxytocin (hormone given via a drip). This paper reviews some of the methods less commonly used for induction in the UK, namely a drug called misoprostol, which can be given orally or vaginally, and 'mechanical' methods, where labour is started by stretching the cervix (neck of the womb), most commonly with a soft silicone tube with a balloon near the tip, filled with water. Low-dose oral misoprostol tablets are now commercially available in the UK. Other methods for labour induction are not reviewed in detail in this paper. The evidence suggests mechanical induction of labour (using a balloon catheter) and misoprostol are both at least as safe and effective as using the standard drug, dinoprostone. There is evidence to suggest a balloon catheter may reduce the chance of serious negative outcomes for babies when compared with dinoprostone, and that giving low-dose oral misoprostol results in fewer caesarean births. Where possible and after informed consent, the method of induction of labour should be personalised to suit the individual woman, her clinical condition, and the setting in which she is giving birth. Local contexts and resources also need to be taken into account. To date, research into women's perspectives and experiences of induction of labour have been significantly lacking.
Topics: Administration, Intravaginal; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pregnancy
PubMed: 35478481
DOI: 10.1111/1471-0528.17136 -
Contraception Sep 2019To evaluate outcomes with mifepristone 200 mg orally followed 24-48 h later by misoprostol 800 mcg vaginally for medical abortion at 64-70 days of gestation.
OBJECTIVE
To evaluate outcomes with mifepristone 200 mg orally followed 24-48 h later by misoprostol 800 mcg vaginally for medical abortion at 64-70 days of gestation.
STUDY DESIGN
We reviewed electronic databases and medical records for medical abortion cases at 64-70 days' gestation at British Pregnancy Advisory Service clinics in England and Wales from May 2015 through October 2016. Women selected in-office follow-up or self-evaluation of abortion outcome using a checklist along with low-sensitivity urine pregnancy testing. We excluded cases in which we could not locate records and when women did not proceed with medical abortion, did not use misoprostol following mifepristone if abortion had not occurred and did not attend a scheduled follow-up assessment. We analyzed demographic characteristics, treatment outcomes and significant adverse events. We defined treatment success as complete abortion without surgical evacuation and without continuing pregnancy.
RESULTS
Of 2743 cases identified, we could not locate 40 charts and excluded 30 cases, leaving a final sample of 2673. Overall, 2538 (94.9%, 95% CI 94.1-95.8) women had a successful medical abortion. Reasons for failure included continuing pregnancy (n=90, 3.4%, 95% CI 2.7-4.1), retained nonviable pregnancy (n=2, 0.1%, 95% CI 0-0.2) and incomplete abortion (n=43, 1.6%, 95% CI 1.1-2.1). Of those with continuing pregnancies, 81 underwent a uterine aspiration and 9 opted to continue the pregnancy. Thirty-five (1.3%, 95% CI 0.9-1.7) women had significant adverse events; 16 (0.6%, 95% CI 0.3-0.9) underwent an in-hospital aspiration. Pelvic infection (n=4, 0.2%) and transfusion (n=1, 0.03%) occurred rarely.
CONCLUSION
Medical abortion from 64 to 70 days with mifepristone and vaginal misoprostol is effective with a low rate of serious adverse events.
IMPLICATIONS
Medical abortion between 64 and 70 days of gestation may be offered on an outpatient basis using mifepristone and vaginal misoprostol. Service provision without an in-person follow-up is feasible. Not all women with a continuing pregnancy after medical abortion treatment opt to have an aspiration procedure.
Topics: Abortifacient Agents; Abortion, Incomplete; Abortion, Induced; Administration, Intravaginal; Administration, Oral; Adolescent; Adult; Drug Therapy, Combination; Female; Humans; Middle Aged; Mifepristone; Misoprostol; Patient Satisfaction; Pregnancy; Pregnancy Trimester, First; Treatment Outcome; United Kingdom; Young Adult
PubMed: 31102629
DOI: 10.1016/j.contraception.2019.05.006 -
Contraception Oct 2021Document the effectiveness and safety of Foley balloon catheter and misoprostol use for cervical preparation before a same-day dilation and evacuation (D&E).
OBJECTIVE
Document the effectiveness and safety of Foley balloon catheter and misoprostol use for cervical preparation before a same-day dilation and evacuation (D&E).
STUDY DESIGN
We conducted a retrospective medical records review of adult patients with viable pregnancies at 18 weeks 0 days to 21 weeks 6 days gestation who received a same-day D&E at an Alabama clinic using a 30-cc Foley balloon catheter and misoprostol for cervical preparation from January 2016 through December 2017. Patients received misoprostol 800 mcg buccally at the time of Foley placement and then every 4 hours until the physician deemed that dilation/effacement was adequate to proceed with a D&E. We extracted patient demographics, pregnancy and medical history, and preoperative, intraoperative, and postoperative data. We primarily evaluated effectiveness (D&E completion within one procedure day). Our secondary outcomes included safety, time between misoprostol and procedure start time, length of D&E, recovery time, and number of doses of misoprostol provided.
RESULTS
Two hundred and ninety patient charts met our review criteria - all of whom had a complete abortion in one day. Only one safety incident, a cervical laceration, occurred (0.3% of all procedures). The median time between Foley placement and first misoprostol dose and the procedure start was 7.2 hours (2.9-12.6 hours; interquartile range [IQR] 6.2-8.4 hours); median procedure length was 12 minutes (2-40 minutes; IQR 10-15 minutes); and median recovery time 14 minutes (4-89 minutes; IQR 14-16 minutes). Most patients needed two doses of misoprostol (n = 258, 89%), and 11 (4%) needed three doses; 21 (7%) patients needed one dose of misoprostol.
CONCLUSION
Patients in the mid-second trimester can effectively and safely undergo cervical preparation with a Foley balloon catheter and misoprostol to facilitate completion of same-day D&E.
IMPLICATIONS
Foley balloon catheter use with misoprostol for cervical preparation for second-trimester abortion (the Robinson Foley protocol) is effective and safe and can be completed in one day when used by an experienced physician.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Catheters; Female; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, Second; Retrospective Studies
PubMed: 34174293
DOI: 10.1016/j.contraception.2021.06.015 -
American Journal of Obstetrics &... Dec 2023Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Pregnancies at high risk for maternal, fetal, or placental complications often necessitate induction of labor in the late preterm or early term period for delivery. Limited data exist on the safest method of induction to use in this specific patient population.
OBJECTIVE
This study aimed to compare the combination of oxytocin plus a Cook balloon vs misoprostol plus a Cook balloon for induction of labor in high-risk pregnancies.
STUDY DESIGN
We conducted an open-label, randomized controlled trial at a single institution from July 2020 to May 2022. The study was approved by the institutional review board and registered with ClinicalTrials.gov (NCT04492072). Individuals with a high-risk pregnancy, at least ≥22 weeks' gestation, with a singleton in cephalic presentation, Bishop score ≤6, and intact membranes were offered enrollment. A high-risk pregnancy was defined as a pregnancy with any of the following complications: hypertensive disease of pregnancy, fetal growth restriction, oligohydramnios, suspected placental abruption requiring delivery, uncontrolled pregestational diabetes, or abnormal biophysical profile or nonstress test requiring delivery. The primary outcome was the rate of cesarean delivery. Secondary maternal outcomes included induction to delivery interval, number of vaginal deliveries within 24 hours, rates of uterine tachysystole, intraamniotic infection, operative vaginal delivery, and postpartum hemorrhage. Secondary fetal outcomes included fetal heart rate abnormalities, stillbirth, Apgar scores <7 at 5 minutes, admission to the neonatal intensive care unit, arterial umbilical blood pH <7.1, sepsis, and neonatal death. A subgroup analysis was planned for the primary outcome to assess the different indications for cesarean delivery. An intent-to-treat analysis was performed.
RESULTS
During the 22 months of the trial, a total of 150 patients were randomized, and 73 (49%) of those were induced with oxytocin and a Cook balloon and 77 (51%) were induced with misoprostol and a Cook balloon. There was no significant difference in the overall rate of cesarean delivery between the study groups, (21.9% vs 31.1%; relative risk, 0.70; 95% confidence interval, 0.41-1.21), nor among those for which the cesarean delivery was performed for a specific indication. There were no differences in the secondary maternal and fetal or neonatal adverse outcomes.
CONCLUSION
In high-risk pregnancies, the rate of cesarean delivery and adverse maternal and fetal outcomes were similar for induction of labor with oxytocin and a Cook balloon and for induction with misoprostol and a Cook balloon.
Topics: Infant, Newborn; Pregnancy; Humans; Female; Misoprostol; Oxytocin; Oxytocics; Pregnancy, High-Risk; Labor, Induced; Placenta; Cervical Ripening
PubMed: 37806650
DOI: 10.1016/j.ajogmf.2023.101175 -
BMC Health Services Research Mar 2023Low- and middle-income countries (LMICs) are committed to achieving the Sustainable Development Goal 3.1 to reduce maternal mortality. The Ministry of Health and Family...
Cost-effectiveness and budget impact of heat-stable carbetocin compared to oxytocin and misoprostol for the prevention of postpartum hemorrhage (PPH) in women giving birth in India.
INTRODUCTION
Low- and middle-income countries (LMICs) are committed to achieving the Sustainable Development Goal 3.1 to reduce maternal mortality. The Ministry of Health and Family Welfare of India recommends prophylactic uterotonic administration to every woman following delivery to reduce the risk of postpartum hemorrhage (PPH), as PPH is the leading cause of maternal mortality in LMICs, including India. In 2018, the World Health Organization first recognized heat-stable carbetocin for PPH prevention. Governments are now considering its introduction into their public health systems.
METHODS
A decision-tree model was developed from the public healthcare system perspective to compare the value of heat-stable carbetocin versus oxytocin and misoprostol among women giving birth in public sector healthcare facilities in India. The model accounted for differences in PPH risk and costs based on mode of delivery and healthcare setting, as well as provider behavior to mitigate quality concerns of oxytocin. Model outcomes for each prophylactic uterotonic included the number of PPH events, DALYs due to PPH, deaths due to PPH, and direct medical care costs. The budget impact was estimated based on projected uterotonic uptake between 2022-2026.
RESULTS
Compared to oxytocin, heat-stable carbetocin avoided 5,468 additional PPH events, 5 deaths, and 244 DALYs per 100,000 births. Projected direct medical costs to the public healthcare system were lowered by US $171,700 (₹12.8 million; exchange rate of ₹74.65 = US$1 from 2 Feb 2022) per 100,000 births. Benefits were even greater when compared to misoprostol (7,032 fewer PPH events, 10 fewer deaths, 470 fewer DALYs, and $230,248 saved per 100,000 births). In the budget impact analysis, India's public health system is projected to save US$11.4 million (₹849 million) over the next five years if the market share for heat-stable carbetocin grows to 19% of prophylactic uterotonics administered.
CONCLUSIONS
Heat-stable carbetocin is expected to reduce the number of PPH events and deaths, avoid more DALYs, and reduce costs to the public healthcare system of India. Greater adoption of heat-stable carbetocin for the prevention of PPH could advance India's efforts to achieve its maternal health goals and increase efficiency of its public health spending.
Topics: Pregnancy; Female; Humans; Oxytocin; Postpartum Hemorrhage; Misoprostol; Oxytocics; Cost-Benefit Analysis; Hot Temperature; India
PubMed: 36932411
DOI: 10.1186/s12913-023-09263-4 -
The American Journal of Emergency... Nov 2022On June 24, 2022, the Supreme Court overturned Roe v. Wade, which will limit legal abortion in many areas of the U.S. Over half of abortions in the U.S. are performed... (Review)
Review
BACKGROUND
On June 24, 2022, the Supreme Court overturned Roe v. Wade, which will limit legal abortion in many areas of the U.S. Over half of abortions in the U.S. are performed using medication as opposed to surgical techniques. With widespread access to agents that are used for medication abortion, there may be an increase in emergency department presentations related to improper or unsupervised use of these medications.
METHODS
This narrative review focuses on the contraindications, adverse effects, and toxicities of the most common agents used for medication abortion in the U.S.
RESULTS
Medications included in this review are mifepristone, misoprostol, and methotrexate. Each of these medications has a unique adverse effect and toxicity profile.
CONCLUSION
Agents used for medication abortion have unique contraindications and adverse effects. Improper or unsupervised use may occur in the setting of limited abortion access and emergency medicine physicians are on the front lines in managing these presentations.
Topics: Humans; Pregnancy; Female; United States; Abortifacient Agents; Mifepristone; Misoprostol; Methotrexate; Abortion, Induced; Physicians
PubMed: 36007432
DOI: 10.1016/j.ajem.2022.08.027