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Nigerian Journal of Clinical Practice Feb 2024Intrauterine foetal death (IUFD) is an unpleasant pregnancy outcome and prompt delivery of the dead foetus is usually desired by mothers. Unfortunately, spontaneous... (Randomized Controlled Trial)
Randomized Controlled Trial
A Comparison of the Efficacy and Safety of Mifepristone and Misoprostol Versus Misoprostol alone for Induction of Labour in Nigerian Women with Intrauterine Fetal Death: A Triple Blind Randomized Controlled Trial.
BACKGROUND
Intrauterine foetal death (IUFD) is an unpleasant pregnancy outcome and prompt delivery of the dead foetus is usually desired by mothers. Unfortunately, spontaneous labour and delivery may not occur early and prolonged retention of the dead foetus in utero is life-threatening. Many of the agents currently used for the induction of labour may result in a prolonged delivery process.
OBJECTIVES
To compare the efficacy and safety of mifepristone and misoprostol versus misoprostol alone for induction of labour in women with intrauterine foetal death.
MATERIALS AND METHODS
This was a triple-blind randomized controlled trial. Eighty women were randomized into two groups. The intervention group received a single oral dose of 200 mg mifepristone, followed by 6-hourly 50 μg misoprostol vaginal insertion, after 24-hour intervals. The control group received a placebo, followed by 6-hourly 50 μg misoprostol vaginal insertion, after 24-hour intervals. The primary outcome measure was the induction to delivery interval.
RESULTS
Maternal age, gestational age, parity and pre-induction bishop's score were comparable between the two groups. The mean induction to the delivery interval in the intervention group was significantly less in the intervention group than the control group (18.78 ± 6.51 hours versus 37.10 ± 10.10; P < 0.001). The total dose of misoprostol required for induction of labour; the need for oxytocin augmentation of labour; and the observed side effects of misoprostol were all significantly less in intervention group than control group (P < 0.001; P < 0.01; and P = 0.03, respectively).
CONCLUSION
The combination of mifepristone and misoprostol has greater efficacy and better safety profile than the use of misoprostol alone for induction of labour. This combination should be considered when induction of labour is indicated for IUFD.
Topics: Female; Humans; Pregnancy; Administration, Intravaginal; Fetal Death; Labor, Induced; Mifepristone; Misoprostol; Oxytocics; Pregnancy Outcome; Drug Combinations
PubMed: 38409142
DOI: 10.4103/njcp.njcp_786_22 -
Medicine Feb 2024Uterine prolapse is a rare complication of pregnancy, and there is still no consensus on the choice of delivery method.
BACKGROUND
Uterine prolapse is a rare complication of pregnancy, and there is still no consensus on the choice of delivery method.
METHODS
The patient's reproductive history included an abortion and eutocic delivery of a girl weighing 3200 g; the current pregnancy was the third pregnancy. Her cervical region was outside the vaginal opening and was red in color, with evident enlargement (6 × 4 cm) and a broken surface. The cervical area also showed white discharge. According to her Transvaginal ultrasonography revealed a fetus in the uterine cavity at approximately 19 weeks of gestation. Gynecological examination revealed prolapse of both the anterior and posterior vaginal walls. Evaluation of the pelvic organ prolapse-Q scores showed that the patient had uterine prolapse at stage IV.
RESULTS
Vaginal delivery was performed smoothly after oral administration mifepristone and misoprostol tablets for a few days, obtaining a dead female fetus in cephalic, 25 cm in length. The cervix of the pregnant woman did not prolapse during the delivery.
CONCLUSION
For pregnancy with uterine prolapse and cervical incarceration, transvaginal delivery is a potential treatment option. Maintenance of cervical retraction and oral mifepristone administration with misoprostol tablets is crucial during this delivery. This treatment can minimize the risk of cervical lacerations and uterine rupture, helping surgeons to complete the operation successfully.
Topics: Humans; Pregnancy; Female; Misoprostol; Pregnancy Trimester, Second; Mifepristone; Uterine Prolapse; Cervix Uteri; Incarceration; Delivery, Obstetric
PubMed: 38363949
DOI: 10.1097/MD.0000000000037202 -
Nature Medicine Apr 2024Telehealth abortion has become critical to addressing surges in demand in states where abortion remains legal but evidence on its effectiveness and safety is limited....
Telehealth abortion has become critical to addressing surges in demand in states where abortion remains legal but evidence on its effectiveness and safety is limited. California Home Abortion by Telehealth (CHAT) is a prospective study that follows pregnant people who obtained medication abortion via telehealth from three virtual clinics operating in 20 states and Washington, DC between April 2021 and January 2022. Individuals were screened using a standardized no-test protocol, primarily relying on their medical history to assess medical eligibility. We assessed effectiveness, defined as complete abortion after 200 mg mifepristone and 1,600 μg misoprostol (or lower) without additional intervention; safety was measured by the absence of serious adverse events. We estimated rates using multivariable logistic regression and multiple imputation to account for missing data. Among 6,034 abortions, 97.7% (95% confidence interval (CI) = 97.2-98.1%) were complete without subsequent known intervention or ongoing pregnancy after the initial treatment. Overall, 99.8% (99.6-99.9%) of abortions were not followed by serious adverse events. In total, 0.25% of patients experienced a serious abortion-related adverse event, 0.16% were treated for an ectopic pregnancy and 1.3% abortions were followed by emergency department visits. There were no differences in effectiveness or safety between synchronous and asynchronous models of care. Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care.
Topics: Pregnancy; Female; Humans; United States; Prospective Studies; Abortion, Induced; Mifepristone; Misoprostol; Abortion, Spontaneous; Telemedicine
PubMed: 38361123
DOI: 10.1038/s41591-024-02834-w -
Archives of Iranian Medicine Apr 2023Some recent trials have reported high efficacy for nonsteroidal anti-inflammatory drugs (NSAIDs) in relieving medical abortion-related pain. The aim of this study was to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Some recent trials have reported high efficacy for nonsteroidal anti-inflammatory drugs (NSAIDs) in relieving medical abortion-related pain. The aim of this study was to determine the beneficial effect of oral NSAIDs (ibuprofen lysine) in reduction of pain and hemorrhage in first-trimester medical abortion.
METHODS
This randomized triple-blinded clinical trial was performed on 98 pregnant women who were candidate for medical abortion within the first-trimester period (gestational age<12 weeks). The participants were randomly assigned to receive ibuprofen lysine (684 mg orally every 4 hours) or placebo. All patients were initially treated with misoprostol (800 µg every 3 hours). Pain intensity and rate of hemorrhage were assessed every hour up to 15 hours after receiving the first dose of misoprostol by visual analogue scaling (VAS) and pictorial blood loss assessment chart (PBAC), respectively.
RESULTS
Assessing the mean pain score within 15 hours of receiving misoprostol showed significantly lower pain intensity within the first 10 hours of assessment in the group receiving NSAID in comparison with the control group (<0.001). The bleeding rate was also significantly lower in the NSAID group at the fifth (=0.013) and ninth (=0.040) hour of receiving misoprostol compared to the control group. We found no difference in abortion-related complication rate between the NSAID and placebo groups (8.3% versus 8.0%, =0.952).
CONCLUSION
The use of NSAIDs (ibuprofen lysine) is a good pharmacological analgesic option for relieving medical abortionrelated pain and hemorrhage.
Topics: Pregnancy; Female; Humans; Infant; Ibuprofen; Misoprostol; Pregnancy Trimester, First; Lysine; Pain; Anti-Inflammatory Agents, Non-Steroidal; Abortion, Induced; Double-Blind Method
PubMed: 38301081
DOI: 10.34172/aim.2023.32 -
JNMA; Journal of the Nepal Medical... Sep 2023Induction of labour is the artificial initiation of uterine contraction by various means such as medical, surgical or mechanical with the aim of achieving vaginal...
INTRODUCTION
Induction of labour is the artificial initiation of uterine contraction by various means such as medical, surgical or mechanical with the aim of achieving vaginal delivery. Misoprostol, a prostaglandin E1 analogue is used popularly for the induction of labour in resource-limited health centres. The aim of the study was to find out the prevalence of induction of labour among pregnant women in the Department of Obstetrics and Gynaecology in a tertiary care centre.
METHODS
A descriptive cross-sectional study was conducted among pregnant women in a tertiary care centre from 3 February 2022 to 31 July 2022. Ethical approval was taken from the Institutional Review Committee. The women with a singleton pregnancy, reactive non-stress test, and adequate pelvis were included. Women with malpresentation, previous cesarean section, placenta previa, and cephalopelvic disproportion were excluded. Convenience sampling method was used. The point estimate was calculated at a 95% Confidence Interval.
RESULTS
Among 1355 pregnant women, the prevalence of induction of labour was found to be 135 (9.96%) (8.37-11.55, 95% Confidence Interval).
CONCLUSIONS
The prevalence of induction of labour among pregnant women was found to be similar to other studies done in similar settings.
KEYWORDS
induction of labour; misoprostol; pregnancy.
Topics: Pregnancy; Female; Humans; Misoprostol; Oxytocics; Pregnant Women; Labor, Induced; Gynecology; Cesarean Section; Cross-Sectional Studies; Tertiary Care Centers; Labor, Obstetric
PubMed: 38289805
DOI: 10.31729/jnma.8255 -
Fertility and Sterility May 2024To compare the success rates of medical management using a combined mifepristone and misoprostol protocol in cases of early pregnancy loss (EPL) between women who... (Comparative Study)
Comparative Study
OBJECTIVE
To compare the success rates of medical management using a combined mifepristone and misoprostol protocol in cases of early pregnancy loss (EPL) between women who conceived without medical assistance and those who conceived through in vitro fertilization (IVF), after fresh or frozen embryo transfer, and evaluate for the predictive factors of success, time to first passage of tissue, and time to complete resolution of pregnancy.
DESIGN
Retrospective cohort study.
SETTING
University hospital.
PATIENT(S)
Women who presented with EPL below 13 weeks of gestation between June 2013 and July 2021 who were managed medically with mifepristone 200 mg orally and misoprostol 800 mcg vaginally were included in the study.
INTERVENTION(S)
Medical management with mifepristone and misoprostol; conception without medical assistance vs. post-IVF, after fresh or frozen embryo transfer.
MAIN OUTCOME MEASURE(S)
We evaluated overall success and performed subgroup analysis according to the mode of conception and compared fresh vs. frozen-thawed embryo transfers for IVF pregnancies. In all groups, we also calculated success according to gestational age and compared the time to first passage of tissue. The potential predictive factors of treatment success were analyzed. The side effects and complications of treatment were recorded.
RESULT(S)
A total of 930 women were included in the study, 99 (11%) of whom achieved pregnancy after IVF. The overall success of medical treatment was 89% with no statistically significant difference according to the mode of conception (89% vs. 89%) or type of transfer (fresh 89% vs. frozen 89%). Only lower gestational age by sonography was independently predictive of treatment success, showing a negative regression coefficient of β = -0.333 and an odds ratio of 0.717. The mean time to first passage of tissue was 5.0 ± 2.1 hours. Altogether, 666 women (72%) showed pregnancy resolution on the day of medication administration, an additional 110 women at 1-week follow-up, and a further 74 women after ≥4 weeks on ultrasound.
CONCLUSION(S)
Medical management of EPL with mifepristone and misoprostol is a highly successful treatment option that results in completed abortion in a timely fashion in both pregnancies conceived without medical assistance and those conceived after IVF.
Topics: Humans; Female; Pregnancy; Retrospective Studies; Adult; Mifepristone; Fertilization in Vitro; Misoprostol; Abortion, Spontaneous; Embryo Transfer; Treatment Outcome; Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Administration, Oral
PubMed: 38211763
DOI: 10.1016/j.fertnstert.2024.01.011 -
Annals of the American Association of... Jan 2024is a chemical that travels. Better known as misoprostol, it was designed as a stomach ulcer drug but is now used around the world as an abortion pill due to the...
is a chemical that travels. Better known as misoprostol, it was designed as a stomach ulcer drug but is now used around the world as an abortion pill due to the self-experimentation of Latin American communities who were seeking ways to end unwanted pregnancies. We develop a chemical geography approach to misoprostol that allows us to scale inward to understand the chemical properties of this medication while also being able to scale out to understand how medicinal effects are interwoven with and determined by global politics. Misoprostol as a chemical alone does not guarantee a successful abortion and instead 'scaffolding' in the form of mobility and information is required to transform misoprostol from a chemical to a safe and effective technology of abortion. First, we examine how misoprostol is moved by feminist networks in Mexico and Peru. Second, we argue that in order to be useful it is not enough just to access the pills, information on how to use them is required. These themes culminate in our contribution of 'pharmacokinetical geographies'; the micro-geography of the placement of pharmaceuticals in and on a body and its ramifications. The chemical geographies of misoprostol tell a story of power, bodily autonomy, and resistance.
PubMed: 38204958
DOI: 10.1080/24694452.2023.2242453 -
Journal of Clinical Medicine Dec 2023The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a...
The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a dinoprostone insert (PG) alone (13.7%), cervical ripening balloon (CRB) alone (52.7%), oral misoprostol (M) alone (4.1%), or repeated methods (R, 29.5%) for gestational diabetes mellitus (GDM) at term, and to analyze maternal and neonatal morbidity outcomes according to the method for cervical ripening. After cervical ripening, vaginal delivery occurred in 84.2% (n = 123) and was similar among groups (90.0% after PG, 83.1% after CRB, 83.3% after M, and 83.7% after R; = 0.89). After a multivariable logistic regression analysis adjusted for potential confounders, the internal cervical os being open before cervical ripening was a predictor of vaginal delivery (adjusted odds ratio (OR) of 4.38, 95% confidence index (CI) of 1.62-13.3, = 0.03), and previous cesarean delivery was a predictor of cesarean delivery (aOR of 7.67, 95% CI of 2.49-24.00, < 0.01). Birthweight was also significantly associated with cesarean delivery (aOR of 1.15, 95% CI of 1.03-1.31, = 0.02). The rates of maternal and neonatal morbidity outcomes were 10.9% (n = 16) and 19.9% (n = 29), respectively, and did not differ according to the mode of delivery and to the method used for cervical ripening. Identifying these specific high-risk women (previous cesarean delivery and internal cervical os being closed before cervical ripening) for cesarean delivery among women who underwent cervical ripening for GDM at term is important and practical for all physicians to make a decision in partnership with women.
PubMed: 38202146
DOI: 10.3390/jcm13010139 -
International Journal of Pharmaceutics Feb 2024Prilling/vibration technique to produce oral microcapsules was explored to achieve local delivery of misoprostol (MIS), a prostaglandin E1 analogue indicated for the...
Prilling/vibration technique to produce oral microcapsules was explored to achieve local delivery of misoprostol (MIS), a prostaglandin E1 analogue indicated for the treatment of gastric-duodenal ulcers, at the gastric mucosa. To improve MIS chemical stability and reduce its associated systemic side effects, drug delivery systems were designed and developed as microcapsules consisting of a core of sunflower oil and MIS (F and F) or a MIS complex with hydroxypropyl-beta-cyclodextrin (HP-β-CD) (F), confirmed by specific studies, and a polymeric shell. The produced microcapsules showed high encapsulation efficiencies for those with MIS solubilized in sunflower oil (>59.86 %) and for the microcapsules with MIS/HP-β-CD (97.61 %). To demonstrate the ability of these systems to deliver MIS into the stomach, swelling and drug release experiments were also conducted in simulated gastric fluid. Among the three formulations, F showed gastric release within 30 min and was the most advantageous formulation because the presence of the MIS/HP-β-CD inclusion complex ensured a greater ability to stabilise MIS in the simulated gastric environment. In addition, these new systems have a small size (<540 µm), and good flow properties and the dose of the drug could be easily adapted using different amounts of microcapsules (flexibility), making them a passepartout for different age population groups.
Topics: Misoprostol; 2-Hydroxypropyl-beta-cyclodextrin; Capsules; Sunflower Oil; Vibration; Drug Delivery Systems; Stomach; Solubility
PubMed: 38185338
DOI: 10.1016/j.ijpharm.2023.123762