Dose Of Misoprostol Research Articles

Medical Management of Incomplete Abortion Using Pervaginal Misoprostol in Chittagong Medical College Hospital

Background: A miscarriage is a pregnancy that ends before the baby can survive outside the womb because it has not yet reached viability. A miscarriage may be early - during the first 14 weeks of pregnancy, or late. Objective of the study was to see the outcome of pervaginal misoprostol in the medical management of incomplete abortion.
 Methods: This cross-sectional study was performed between July and December 2015 on patients with incomplete abortion, who wanted to undergo medical management at the Department of Gynecology and Obstetrics, Chittagong Medical College Hospital. 100 consecutive incomplete abortion cases, who fulfilled the inclusion and exclusion criteria were enrolled for the study. Information about management with per vaginal misoprostol, possible side effects and success rate was given to the women. 600 microgram misoprostol was given per vaginally. Interval between administration of misoprostol and expulsion of product of conception was recorded.
 Result: The mean age was found 25.0±6.4 years and the mean gestational age was found 10.2±2.0 weeks. The mean duration of bleeding was found 8.6±10.9 days. No side effect was found in 86 (86%), nausea in 7(7%), vomiting in 5 (5%) and cramping in 2 (2%) patients. For majority (76%) of the patients, single dose of Misoprostol was enough to achieve the goal. However, 24 patients didn’t respond and received a second dose. The mean induction expulsion interval was 10.83±5.45 hours. Retained product of conception was found in 14 patients. Medical management failed in these 14 patients and ultimately Dilatation & Curettage (D & C) was done.
 Conclusion: Pervaginal Misoprostol is as effective as method of treating incomplete abortion at uterine size of <12 weeks. Treatment with misoprostol can reduce the demand for surgical evacuation in cases of incomplete abortion. The acceptability of misoprostol appears higher. Pervaginal Misoprostol appears suitable for the treatment of incomplete abortion in the developing countries.
 Bangladesh J Obstet Gynaecol, 2021; Vol. 36(1): 42-48

Fetal heart rate patterns and the incidence of adverse events after oral misoprostol administration for cervical ripening among low-risk pregnancies

Objective Though misoprostol is commonly used for inpatient cervical ripening, its use in outpatient settings has been limited by safety concerns. This study was conducted to assess the association between early fetal heart tracing (FHT) and maternal tocodynamometry patterns and the incidence of adverse fetal and pregnancy outcomes after the administration of oral misoprostol for cervical ripening. Methods We conducted a retrospective cohort study of 9908 low-risk patients at ≥37 weeks gestation who received oral misoprostol for cervical ripening prior to rupture of membranes between 01/01/2012 and 12/31/2017 at Kaiser Permanente Northern California hospitals as inpatients. We excluded patients who received a different agent for cervical ripening or had any need for additional inpatient monitoring, including hypertensive disorders of pregnancy, diabetes, or intrauterine growth restriction. Abnormal FHT, abnormal uterine activity, and adverse pregnancy or fetal-related events documented in the electronic health record in the four hours after administration of the first and second doses of misoprostol were assessed using descriptive statistics. Results We found that 0.9% of patients experienced tachysystole after the first dose of misoprostol (0.6% without decelerations; 0.3% with decelerations). The incidence of variable decelerations only and other FHT abnormalities (i.e. bradycardia, late or prolonged decelerations, or absent or minimal variability) in the first hour after misoprostol administration were 7.1% and 6.7% respectively, and diminished over time. The need for tocolytic use was 0.2% in the first hour and declined over time to 0.03% in the fourth hour after the first dose. Urgent cesarean delivery occurred in 0.1% of patients after receiving the first dose of misoprostol. Patients who did not experience variable, prolonged, or late decelerations in the first hour after the initial misoprostol dose were less likely to have such FHT abnormalities in the subsequent three hours compared to patients who had other FHT abnormalities (11.8% among patients with no FHT abnormalities vs. 43.7% among patients with other FHT abnormalities; p <.001). The overall trends in outcomes over time were similar after the second dose of misoprostol. Conclusion The risk of short-term adverse outcomes associated with misoprostol is low among relatively low-risk patients. FHT abnormalities occurred in up to 32% of patients in the first four hours of monitoring post-misoprostol. Patients with no FHT abnormalities in the first hour after receiving misoprostol had a low risk of developing adverse outcomes and FHT abnormalities on continued monitoring, while patients with any type of deceleration in the first hour were at higher risk of adverse outcomes and FHT abnormalities. Our data may inform the development of protocols for cervical ripening that allow reduced monitoring for a subset of low-risk patients, however, more research is needed to validate findings and develop clinical protocols.

A pilot study to compare propranolol and misoprostol versus misoprostol and placebo for induction of labor in primigravidae; a randomized, single-blinded, placebo-controlled trial

BackgroundThe Induction of labor is the most common obstetric procedure in daily practice. Introducing propranolol as a new drug to augment the action of prostaglandins will help in the induction process and decrease CS rates. Several researchers have used propranolol in the augmentation of labor.AimThis pilot study compares propranolol and misoprostol versus misoprostol alone for labor induction in primigravids.MethodsThis is a Randomized clinical trial, single-blinded, placebo-controlled trial at Ain Shams University Maternity hospital. This study included 128 pregnant full-term primigravid women candidates for labor induction, randomized into two groups. All candidates underwent labor induction with 25 µg of vaginal misoprostol. Group I received 20 mg of oral propranolol tablets, while group II received sugary pills as a placebo. Candidates who responded successfully to induction were assessed for possible augmentation of labor by amniotomy or oxytocin infusion. The Primary outcome was induction to delivery interval, while the secondary outcomes were the duration of the latent phase, mode of delivery, and APGAR score of the neonate.ResultsThe induction-delivery time was (11.8 ± 8.1 h. vs. 12.6 ± 8.9 h., P value = 0.027) and the duration of the latent phase of labor (7.9 ± 5.6 h. vs. 9.2 ± 6.03 h., P value = 0.017) were significantly shorter in the group of misoprostol and propranolol compared to the group of misoprostol and placebo. There was no statistically significant difference between both groups’ mode of delivery, indications for cesarean section, misoprostol, and oxytocin doses, or neonatal outcome. (P value > 0.05).ConclusionPropranolol, when used with misoprostol for induction of labor, results in augmentation of action of misoprostol and a significantly shorter induction-delivery interval.Trial registrationWe retrospectively registered this trial in clinicaltrial.gov on 01/09/2020 (NCT04533841). https://clinicaltrials.gov/ct2/show/NCT04533841

An analysis of misoprostol effectiveness in second trimester pregnancy terminations

Background/Aim: Misoprostol is frequently used as a single agent in pregnancy terminations. However, it increases the risk of uterine rupture in patients who have had previous uterine surgery and terminations due to stillbirths. Therefore, it is used with concern by clinicians. The aim of this study was to evaluate the clinical features of the groups that responded and did not respond to termination treatment with misoprostol in a tertiary center and to investigate its efficacy and safety. Methods: The study design was comprised of a retrospective cohort study. A total of 114 second trimester pregnancies (between 13-24 weeks gestational age) were included in the study. These pregnancies were indicated for termination based on the prenatal diagnosis unit for fetal or maternal causes. According to the International Federation of Gynecology and Obstetrics (FIGO) directions, misoprostol was applied in the following dosages: for 13-17 weeks gestational ages, one tablet per 6 hours; for 18-26 gestational ages, ½ tablet per 6 hours; and for other indications 2 tablets per 3 hours were administered. If the patient had had a previous cesarean operation, all doses were halved. After the first 24 hours, the percentage and demographics results, such as age, body mass index (BMI), gravida, number of cesareans, number of curettages, cervical lengths, BISHOP scores, gestational age, amniotic fluid index, and fetal cardiac beat of the patients with miscarriage, were recorded. Results: The number of cases resulting in miscarriage within 24 hours were 84 (73.7%) and within 48 hours were 14 (12.2%). The total of misoprostol doses used were 8 tablets of 200 mg, mean time until the complete abortion was 17 hours. Sixteen patients required additional treatment, of whom four required Foley catheterization, five required D&amp;E, seven required resting, and no one required a hysterectomy. Uterine rupture occurred in two patients who needed laparotomic surgery. The maternal age (P=0.340), BMI (P=0.790), gravida (P=0.270), previous cesarean history (P=0.390), previous curettage number (P=0.520), cervical length (P=0.380), Bishop score (P=0.190), gestational age (P=0.072), amniotic fluid index (P=0.470) and presence of fetal cardiac beat (P=0.350) were similar between groups Conclusion: Our results indicated that misoprostol is a safe, useful, and effective treatment option for second trimester medical terminations. Caution should be exercised in its use in patients with a history of uterine surgery.

Evaluation of Pain and Use of Analgesics during Medical Termination of Pregnancy in Real-Life Settings.

Women frequently report pain associated with medical termination of pregnancy (MToP), and its management can differ largely between centres. This study aimed at evaluating in real-life settings pain related to MToP and its management in France. This was a non-interventional prospective, longitudinal study run in 23 centres between 2015 and 2016 that included 893 pregnant women. Pain was reported by women prior any curative analgesic intake (CAI) through a five-level Likert scale (absence, mild, moderated, severe, extreme). Modalities of analgesic prophylaxis prescription (APP) and intake (API) and CAI were collected. Risk factors were investigated using ordinal logistic regression (for pain) or logistic regression (for CAI) with stepwise selection of variables. APP was prescribed to 657 (73.7%) women irrespective of the gestational age, among whom 386 (73.7%) took the treatment. Out of 740 women who documented their pain symptoms prior to any CAI, few declared no pain (n = 94, 12.7%) or intense pain (n = 88, 11.9%). The majority reported mild or moderate pain (n = 558, 75.4%). On multivariate analysis adjusted on gestational age, increasing initial [odds ratio (OR) 1.25, 95% confidence interval (CI) 1.06-1.47] or total dose (OR 1.15, 95% CI 1.05-1.26) of misoprostol taken were independent factors associated with risk of more pain. When adjusting for gestational age, initial dose of misoprostol (OR 1.69, 95% CI 1.45-2.66) and pain experienced (OR 3.58, 95% CI 2.82-4.55) were significantly associated with higher risk of CAI while API (OR 0.52, 95% CI 0.36; 0.75) was negatively associated. Most of the women received an APP, but not all used it. API and gestational age were not related to different risks of more pain following MToP, whereas history of at least one child showed a negative association. Higher doses of misoprostol were strongly associated with both pain and CAI. API was associated with a decreased risk of CAI.

A randomised comparative study of induction of labour with sublingual misoprostol 50 μg and oral misoprostol 50 μg in term patients

Background: Current study was conducted to compare the efficacy of tab Misoprostol 50 microgram by oral and sublingual routes for induction of labour. Methods: A randomised comparative study of induction of labour in 200 cases of pregnant women at term and were divided into two groups of 100 each for 50 µg Misoprostol for oral and sublingual route repeated 4 hourly either by sublingual or oral route until an adequate contraction pattern set in (establishment of 3 uterine contractions in a period of 10 minutes) or once the cervical dilatation reaches 4 cm, maximum up to 6 doses. The patients were monitored for maternal vital signs, progress of labour and foetal heart rate. Results: In this study, 86% women delivered vaginally with sublingual misoprostol while 76% were delivered vaginally with oral administration. In the present study, no significant maternal side effects were noted in either group. 4% cases of neonates in sublingual group and 6% cases of neonates in oral group required NICU admission. No still birth or neonatal deaths were seen. Conclusions: Our study shows that sublingual Misoprostol has better efficacy, shorter induction to delivery interval, requirement of fewer doses of misoprostol when compared to oral route.

In brief: Expanded acess to mifepristone.

First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies of up to 10 weeks' gestation. A single 200-mg oral dose of mifepristone followed 24-48 hours later by a single 800-mcg buccal dose of the prostaglandin analog misoprostol terminates early intrauterine pregnancies in about 95% of women.

Oral Misoprostol for Treatment of 1st Trimester Incomplete Abortion

Background: Abortion or miscarriage is a common health intervention. Incomplete abortion is a term given to miscarriage where there are retained product of conception still within uterus. Complications of incomplete abortion includes haemorrhage, infection, shock even DIC (Disseminated intravascular coagulation). Treatment of incomplete abortion has traditionally been surgery like D&amp;C or MVA. Though these treatments are effective but they require specialized equipment, trained person and associated with dangers like uterine trauma, perforation, bleeding to instrumentation, infection &amp; reaction to anaesthesia. For these reasons determining an effective nonsurgical approach for treatment of incomplete abortion is important. Materials &amp; Methodology: During the period of June 2021 to December 2022, 100 women diagnosed as incomplete abortion, were selected in Popular Diagnostic Centre (Badda, Dhaka) and in US-Bangla Medical College Hospital (Narayanganj) as per inclusion criteria and treated with Tablet Misoprostol 6ooµg orally and success to treatment was noted. Results: Treatment was found successful in 94% cases. 6% Cases needed MVA. Among 94% cases 32% was successful after 1st dose of Misoprostol and 62% was after 2nd dose of Misoprostol. Conclusions: Oral Misoprostol is very effective method with high patient satisfaction.

Mifepristone priming and subsequent misoprostol for second trimester medical abortion in women with previous caesarean delivery.

To assess clinical outcomes and complications in women with ≥1 prior caesarean delivery (CS) during mid-pregnancy medical abortion with misoprostol following mifepristone priming. Retrospective analysis of abortions at 13-28 weeks gestation using sequential mifepristone and misoprostol at a single centre from 1/2008-12/2018. Procedural outcomes were compared between cases with no prior CS, one prior and ≥2 prior CS. There were 1399 consecutive women who underwent a medical abortion, with 304 (21.7%) having ≥1 prior lower segment CS (241 one, 49 two, 12 three, one four) and one a prior classical CS. Median gestation was 19 weeks (interquartile range (IQR) 17-21) among nulliparas, multiparas with no prior CS and multiparas with prior CS, P= 0.505. Compared with nulliparas (median procedural duration 10.8 h, IQR 7.5-16.5; adjusted hazards ratio (aHR)=1.20 95%CI 1.04-1.40, P= 0.015), multiparas with prior CS had a shorter procedural duration (9.5 h, IQR 6.5-13.5) while multiparas with no CS had the shortest duration (7.0 h, IQR 5.0-9.8; aHR=2.28 95%CI 2.01-2.58, P< 0.001). Complications were more frequent with prior CS: estimated blood loss (medians: 100 cc no CS vs 150 cc ≥1 CS, P= 0.002), blood loss >1000 cc (3.6% no CS vs 7.2% ≥1 CS; odds ratio (OR)=2.11 95%CI 1.23-3.62, P= 0.007) and placental retention (17.3% no CS vs 25.3% ≥1 CS; adjusted OR=1.44 95%CI 1.05-1.99, P= 0.024). Uterine rupture occurred in 4/304 women with ≥1 prior CS (1.3%). Mifepristone-misoprostol abortion in women with prior CS is generally safe but associated with an increased risk of procedural complications. Lowering of the misoprostol dosage with prior CS may reduce uterine rupture, although this hypothesis requires ongoing research.

Potentially acute misoprostol toxicity during third-trimester pregnancy: a case report

Background: The International Federation of Gynecology and Obstetrics (FIGO) recommends the dosage of misoprostol for pregnancy termination in &gt;28 weeks is 25 mcg to 100 mcg per-vaginal or sublingual or buccal, every 6 hours, and the maximum dose is 6 mg. Acute misoprostol toxicity is rarely reported, including in the case of pregnant women. This study aims to discuss the effect of potentially acute misoprostol toxicity in pregnant women and the fetus. Case Presentation: A 17 years-old woman, G1, 32 weeks, presented with singleton intrauterine fetal death. The patient previously consumed 14 tabs of oral misoprostol and 4 tabs of misoprostol intravaginally. Her vital signs were within a normal level, his 4x/10'/40", and her fetal heart rhythm was negative. From vaginal touché found complete dilation. The patient led to bear down and born baby boy, demise fetal, 1965-gram, 43 cm, no maceration and placenta born completely. After delivery, the mother was in good condition. Misoprostol is a synthetic analog of prostaglandin E1, which can be used for uterotonics and cervical ripening. In pregnant women, misoprostol toxicity can induce hypertonic uterine contractions, leading to fetal distress and death, rhabdomyolysis, hyperthermia, respiratory alkalosis, hypoxemia, and metabolic acidosis. One article reported maternal death due to upper gastrointestinal bleeding and multiorgan failure. We analyze that intrauterine fetal death may happen because of excessive misoprostol that induces hypertonic uterine contraction, causing fetal distress and leading to fetal demise. Conclusion: Excessive consumption of misoprostol or potentially acute misoprostol during the third-semester pregnancy can lead to harmful effects for both mother and fetus.

Importance of Intermittent Cardiotocographic Monitoring Prior to Misoprostol-Assisted Induction of Labour

Aim: To determine the importance of intermittent cardiotocographic monitoring during misoprostol-assisted induction of labour in pregnancies lasting weeks or more. Methods: This descriptive study was carried out in the Obstetrics and Gynecology department of Combined Military Hospital, Kharian Cantt for the duration from January 2022 to August 2022 among 130 primigravida patients underwent CTG before receiving transvaginal dose of misoprostol. Neonatal admissions, the mode of delivery, the Apgar score, and indications of induction were the variables examined. Results: Forty-two (70%) of the C-section patients had reassuring CTG and significantly low Apgar scores at 1 minute. Seven (8.5%) of the patients with thick meconium had non-reassuring CTG. Twelve neonates (9.2%) in total required resuscitation, 9 (75%) of whom had reassuring CTGs while 3(25%) had non-reassuring CTGs. The overall admission rate in NICU was 10%, and 38.5% of neonates that required resuscitation had non-reassuring CTG. Neonatal mortality was nil during the study time. Conclusions: Patients who had their labour induced with misoprostol had non-reassuring CTG among 50% of cases and had thick meconium stained liquor. Therefore, we can lower neonatal morbidity and mortality by early foetal impairment detection. Neonatal mortality was nil during the study time. Keywords: cardiotocography, induction, resuscitation, Apgar score and caesarean section

Mifepristone-misoprostol combination treatment for early pregnancy loss after embryo transfer: a case series

Evidence strongly supports the use of mifepristone-misoprostol combination treatment for early pregnancy loss (EPL) among pregnancies conceived without assisted reproductive technologies. No literature exists, however, regarding the efficacy of this treatment in the medical management of EPL among pregnancies after invitro fertilization and embryo transfer (IVF-ET). These patients differ as some use exogenous hormonal supplementation to provide pregnancy support. Thus, the management for EPL may differ between unassisted conceptions and those after ET. Mifepristone, a progesterone receptor antagonist, may demonstrate an altered treatment effect when used with misoprostol to manage EPL in assisted reproductive technologie-conceived pregnancies. To describe our institution's experience using mifepristone-misoprostol to manage EPL after invitro fertilization with embryo transfer IVF-ET. Retrospective case series. Single academic institution from 2020 to2022. Nine patients with ultrasound confirmed EPL after IVF-ET. All 9 patients underwent invitro fertilization followed by fresh or frozen embryo transfer. All 9 received 200 mg of mifepristone 24 hours before 800 μg of misoprostol. Incomplete abortion, need for surgical management, number of days to negative serum human chorionic gonadotropin (hCG). Of the 9 subjects included, one had a programmed frozen embryo transfer cycle, 6 had modified natural frozen embryo transfer cycles, and 2 underwent fresh ET. Eight subjects had successful expulsion of tissue with one dose of treatment, and one required uterine aspiration. No subjects required additional dosing of misoprostol. The mean number of days elapsed from mifepristone treatment to tissue expulsion was 4.89 ± 11.30 days and the mean days to negative-range serum hCG was 36.89 ± 18.59 days. At the initial ultrasound, all pregnancies had one gestational sac seen; 5/9 had a yolk sac; only 3 had fetal cardiac activity. The mean gestational age at the time of EPL diagnosis was 55.22 ± 8.77 days, with the majority (8/9) having completed 7 weeks gestation. Mifepristone-misoprostol combination treatment appears to be a reasonable option for those with EPL after IVF-ET. Future, larger-scale studies are needed comparing combination treatment with misoprostol only among various ET protocols.

Preoperative misoprostol in reducing blood loss during myomectomy

Background and aim Uterine myomata are by far the most common benign tumors in women of fertility age. Myomectomy can be used to treat manifested uterine myomas while maintaining the ability to become pregnant. The most serious operative risk is uncontrolled intraoperative bleeding with life-threatening complications, making the procedure more dangerous than hysterectomy and necessitating the services of an experienced surgeon. Several ways are being applied to alleviate this complication. The study aim was to evaluate the role of sublingual misoprostol (prostaglandin E1, 400 μg) administered 60 min preoperatively for reducing blood loss during abdominal myomectomy. Patients and methods This randomized prospective controlled study was applied on 40 women with manifested uterine myomas, who were subsumed for myomectomy. Among women subsumed for abdominal myomectomy surgery, 60 min before the surgery women in the study group (n=20) were administered a single dose of sublingual misoprostol (400 μg) while those in the control group (n=20) were administered placebo. Results Postoperative blood loss, postoperative hemoglobin, and hospitalization time mean (252.5±170.5 ml, 10.8±1.02 g/dl, and 1.8±0.4 day, respectively) were significantly reduced (P=0.003, 0.032, and 0.004, respectively) in patients given preoperative sublingual misoprostol, and so there were consequently higher postoperative values of hemoglobin in these patients. As regards the operation time, intraoperative blood loss, and blood transfusion there was a decreased need in the study group but not statistically significant P-value (0.065, 0.077, and 0.311, respectively). Conclusions A single preoperative dose of sublingual misoprostol may be a simple, easily applicable, and cozy method for reducing intraoperative blood loss during abdominal myomectomy.

Corticosteroids and Duration of Medical Induction for Mid-Trimester Abortion

Background: Abortion is defined as the termination of pregnancy (TOP) before fetal viability, regardless of the method used. It has been shown that using misoprostol alone to medically end an abortion in the second trimester is successful. Aim and objectives: The purpose of the research was to assess the impact of intramuscular dexamethasone on the length of induced second trimester abortion in pregnant women between the ages of 16 and 24 weeks of gestation. Patient and methods: From January 2020 to May 2021, this research was conducted in the Obstetrics and Gynecology Department of Qena General Hospital and Qus Central Hospital. A total of 200 pregnant women consented to participate in this research and they were selected from the emergency wards. All women considered for this study were in the second trimester at gestational age from 16 to 24weeks, who were planned for medical induction of abortion. These inclusion and exclusion criteria were used to recruit women. Result: most of cases (94.5%) and (98%) at two groups respectively were Satisfied, there was statistical substantial variation between groups as regard to satisfaction. Conclusion: the administration of dexamethasone intra- muscularly (12 mg every 24h) with the medical induction of abortion by misoprostol (200 mcg intra vaginally every 4hr) appears to be effective as regard shortening the induction-abortion interval (duration between the initiation of induction and expulsion of fetus), reducing the overall misoprostol dosage and the duration of the hospitalization. Its cost effective and availability are apparent benefits

What is the most effective dose and route of misoprostol for labor induction?

What is the most effective dose and route of misoprostol for labor induction?

The effect of multiple doses of misoprostol for missed abortion treatment on subsequent pregnancy outcome

Prostaglandin E1 (PgE1) treatment, known as Misoprostol, is used for 1st trimester missed abortion (MA) treatment, in a single dose or more when products of conception are not entirely expelled. However, an association between the use for multiple doses of Misoprostol and the occurrence of retained products of conception (RPOC) in the subsequent pregnancy, along with other adverse maternal outcome has not yet been evaluated. Our objective was to evaluate the effects of repeated Misoprostol doses on subsequent live pregnancy outcome, especially RPOC.

Effectiveness and safety of vaginal versus sublingual misoprostol for cervical ripening and induction of labor: A randomized controlled trial

Background: Vaginal misoprostol is a highly effective method of cervical ripening and induction of labor; however, it is associated with some complications. Therefore, there is need to explore other routes of administration that may be safer, acceptable, and also effective. Objective: The aim of this study was to compare the effectiveness and safety of vaginal versus sublingual misoprostol for cervical ripening and induction of labor. Materials and Methods: This was a randomized controlled trial conducted among booked antenatal women in Owerri, South-East Nigeria. The eligible participants were randomized to receive either 25 μg of misoprostol vaginally (n = 90) or 25 μg sublingually (n = 90). Outcome measures included delivery within 24 h, induction to delivery interval, cesarean section rate, side effects of misoprostol, Apgar Score at birth, and admission into the Neonatal Intensive Care Unit. Results: There was no significant difference in the effectiveness and side effects of both routes of administration (p > 0.05). The results were comparable in both groups, except for the time to reach the active phase of labor (vaginal route 16.64 ± 9.12 vs. sublingual route 13.78 ± 7.47, P = 0.023) and the number of doses of misoprostol used (vaginal route 2.81 ± 1.53 vs. sublingual route 2.34 ± 1.49, P = 0.040). Conclusion: The effectiveness of cervical ripening and induction of labor is comparable in both groups and the side effect profile is also similar. Hence, the sublingual route is as effective and as safe as the vaginal route but with added advantage of shortening the duration of active phase of labor and requiring less doses for induction of labor.

A randomized controlled trial comparing combined medical and mechanical method for early mid-trimester abortion (13-20 weeks).

To examine the combined effect of a medical and mechanical method on induction-to-abortion interval (IAI) in women undergoing early mid-trimester abortion (MTA) (13-20 weeks of pregnancy). A randomized controlled trial was conducted among women undergoing MTA. Primary outcome was IAI. At enrollment, 60 women were randomized (group 1: medical method alone [mifepristone 200 mg, then 48 h later vaginal misoprostol 400 μg every 4h] versus group 2: combined medical and mechanical method [transcervical Foley catheter inflated with 60 ml of normal saline]). Demographic and clinical data were collected at enrollment and abortion. Women in group 2 had statistically significantly shorter IAI (mean ± standard deviation: 347 ± 130 min vs. 640 ± 242 min, for group 2 and group 1, respectively; P< 0.001). All the women in group 2 had complete abortion within 12 h, compared with 19 (63%) in group 1 (P< 0.001). Median number of doses of vaginal misoprostol (400 μg every 4h) required in group 1 was 4 (interquartile range [IQR] 3-5) versus 1 (IQR 1-3) in group 2 (P< 0.001). Statistically significantly fewer women required additional oxytocin (group 1 vs. group 2; 4 vs. zero, respectively, P= 0.038). All women in the study had complete abortion. There was no significant difference with respect to maternal complications. A combined medical and mechanical method significantly shortens the IAI (P< 0.001) in women undergoing early MTA (13-20 weeks of pregnancy). Clinical Trial Registry of India www.ctri.nic.in CTRI/2020/12/030077 (date; 28-12-2020).

Single dose letrozole and misoprostol for termination of pregnancy through 63 days’ gestation: A pilot study

ObjectivesWe conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion Study designWe 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 ResultsThirty-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 ConclusionA single dose of letrozole 30 mg followed by misoprostol had lower than desirable efficacy and does not warrant further study. ImplicationsA single dose of letrozole does not appear to be an effective adjunct to misoprostol for medication abortion.

Cervical change times during induction in nulliparas using vaginal or buccal misoprostol

Aim To determine if the time to cervical change and time to active labor were different when misoprostol was administered by a vaginal or buccal route for cervical ripening in nulliparas undergoing labor induction at term. Methods This was a secondary analysis of nulliparous participants in the IMPROVE Study—A comparison of vaginal versus buccal misoprostol for cervical ripening for labor induction at term: a triple-masked randomized controlled trial (NCT 02408315). The parent study was a non-inferiority randomized controlled trial in which patients beginning induction with a modified Bishop score ≤6 received either vaginal or buccal misoprostol and simultaneous placebo via the opposite route. The primary outcome of the parent study was time to delivery. Primary outcomes for this secondary analysis were the time to active labor (at least 6 cm dilated) and time to change in cervical dilation. Kaplan–Meier analysis was used to compare routes for time to active labor and multistate Markov modeling was used to compare sojourn times at each cervical dilation. Results Of the 300 participants enrolled in the parent trial, 124 (41.3%) were nulliparous; 59 (47.6%) nulliparous participants underwent induction with vaginal misoprostol and 65 (52.4%) received buccal dosing. Nulliparas receiving vaginal dosing required fewer doses of misoprostol to reach active labor (median 2 vs 3, p = .003). However, this did not result in shorter time to active labor (median vaginal 23.1 h, 95% CI = [21.6, 27.2 h]; buccal 25.6 h [21.5, 29.3 h], p = .45) or higher rate of vaginal delivery within 24 h; (33.9% vs 35.4%, p = .86). There was also no significant difference in time to active labor after adjusting for covariates (adjusted HR for dose route (buccal vs vaginal) = 0.91 [0.61, 1.36], p = .649). Among people that delivered vaginally, the mean sojourn times, measuring cervical dilation state change, were not significantly different, with mean duration to active labor of 20.5 [17.6, 24.5] h for buccal and 21.8 [17.7, 28.2] h for vaginal dosing (p = .092). Satisfaction and preference for dosing routes were not different between groups. Conclusion Buccal and vaginal dosing of misoprostol for cervical ripening in nulliparas appear to have similar times to active labor and progression of cervical change during ripening.