Pregnancy Outcomes After Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT0210094.

Intrauterine adhesion in ultrasound-guided manual vacuum aspiration (USG-MVA) versus electric vacuum aspiration (EVA): a randomised controlled trial.

BACKGROUND: Intrauterine adhesion (IUA) can arise as a potential complication following uterine surgery, as the surgical procedure may damage the endometrial stratum basalis. The objective of this study was to assess and compare the occurrence of IUA in women who underwent ultrasound-guided manual vacuum aspiration (USG-MVA) versus electric vacuum aspiration (EVA) for managing first-trimester miscarriage. METHODS: This was a prospective, single-centre, randomised controlled trial conducted at a university-affiliated tertiary hospital. Chinese women aged 18 years and above who had a delayed or incomplete miscarriage of ≤ 12 weeks of gestation were recruited in the Department of Obstetrics and Gynaecology at the Prince of Wales. Recruited participants received either USG-MVA or EVA for the management of their miscarriage and were invited for a hysteroscopic assessment to evaluate the incidence of IUA between 6 and 20 weeks after the surgery. Patients were contacted by phone at 6 months to assess their menstrual and reproductive outcomes. RESULTS: 303 patients underwent USG-MVA or EVA, of whom 152 were randomised to 'USG-MVA' and 151 patients to the 'EVA' group. Out of the USG-MVA group, 126 patients returned and completed the hysteroscopic assessment, while in the EVA group, 125 patients did the same. The incidence of intrauterine adhesion (IUA) was 19.0% (24/126) in the USG-MVA group and 32.0% (40/125) in the EVA group, showing a significant difference (p < 0.02) between the two groups. No significant difference in the menstrual outcomes at 6 months postoperatively between the two groups but more patients had miscarriages in the EVA group with IUA. CONCLUSIONS: IUAs are a possible complication of USG-MVA. However, USG-MVA is associated with a lower incidence of IUA postoperatively at 6-20 weeks. USG-MVA is a feasible, effective, and safe alternative surgical treatment with less IUA for the management of first-trimester miscarriage. TRIAL REGISTRATION: The study was registered with the Centre for Clinical Research and Biostatics- Clinical Trials Registry (CCRBCTR), which is a partner registry of the WHO Primary Registry-Chinese Clinical Trials Registry (ChiCTR) (Unique Trial Number: ChiCTR1900023198 with the first trial registration date on 16/05/2019).

Incidence of intrauterine adhesion after ultrasound-guided manual vacuum aspiration (USG-MVA) for first-trimester miscarriages: a prospective cohort study.

PURPOSE: Ultrasound-guided manual vacuum aspiration (USG-MVA) is a feasible and effective outpatient treatment to treat early pregnancy loss. METHODS: This was a prospective observational study at a university-affiliated hospital. All women undergoing either a USG-MVA or electric vacuum aspiration (EVA) were invited to return 3-6 months later for follow-up at which women completed a questionnaire to document their post-evacuation menstrual and reproductive history, and underwent a hysteroscopy if they were not pregnant. The severity of intrauterine adhesion (IUA), if present, was graded (Stage I-III) according to the American fertility society classification. RESULTS: A total of 292 women had a hysteroscopy after their initial surgical evacuation, USG-MVA 169(57.9%) versus EVA 123(42.1%). Women undergoing EVA as opposed to a USG-MVA had a 12.9% higher incidence of IUA (24.1% vs. 37.0%, p = 0.042) equivalent to 1.84 times higher risk (95% CI 1.01-3.34; p = 0.048). Women having EVA continued to show an increased but not statistically significant trend towards an increased risk of IUA after adjusting for the type of miscarriage (aOR = 1.3; 95% CI 0.66-2.50; p = 0.46). CONCLUSION: There were no significant differences in their reproductive outcomes and fewer women post-USG-MVA complained of hypomenorrhea. IUA may still occur in women undergoing USG-MVA but it is lower than the rate in women undergoing EVA. Clinical trials registry The trial was registered with the Centre for Clinical Research and Biostatistics - Clinical Trials Registry (CCRBCTR), a partner registry of the WHO Primary Registry-Chinese Clinical Trials Registry (ChiCTR) with a Unique Trial Number: CUHK_CCRB00541 on 22 Dec 2016.

[Impact of Endometriosis on the Therapeutic Effect of Hysteroscopic Fallopian Tube Catheterization Combined With Laparoscopy in Infertile Patients With Proximal Tubal Obstruction].

Objective: To investigate the impact of endometriosis on the therapeutic effect of hysteroscopic fallopian tube catheterization combined with laparoscopy in infertile patients with proximal tubal obstruction. Methods: We conducted a retrospective analysis of patients who underwent hysteroscopic fallopian tube catheterization combined with laparoscopy for infertility caused by proximal fallopian tube obstruction between January 19, 2016 and March 20, 2020 at the Department of Reproductive Endocrinology, West China Second Hospital, Sichuan University. During the operation, hydrotubation was performed to verify whether there was proximal tubal obstruction. Then, the patients were categorized into an endometriosis group and a non-endometriosis group according to whether their proximal tubal obstruction was combined with endometriosis. The baseline data were balanced by propensity score matching and the rate of successful surgical unblocking of proximal tubal obstruction in infertile patients by hysteroscopic fallopian tube catheterization combined with laparoscopy was calculated. Treating cases lost to follow-up in both groups as non-pregnant cases according to the principle of intention-to-treat analysis, we followed up the pregnancy outcomes after surgery. The primary indicators included overall successful surgical unblocking rate, clinical pregnancy rate, and spontaneous pregnancy rate, while the secondary indicators included live birth rate, miscarriage rate, ectopic pregnancy rate, and the mean time to spontaneous pregnancy after surgery. The primary indicators included overall successful surgical unblocking rate, clinical pregnancy rate, and spontaneous conception rate, while the secondary indicators included live birth rate, miscarriage rate, ectopic pregnancy rate, and the mean time to spontaneous pregnancy after surgery. Results: After propensity score matching, 113 cases were included in each of the two groups, with the overall successful surgical unblocking rate being 72.6%. The successful surgical unblocking rate of patients in the endometriosis group was higher than that of the non-endometriosis group, with the difference being statistically significant (78.8% vs. 66.4%, P<0.05). A total of 38 patients were lost after follow-up matching. Postoperative follow-up was performed to date and, through intention-to-treat analysis, the spontaneous conception rate was found to be higher in the endometriosis group than that in the non-endometriosis group (44.2% vs. 30.1%, P<0.05), while the mean time to spontaneous pregnancy after surgery was shorter in the endometriosis group than that in the non-endometriosis group (46 months vs. 53 months, P<0.05). There was no significant difference in clinical pregnancy rate, live birth rate, miscarriage rate, and ectopic pregnancy rate between the endometriosis group and the non-endometriosis group ( P>0.05). Conclusion: When infertility caused by proximal tubal obstruction is combined with endometriosis, performing hysteroscopic fallopian tube catheterization combined with laparoscopy contributes to the improvement of reproduction outcomes.

The comparative analysis of laparoscopic or transvaginal cerclage in pregnancies with cervical insufficiency: a retrospective cohort study.

OBJECTIVE: To evaluate the efficacy and safety of prophylactic cervical cerclage by laparoscopy in pregnant women versus transvaginal way. DESIGN: Retrospective, monocentric cohort study was performed. SETTING: The First Affiliated Hospital of Sun Yat-sen University. PATIENTS: Cases with cervical insufficiency (defined by previous history of painless second or early third trimester pregnancy loss/losses) were selected. INTERVENTIONS: Laparoscopic or transvaginal cerclage were conducted. The maternal information and the neonatal data were collected and compared. The pregnancy outcomes including the incidence of full-term labor and gestational weeks at delivery were defined as the primary outcomes. Neonatal survival and birth weight, neonatal complications were evaluated as the secondary outcomes. MEASUREMENTS AND MAIN RESULTS: Totally 36 twin pregnant cases and 82 singleton pregnant cases were managed with cerclage, either trans-laparoscopy (totally 78 cases) or transvaginal (totally 40 cases). Demographic characteristics showed no significant differences. Cases in laparoscopic group had a prolonged gestational age at delivery (36.43 ± 0.93 weeks and 33.60 ± 2.78 weeks, respectively, P < 0.001), a higher incidence of full-term labor (60.26% vs 42.50%, P = 0.05) with no significant difference of perinatal mortality (P = 0.661). Meanwhile, higher incidence of normal birth weight infants (88.46% vs 67.50%, P = 0.007) was shown in laparoscopic group with no more complications such as the cases of neonatal with Apgar < 7 (P = 0.296), and the incidence of NICU admission (P = 0.237). Besides, LTC showed good efficiency on VTC in the incidence of full-term labor: HR 0.24 (95% CI 0.070-0.85), P < 0.001. While LSC showed the similar efficiency on VSC: HR 0.734 (95% CI 0.36-1.49), P = 0.857, showing that cases with twin pregnancy may benefit more from laparoscopic cerclage. CONCLUSIONS: The comparative effect between laparoscopic and transvaginal cerclage in pregnant women showed that laparoscopic cerclage may be a relatively effective and safety prophylactic way for cervical insufficiency. This would be an acceptable and safe replace for traditional transvaginal cervical cerclage.

Hystero-embryoscopy: evaluation and evacuation of spontaneous missed abortions.

OBJECTIVE: To demonstrate the steps for hystero-embryoscopic evaluation of a 7-week spontaneous missed abortion and evacuation of the products of conception. Illustrate the surgical technique and highlight its advantages in improving the evaluation of spontaneous missed abortions. DESIGN: Video case presentation and demonstration of surgical technique. SETTING: Tertiary referral center. PATIENT(S): The patient provided consent for the video and its publication. INTERVENTION(S): Following vaginoscopy, the cervix was approached without prior blind cervical dilation. Navigation from the endocervix to the endometrial cavity was performed using a 2.9-mm diameter hysteroscope. The endometrial cavity was thoroughly inspected revealing an intact gestational sac and submucosal fibroids. An operative grasper was introduced, the chorion and amnion were penetrated, and embryoscopy was performed. In-flow was reduced for external morphological inspection of the embryo, which was then grasped and retrieved. The procedure was continued by introducing of a 26-french bipolar resectoscope, after which the products of conception were excised without electricity and sent for histologic and genetic analyses. MAIN OUTCOME MEASURE(S): This procedure allowed for proper embryonic evaluation and hysteroscopic evacuation of products of conception was successfully performed. RESULT(S): Cytogenic analysis of this case revealed a female embryo with trisomy 15. No maternal and fetal cell admixture was noted in the analysis, allowing a precise diagnosis. CONCLUSION(S): Hystero-embryoscopy is a valuable diagnostic and therapeutic procedure for cases of missed abortion. It may reveal embryonic morphological abnormalities, expand the diagnostic spectrum in the evaluation of pregnancy loss, and avoid potential complications from blind curettage.

Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study).

BACKGROUND: Miscarriage is a frequent problem that requires dilation and curettage in 30% of cases. This routine surgery may lead to intrauterine adhesions and severe infertility. Hyaluronic acid gel is known to reduce intrauterine adhesions after hysteroscopic surgery. OBJECTIVE: This study aimed to evaluate the rate of intrauterine adhesions after dilation and curettage for miscarriage with and without hyaluronic acid gel. STUDY DESIGN: This was a multicentric (9 hospitals in France), prospective, open-label randomized trial. Patients who had a miscarriage between weeks 7 and 14 of gestation, required dilation and curettage, and wanted another pregnancy were eligible for the study. Women were randomly assigned in a 1:1 ratio to surgery alone (control group) or surgery with intrauterine instillation of hyaluronic acid gel (gel group). An office hysteroscopy was planned at 6 to 8 weeks after surgery. The primary endpoint was the rate of intrauterine adhesions during this office follow-up hysteroscopy. Two different follow-up fertility surveys were sent at 6 months and 1 year after the end of the intervention, respectively. RESULTS: Among the 343 patients who had curettage, 278 had hysteroscopy. After multiple imputation, the rate of intrauterine adhesions was lower in the gel group than in the control group (9.1% vs 18.4%, respectively; P=.0171). Among the 110 responders to the surveys, the overall pregnancy rate at 12 months after surgery was 64.5% (71/110), and similar in both groups (57.4% [27/47] in the control group vs 69.8% [44/63] in the gel group; P=.1789). CONCLUSION: Intrauterine instillation of hyaluronic acid gel reduces the rate of intrauterine adhesions in women treated with dilation and curettage for miscarriage.

Survey on spontaneous miscarriage and induced abortion surgery safety at less than 12 weeks of gestation in Japan.

AIM: In Japan, dilatation and curettage (D&C) is a common procedure for spontaneous miscarriage and induced abortion, and its safety has long been an issue. Electric vacuum aspiration (EVA) is also common, but manual vacuum aspiration (MVA) was introduced recently, with medical abortions using mifepristone or misoprostol which are not yet legally accepted. This nationwide retrospective study surveyed the surgical methods and complications associated with spontaneous miscarriage and induced abortion at less than 12 weeks of gestation in Japan to assess their safety, in comparison with a similar survey for induced abortions in 2012. METHODS: Questionnaires were sent to 4176 facilities with a license for induced abortion surgeries in 2019. The questions included were the methods used, number of spontaneous miscarriages and induced abortions, and number of complications (uterine perforation, incomplete abortion, and gross bleeding requiring blood transfusion). RESULTS: Responses were received from 1706 facilities (40.9%). Although EVA with sharp curettage was the most common surgical method, which was used for 11 953 spontaneous miscarriages (28.9%) and 24 045 induced abortions (37.3%), the most common surgical method per facility was D&C, and the rates of D&C for spontaneous miscarriages (38.4%) and induced abortions (44.7%) performed in general hospitals were significantly higher than those in clinics (24.1% and 22.0%, respectively). There was no significant difference in the complication incidence rate among surgical methods for spontaneous miscarriages. However, in induced abortion surgery, the total complication and incomplete abortion incidence rates for D&C were significantly higher than those for EVA without sharp curettage (47/15 162 [0.31%] vs. 29/18 693 [0.16%], p = 0.00362, 45/15 162 [0.30%] vs. 27/18 693 [0.14%], p = 0.00285, respectively). There was no significant difference in the complication incidence rate between MVA and other surgical methods for each abortion surgery. CONCLUSION: In Japan, especially in general hospitals, D&C is still widely used for miscarriage and induced abortion surgery. Its complication-incidence rates significantly decreased compared with that of the nationwide survey in 2012, but were still significantly higher than EVA without sharp curettage. Few facilities used MVA, but its complication rate was comparable with those of other surgical methods.

A Pilot Study of Guided Conservative Hysteroscopic Evacuation of Early Miscarriage.

STUDY OBJECTIVE: To evaluate initial feasibility and experience with guided hysteroscopic morcellation for uterine evacuation of early miscarriage. DESIGN: A prospective pilot study of 10 cases. SETTING: A tertiary university hospital in Israel. PATIENTS: Women with confirmed early miscarriage at a gestational age of below 10 weeks from the last menstrual period. INTERVENTIONS: From May 2020 to October 2020, the hysteroscopic TruClear tissue removal system (Medtronic, Minneapolis, MN) was used for evacuation of early miscarriage in 10 women. The procedures were recorded. MEASUREMENTS AND MAIN RESULTS: Data including the length of the procedure, visibility, complete evacuation, bleeding, complications, and follow-up ultrasonography (US) were recorded. The mean duration of the procedure was 24 minutes. Complete evacuation was recorded in all cases. No adverse events were recorded in any of the 10 procedures. Normal uterine cavity without evidence of retained products of conception was documented in follow-up evaluation by US in all cases. Four patients underwent a follow-up office hysteroscopy that demonstrated a normal cavity without evidence of adhesions. In 4 cases (40%), an additional suction curettage was performed immediately after the hysteroscopic procedure owing to obscured visibility or an abnormal US scan at the end of the procedure. However, retained products of conception were found in only 1 of these 4 suction specimens (25%). CONCLUSION: Hysteroscopic morcellation under vision seems to be a safe and feasible technique for management of early missed abortion. This method may have potential as an innovative treatment of miscarriage in selected cases. Further studies are needed to refine the indications and the surgical technique.

Safety and efficacy of manual vacuum suction compared with conventional dilatation and sharp curettage and electric vacuum aspiration in surgical treatment of miscarriage: a randomized controlled trial.

BACKGROUND: The World Health Organization does not recommend dilatation and sharp curettage (D&C) for the surgical treatment of miscarriage during the first trimester because this may cause Asherman's syndrome due to endometrial damage; therefore, suction remains the primary treatment option. While manual vacuum aspiration (MVA) has been widely used since the 1990s outside Japan, the use of an MVA device (Women's MVA system) was approved in Japan in October 2015. Here, we examined the efficacy of the MVA kit in women surgically treated for miscarriage. METHODS: This retrospective cohort study was conducted between 2014 and 2018 at the International University of Health and Welfare Hospital in Japan. Women who underwent surgical treatment for miscarriage within 12 weeks of pregnancy were identified and enrolled in the study. A total of 404 women were included who underwent the following procedures: 121 D&C, 123 electric vacuum aspiration (EVA), and 160 MVA. For each participant, the duration of surgery, amount of bleeding, amount of anesthetic used, incomplete abortion requiring repeat procedures, and intraoperative/postoperative complications were evaluated. RESULTS: The duration of surgery was 13.7 ± 7.2, 11.2 ± 4.2, and 6.9 ± 4.3 min in the D&C, EVA, and MVA groups, respectively (p = 1.00). The amount of anesthetic used was not significantly different among all groups. Bleeding of ≥ 100 mL was confirmed in three (2.4%), one (0.8%), and one (0.6%) patient(s) in the D&C, EVA, and MVA groups, respectively (p = 0.50). Incomplete abortion was identified in three (2.4%), two (1.6%), and one (0.6%) patient(s) in the D&C, EVA, and MVA groups, respectively (p = 0.61). However, severe intraoperative/postoperative complications were not observed in any group. CONCLUSIONS: Surgical treatment for miscarriage performed using the MVA kit has safety and efficacy similar to those of conventional methods, such as D&C and EVA.

A four step strategy for robot assisted abdominal cerclage placement prior to pregnancy.

OBJECTIVE: To demonstrate a simple, stepwise strategy for robot-assisted abdominal cerclage placement before pregnancy. DESIGN: Demonstrative video presentation. Surgical footage surrounding a case report is used to describe a four-step technique for robot-assisted abdominal cerclage placement in women with recurrent pregnancy loss or other anatomic variants before pregnancy. This video article was reviewed by the Investigational Review Board and further investigation was waived because the study was "not considered human subject research." SETTING: Tertiary medical center. PATIENT(S): A 38-year-old G4P0220 (Gestations: 4, Term deliveries: 0, Preterm deliveries: 2, Abortions: 2, Living children: 0) with a history of two second trimester losses who had failed a prior history-indicated transvaginal cerclage (Fig. 1). INTERVENTION(S): The patient underwent an uncomplicated robot-assisted abdominal cerclage using a four-step strategy: Step 1, create the bladder flap; Step 2, identify pertinent anatomy; Step 3, place the cerclage; and Step 4, hysteroscopy. MAIN OUTCOME MEASURE(S): Intraoperative technique presenting a four-step method to ensure successful robot-assisted abdominal cerclage placement. RESULT(S): Robot-assisted abdominal cerclage is a safe, viable alternative to traditional abdominal cerclage placed via laparotomy. This video outlines four critical steps to facilitate placement and decrease patient morbidity. This patient did well operatively without increased blood loss or operative time and was discharged home on postoperative day 1. She went on to have a successful future pregnancy and currently is scheduled for an elective cesarean section at term. CONCLUSION(S): Abdominal cerclages significantly improve pregnancy and neonatal outcomes in women who previously have failed transvaginal cerclage. Robot-assisted abdominal cerclage placement allows a minimally invasive approach with enhanced dexterity and better visualization for the surgeon compared with conventional laparoscopy or laparotomy, as well as decreased pain and shorter recovery time for patients. This video demonstrates placement of a robot-assisted abdominal cerclage in a patient with recurrent pregnancy loss using a simple four-step strategy to ensure successful, correct, and easy placement. To our knowledge, this is the first video demonstrating a stepwise approach to robot-assisted abdominal cerclage placement.

Experiencia clínica del uso de la ficha SIP/CLAP en mujeres con aborto espontáneo resuelto por vía quirúrgica / Clinical experience of the use of the SIP/CLAP form use in women with spontaneous abortion treated by surgical means

INTRODUCCIÓN Y OBJETIVOS: En Chile, existen datos parcializados en cuanto a la prevalencia de aborto. La población migrante ha generado un cambio en las características de las pacientes en situación de aborto. El objetivo es describir las características demográficas y clínicas de las mujeres con aborto de manejo quirúrgico con y sin complicaciones. MÉTODOS: Estudio Descriptivo Transversal. Se incluyeron mujeres atendidas por aborto, sometidas a método de evacuación y que estuvieran ingresadas al sistema SIP/CLAP. Se compararon mujeres con o sin complicaciones con respecto a diferentes características demográficas y clínicas. Se calculó Odd Ratio para algunas variables de interés. RESULTADOS: Se incluyeron 554 mujeres, un 13% (N= 73) tuvo complicación al ingreso, principalmente hemorrágica (40%). Las características demográficas fueron similares en ambos grupos. Hubo mayor riesgo de complicación en mujeres con abortos previos (OR: 2,4 (IC 1,3-4,5), p =0.00), cuando el diagnóstico de ingreso fue aborto incompleto (OR: 85,3 (IC 25,2-288), p=0,00) y cuando se realizó legrado (OR: 4 (IC 2,5-6,5) p=0,00). La mayoría de las pacientes con complicaciones no planeó el embarazo (OR: 11 (IC 3,4-37,7), p=0,00) y no usó método anticonceptivo en esta gestación. El 70% recibió método anticonceptivo al egreso. CONCLUSIONES: Existen características clínicas asociadas a complicación en mujeres con aborto de manejo quirúrgico en nuestro centro, como diagnóstico de ingreso, embarazo no planificado, aborto previo y tipo de evacuación. Existen limitaciones en cuanto a la cantidad y calidad de información, sin embargo, nuestros resultados permiten conocer el perfil de pacientes atendidas por aborto en nuestro centro.

INTRODUCTION AND OBJECTIVES: In Chile, there are partial data regarding the prevalence of abortion. The migrant population has generated a change in the characteristics of patients in an abortion situation. The objective is to describe the demographic and clinical characteristics of women with surgical abortion with and without complications. METHODS: Transversal Descriptive Study. Women treated for abortion, undergoing evacuation method and who were admitted to the SIP / CLAP system were included. Women with or without complications were compared with respect to different demographic and clinical characteristics. Odd Ratio was calculated for some variables of interest. RESULTS: 554 women were included, 13% (N = 73) had complication at admission, mainly hemorrhagic (40%). Demographic characteristics were similar in both groups. There was an increased risk of complication in women with previous abortions (OR: 2.4 (IC 1.3-4.5), p = 0.00), when the diagnosis of admission was incomplete abortion (OR: 85.3 (IC 25.2- 288), p = 0.00) and when curettage was performed (OR: 4 (IC 2.5-6.5) p = 0.00). The majority of patients with complications did not plan pregnancy (OR: 11 (IC 3.4-37.7), p = 0.00) and did not use a contraceptive method in this pregnancy. 70% received contraceptive method upon discharge. CONCLUSIONS: There are clinical characteristics associated with complications in women with surgical management abortion in our center, such as admission diagnosis, unplanned pregnancy, previous abortion and type of evacuation. There are limitations regarding the quantity and quality of information, however, our results allow us to know the profile of patients treated for abortion in our center.

Prophylactic antibiotics for miscarriage surgery: A protocol for systematic review and meta-analysis.

BACKGROUND: Infection is a serious potential consequence of surgery to complete a spontaneous abortion. Antibiotic prophylaxis before some operations has been shown to reduce the risk of postoperative infections. However, for miscarriage surgery, evidence is lacking to show effectiveness. METHODS: In this systematic review, the electronic databases of Cochrane Central Register of Controlled Trials, EMBASE, and PUBMED will be searched from inception to May 1, 2020. Randomized controlled trials that assessed the effectiveness and safety of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery will be included. All process of the study selection, data extraction, and methodology evaluation will be carried out by two authors independently. RevMan 5.3 software will be utilized for statistical analysis. RESULTS: This study will provide a detailed summary of latest evidence related to the effectiveness and safety of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery. CONCLUSION: The findings of this study may provide possible guidance for the use of antibiotic prophylaxis for preventing infection for patients undergoing miscarriage surgery. DISSEMINATION AND ETHICS: Ethical approval is not required in this study, because it will not collect the original data from individual patient. The results are expected to publish through a peer-reviewed journal. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD CRD42020155643.

Gabapentin as an adjunct to paracervical block for perioperative pain management for first-trimester uterine aspiration: a randomized controlled trial.

BACKGROUND: Pain management approaches during uterine aspiration vary, which include local anesthetic, oral analgesics, moderate sedation, deep sedation, or a combination of approaches. For local anesthetic approaches specifically, we continue to have suboptimal pain control. Gabapentin as an adjunct to pain management has proven to be beneficial in gynecologic surgery. We sought to evaluate the impact of gabapentin on perioperative pain during surgical management of first-trimester abortion or early pregnancy loss with uterine aspiration under local anesthesia. OBJECTIVE: We hypothesized that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with uterine aspiration. Secondary outcomes included tolerability of gabapentin and postoperative pain, nausea, vomiting, and anxiety. STUDY DESIGN: We conducted a randomized double-blinded placebo-controlled trial of gabapentin 600 mg given 1 to 2 hours preoperatively among subjects receiving a first-trimester uterine aspiration under paracervical block in an outpatient ambulatory surgery center. There were 111 subjects randomized. The primary outcome was pain at time of uterine aspiration as measured on a 100-mm visual analog scale. Secondary outcomes included pain at other perioperative time points. To assess changes in pain measures, an intention to treat mixed effects model was fit with treatment groups (gabapentin vs control) as a between-subjects factor and time point as a within-subjects factor plus their interaction term. Because of a non-normal distribution of pain scores, the area under the curve was calculated for secondary outcomes with comparison of groups utilizing Mann-Whitney U tests. RESULTS: Among the 111 randomized, most subjects were Black or African American (69.4%), mean age was 26 years (±5.5), and mean gestational age was 61.3 days (standard deviation, 14.10). Mean pain scores at time of uterine aspiration were 66.77 (gabapentin) vs 71.06 (placebo), with a mean difference of -3.38 (P=.51). There were no significant changes in pain score preoperatively or intraoperatively. Subjects who received gabapentin had significantly lower levels of pain at 10 minutes after surgery (mean difference [standard error (SE)]=-13.0 [-5.0]; P=.01) and 30 minutes after surgery (mean difference [SE]=-10.8 [-5.1]; P=.03) compared with subjects who received placebo. Median nausea scores and incidence of emesis pre- and postoperatively did not differ between groups. Similarly, anxiety scores did not differ between groups, before or after the procedure. At 10 and 30 minutes after the procedure, most participants reported no side effects or mild side effects, and this did not differ between groups. CONCLUSION: Preoperative gabapentin did not reduce pain during uterine aspiration. However, it did reduce postoperative pain, which may prove to be a desired attribute of its use, particularly in cases where postoperative pain may be a greater challenge.

Serum progesterone levels could predict diagnosis, completion and complications of miscarriage.

BACKGROUND: Low serum progesterone levels were strongly correlated with miscarriages in several publications and with completion of miscarriage in one paper. This study evaluated several parameters, predominantly serum progesterone, as predictors for miscarriages, their swift non-surgical completion and their complications. BASIC PROCEDURES: Suspected or confirmed non-viable pregnancies with available concomitant serum progesterone measurements were retrospectively reviewed. The performance of serum progesterone, either alone or combined with other parameters, to predict viability, surgical removal and delay of non-surgical evacuation of non-viable pregnancy and complications, was analysed by logistic regression combined with Akaike and Bayesian information criteria, likelihood, receiver operated characteristic (ROC) curves, Mann-Whitney test and Fisher's exact test. MAIN FINDINGS: From 151 included pregnancies, 104 (68.9 %) were non-viable with 91 completions of miscarriage without surgery. The probability of viability was correlated linearly and curvilinearly with serum progesterone (p < 0.001). The probability of surgical removal, and the delay before non-surgical evacuation, showed a linear relationship with progesterone. No complication occurred when progesterone levels remained below 10 µg/L, while its rates were 9.5 % of non-viable pregnancies with progesterone levels between 10 and 20 µg/L and 26.7 % of cases with progesterone levels above 20 µg/L. Combined with progesterone, either "parity" or "history of miscarriage" improved the prediction of viability, "history of supra-isthmic uterine surgery" improved the prediction of surgery and "history of miscarriage" improved the prediction of delayed non-surgical evacuations. CONCLUSION: Serum progesterone can probably predict the odds of miscarriages, surgical removal, delayed non-surgical evacuation and complications, with potential improvements when different predictors are combined.

Increased Fetal Chromosome Detection with the Use of Operative Hysteroscopy During Evacuation of Products of Conception for Diagnosed Miscarriage.

STUDY OBJECTIVE: To determine whether incorporation of operative hysteroscopy with biopsy of products of conception, in conjunction with a suction curettage for a first trimester missed abortion, affected the rate of maternal cell contamination when chromosomal analysis was performed on the products of conception, and to determine the rates of retained products of conception with incorporation of hysteroscopy after suction curettage. DESIGN: Retrospective chart study. SETTING: Private, minimally invasive surgery and infertility practice with academic-community hospital affiliation. PATIENTS: Infertility patients undergoing evacuation of products of conception for documented first trimester miscarriages between 2006 and 2017. INTERVENTIONS: Suction curettage or hysteroscopic biopsy and suction curettage, followed by chromosomal analysis of products of conception for determination of fetal genetics. MEASUREMENTS AND RESULTS: A total of 264 charts were analyzed. Patients were categorized into 2 groups based on surgical collection of products of conception: group 1 (N = 174), suction curettage only, and group 2 (N = 90), a single procedure consisting of operative hysteroscopy with biopsy of products of conception followed by suction curettage and then diagnostic hysteroscopy to look for retained products. Data for chromosome detection and retained products of conception were available for 246 and 239 patients, respectively. No significant differences were detected between the groups for age, body mass index, ethnicity, gravida, parity, primary infertility, secondary infertility, spontaneous conception, single or multiple gestation, and surgical complications. Fetal chromosome detection was significantly higher without maternal contamination in group 2 (88.5%) compared with group 1 (64.8%) (p < .001). There was no significant between-group difference in postoperative retained products of conception. CONCLUSION: Obtaining fetal genetics can be useful when planning for a future successful pregnancy. The addition of operative hysteroscopy to biopsy the gestational sac, chorionic villi, and/or fetus significantly decreases the risk of maternal contamination and increases the ability to detect fetal chromosomes for genetic analysis without an increased risk of surgical complications. Despite the low risk of surgical complications, immediate second-look hysteroscopy after the completion of suction evacuation does not reduce the risk of postoperative retained products of conception.

Antibiotic prophylaxis in the surgical management of miscarriage in low-income countries: a cost-effectiveness analysis of the AIMS trial.

BACKGROUND: There is ongoing debate on the clinical benefits of antibiotic prophylaxis for reducing pelvic infection after miscarriage surgery. We aimed to study the cost-effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in low-income countries. METHODS: We did an incremental cost-effectiveness analysis using data from 3412 women recruited to the AIMS trial, a randomised, double-blind, placebo-controlled trial designed to evaluate the effectiveness of antibiotic prophylaxis in the surgical management of miscarriage in Malawi, Pakistan, Tanzania, and Uganda. Economic evaluation was done from a health-care-provider perspective on the basis of the outcome of cost per pelvic infection avoided within 2 weeks of surgery. Pelvic infection was broadly defined by the presence of clinical features or the clinically identified need to administer antibiotics. We used non-parametric bootstrapping and multilevel random effects models to estimate incremental mean costs and outcomes. Decision uncertainty was shown via cost-effectiveness acceptability frontiers. The AIMS trial is registered with the ISRCTN registry, number ISRCTN97143849. FINDINGS: Between June 2, 2014, and April 26, 2017, 3412 women were assigned to receive either antibiotic prophylaxis (1705 [50%] of 3412) or placebo (1707 [50%] of 3412) in the AIMS trial. 158 (5%) of 3412 women developed pelvic infection within 2 weeks of surgery, of whom 68 (43%) were in the antibiotic prophylaxis group and 90 (57%) in the placebo group. There is 97-98% probability that antibiotic prophylaxis is a cost-effective intervention at expected thresholds of willingness-to-pay per additional pelvic infection avoided. In terms of post-surgery antibiotics, the antibiotic prophylaxis group was US$0·27 (95% CI -0·49 to -0·05) less expensive per woman than the placebo group. A secondary analysis, a sensitivity analysis, and all subgroup analyses supported these findings. Antibiotic prophylaxis, if implemented routinely before miscarriage surgery, could translate to an annual total cost saving of up to $1·4 million across the four participating countries and up to $8·5 million across the two regions of sub-Saharan Africa and south Asia. INTERPRETATION: Antibiotic prophylaxis is more effective and less expensive than no antibiotic prophylaxis. Policy makers in various settings should be confident that antibiotic prophylaxis in miscarriage surgery is cost-effective. FUNDING: UK Medical Research Council, Wellcome Trust, and the UK Department for International Development.

Comparison of the diagnostic value of histopathological examinations of miscarriage products after pharmacological induction of miscarriage and curettage.

OBJECTIVES: For early miscarriage (pregnancy loss ≤ 12 weeks of gestation), two types of therapeutic treatment are offered (pharmacotherapy and curettage of the uterine cavity) depending on the presence and severity of clinical symptoms as well as patient choice. Our study aimed to assess the diagnostic value of the results of histopathological examinations of miscarriage products in relation to the administered treatments. MATERIAL AND METHODS: 850 medical records from patients diagnosed with missed miscarriage or empty gestational sac were analyzed retrospectively. Patients underwent surgical treatment or pharmacotherapy. Inefficacy of pharmacotherapy resulted in subsequent curettage. The results of histopathology were evaluated for their diagnostic value and classified: subgroup 1 - high value specimen (the studied specimen included fetal tissues, and villi), and subgroup 2 - no-diagnosis (the studied specimen included maternal tissues, autolyzed tissues, blood clots). Data were compared with chi-squared test. Differences was considered significant at p < 0.05. RESULTS: 1128 histopathological test results were analyzed; 569 (50.4%) were obtained during pharmacotherapy and 559 (49.6%) after curettage; out of the latter 497 after the initial pharmacotherapy and 62 after surgery. In the pharmacotherapy group, high value specimens comprised 231 cases (40.59%) while no diagnosis was obtained in 338 cases (59.4%). Considering specimens obtained in the course curettage, high value specimens were found in 364 cases (65.1%) while results that did not allow a diagnosis to be made were found in 195 cases (34.9%). CONCLUSIONS: Tissue specimens of high diagnostic value are obtained significantly more often during surgical treatment of miscarriage than during pharmacotherapy.

A Randomized Trial of Prophylactic Antibiotics for Miscarriage Surgery.

BACKGROUND: Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important complication of this surgery, particularly in low-resource countries. METHODS: We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics. RESULTS: We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval [CI], 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events. CONCLUSIONS: Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).

Medical versus surgical treatment of first trimester spontaneous abortion: A cost-minimization analysis.

BACKGROUND: Traditionally the gold-standard technique for the treatment of spontaneous abortion has been uterine evacuation by aspiration curettage. However, many studies have proposed medical treatment with misoprostol as an alternative to the conventional surgical treatment. The aim of this study was to apply cost minimization methods to compare the cost and effectiveness of the use of vaginal misoprostol as a medical treatment for first trimester spontaneous abortion with those of evacuation curettage as a surgical treatment. METHODOLOGY/PRINCIPAL FINDINGS: We present a longitudinal, prospective and quasi-experimental research study including a total of 547 patients diagnosed with first-trimester spontaneous abortion, in the period from January 2013 to December 2015. Patients were offered medical treatment with 800 mg vaginal misoprostol or evacuation curettage. Patients treated with misoprostol were followed-up at 7 days and a transvaginal ultrasound was performed to confirm the success of the treatment. If it failed, a second dose of 800 mg of vaginal misoprostol was prescribed and a new control ultrasound was performed. In case of failure of medical treatment after the second dose of misoprostol, evacuation curettage was indicated. The effectiveness of each of the treatment options was calculated using a decision tree. The cost minimization study was carried out by weighting each cost according to the effectiveness of each branch of the treatment. Of the 547 patients who participated in the study, 348 (64%) chose medical treatment and 199 (36%) chose surgical treatment. The overall effectiveness of medical treatment was 81% (283/348) and surgical treatment of 100%. The estimated final cost for medical treatment was € 461.92 compared to € 2038.72 for surgical treatment, which represents an estimated average saving per patient of € 1576.8. CONCLUSIONS/SIGNIFICANCE: Medical treatment with misoprostol is a cheaper alternative to surgery: in the Spanish Public Healthcare System, it is five times more inexpensive than curettage. Given its success rates higher than 80%, mild side effects, controllable with additional medication and the high degree of overall satisfaction, it should be prioritized over the evacuation curettage in patients who meet the treatment criteria.