Surgical treatment and reproductive outcomes in caesarean scar pregnancy at a single center.

BACKGROUND: To investigate factors associated with different reproductive outcomes in patients with Caesarean scar pregnancies (CSPs). METHODS: Between May 2017 and July 2022, 549 patients underwent ultrasound-guided uterine aspiration and laparoscopic scar repair at the Gynaecology Department of Hubei Maternal and Child Health Hospital. Ultrasound-guided uterine aspiration was performed in patients with type I and II CSPs, and laparoscopic scar repair was performed in patients with type III CSP. The reproductive outcomes of 100 patients with fertility needs were followed up and compared between the groups. RESULTS: Of 100 patients, 43% had live births (43/100), 19% had abortions (19/100), 38% had secondary infertility (38/100), 15% had recurrent CSPs (RCSPs) (15/100). The reproductive outcomes of patients with CSPs after surgical treatment were not correlated with age, body mass index, time of gestation, yields, abortions, Caesarean sections, length of hospital stay, weeks of menopause during treatment, maximum diameter of the gestational sac, thickness of the remaining muscle layer of the uterine scar, type of CSP, surgical method, uterine artery embolisation during treatment, major bleeding, or presence of uterine adhesions after surgery. Abortion after treatment was the only risk factor affecting RCSPs (odds ratio 11.25, 95% confidence interval, 3.302-38.325; P < 0.01) and it had a certain predictive value for RCSP occurrence (area under the curve, 0.741). CONCLUSIONS: The recurrence probability of CSPs was low, and women with childbearing intentions after CSPs should be encouraged to become pregnant again. Abortion after CSP is a risk factor for RCSP. No significant difference in reproductive outcomes was observed between the patients who underwent ultrasound-guided uterine aspiration and those who underwent laparoscopic scar repair for CSP.

Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration.

BACKGROUND: Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures-strategies that differ in patient experience, effectiveness, and cost. One of the medications used for early pregnancy loss treatment, mifepristone, is uniquely regulated by the Food and Drug Administration. OBJECTIVE: This study aimed to compare the cost-effectiveness from the healthcare sector perspective of medical management of early pregnancy loss, using the standard of care medication regimen of mifepristone and misoprostol, with that of office uterine aspiration. STUDY DESIGN: We developed a decision analytical model to compare the cost-effectiveness of early pregnancy loss treatment with medical management with that of office uterine aspiration. Data on medical management came from the Pregnancy Failure Regimens randomized clinical trial, and data on uterine aspiration came from the published literature. The analysis was from the healthcare sector perspective with a 30-day time horizon. Costs were in 2018 US dollars. Effectiveness was measured in quality-adjust life-years gained and the rate of complete gestational sac expulsion with no additional interventions. Our primary outcome was the incremental cost per quality-adjust life-year gained. Sensitivity analysis was performed to identify the key uncertainties. RESULTS: Mean per-person costs were higher for uterine aspiration than for medical management ($828 [95% confidence interval, $789-$868] vs $661 [95% confidence interval, $556-$766]; P=.004). Uterine aspiration more frequently led to complete gestational sac expulsion than medical management (97.3% vs 83.8%; P=.0001); however, estimated quality-adjust life-years were higher for medical management than for uterine aspiration (0.082 [95% confidence interval, 0.8148-0.08248] vs 0.079 [95% confidence interval, 0.0789-0.0791]; P<.0001). Medical management dominated uterine aspiration, with lower costs and higher confidence interval. The probability that medical management is cost-effective relative to uterine aspiration is 97.5% for all willingness-to-pay values of ≥$5600/quality-adjust life-year. Sensitivity analysis did not identify any thresholds that would substantially change outcomes. CONCLUSION: Although office-based uterine aspiration more often results in treatment completion without further intervention, medical management with mifepristone pretreatment costs less and yields similar quality-adjust life-years, making it an attractive alternative. Our findings provided evidence that increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care.

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.

Management of cesarean scar ectopic pregnancies at an academic referral center: A case series.

OBJECTIVES: To describe treatment and outcomes of patients with confirmed cesarean scar ectopic pregnancy (CSEP) at a tertiary referral center. STUDY DESIGN: We reviewed a deidentified family planning clinical database for patients seen by our subspecialty service for CSEP from January 2017 through December 2021 in this case series. We extracted referral information, final diagnosis, management, and outcome measures including estimated blood loss, secondary procedures, and treatment complications. RESULTS: Of 57 cases referred for suspected CSEPs, 23 (40%) had confirmed diagnoses; one additional case was diagnosed during clinic evaluation for early pregnancy loss. Most (n = 50 [88%]) referrals occurred in the last 2 years of the 5-year study period. Of 24 confirmed CSEP cases, eight were pregnancy losses at the time of diagnosis. Fourteen cases were ≤50 days gestation or gestational size (7 [50%] pregnancy losses) and 10 >50 days gestation (range 39-66 days). We treated all 14 patients ≤50 days primarily with suction aspiration under ultrasound guidance in an operating room with no complications and estimated blood loss of 14 ± 10 mL. Of the 10 patients>50 days (maximum 66 days), seven were managed with primary aspiration of which five were uncomplicated. We treated one patient (57 days) had primary intrauterine double-catheter balloon with immediate hemorrhage requiring uterine artery embolization followed by an uncomplicated suction aspiration. CONCLUSIONS: Patients with confirmed CSEPs at 50 days or less gestation or gestational size can likely be primarily treated with suction aspiration with low risk for significant adverse outcomes. Treatment success and complications are directly related to gestational age at treatment. IMPLICATIONS: Ultrasound-guided suction aspiration monotherapy should be considered for primary CSEP treatment up to 50 days and, with continued experience, may be reasonable beyond 50 days gestation. Invasive treatments or those that require multiple days and visits, such as methotrexate or balloon catheters, are not necessary for early CSEPs.

Medication abortion and uterine aspiration for undesired pregnancy of unknown location: A retrospective cohort study.

OBJECTIVE: To compare days to diagnosis of pregnancy location for same-day medication abortion and same-day uterine aspiration with delayed treatment (expectant management) in patients with undesired pregnancy of unknown location (PUL). STUDY DESIGN: We conducted a retrospective cohort study at a single Planned Parenthood health center in Minnesota. We reviewed electronic health records and included patients presenting for induced abortion diagnosed with PUL (positive high-sensitivity urine pregnancy test and no evidence of intrauterine or extrauterine pregnancy on transvaginal ultrasonography) without symptoms or ultrasonographic imaging concerning for ectopic pregnancy (low risk). The primary outcome was days to pregnancy location clinical diagnosis. RESULTS: Of 19,151 abortion encounters in 2016-2019, 501 (2.6%) had a low-risk PUL. Participants chose delay-for-diagnosis before treatment (148, 29.5%), immediate treatment medication abortion (244, 48.7%), or immediate treatment uterine aspiration (109, 21.8%). Median days to diagnosis were significantly lower in the immediate treatment uterine aspiration group (2 days, IQR 1-3 days, p < 0.001) and similar for immediate treatment medication abortion (4 days, IQR 3-9 days, p = 0.304) compared with delay-for-diagnosis (3 days, IQR 2-10 days). Thirty-three low-risk participants (6.6%) were treated for ectopic pregnancy, but no difference in ectopic rate was detected among groups (p = 0.725). Participants in the delay-for-diagnosis group were more likely to be nonadherent with follow-up (p < 0.001). For participants who completed follow-up, abortion completion rate was lower for immediate treatment medication abortion (85.2%) compared with immediate treatment uterine aspiration (97.6%, p = 0.003). CONCLUSIONS: For patients with undesired PUL, diagnosis of pregnancy location was fastest with immediate treatment uterine aspiration and similar for expectant management and immediate treatment medication abortion. Medication abortion efficacy may be reduced in treatment of undesired PUL. IMPLICATIONS: For PUL patients desiring induced abortion, the option of proceeding at initial encounter may help improve access and patient satisfaction. Uterine aspiration for PUL may help diagnose pregnancy location more quickly.

ED50 and ED95 of Propofol Combined with Different Doses of Intravenous Lidocaine for First-Trimester Uterine Aspiration: A Prospective Dose-Finding Study Using Up-and-Down Sequential Allocation Method.

Purpose: This study aimed to test the effect of different doses of intravenous lidocaine on the median effective dose (ED50) and 95% effective dose (ED95) of propofol-induction dose and identify the optimal dose. Patients and Methods: Patients undergoing first-trimester uterine aspiration were screened and randomly enrolled into the following groups: saline (L0), 0.5 mg/kg lidocaine (L0.5), 1.0 mg/kg lidocaine (L1.0), and 1.5 mg/kg lidocaine (L1.5). Anesthesia was induced with 1.0 µg/kg fentanyl. Prepared lidocaine or saline solution was injected later according to allocation, followed by propofol. The dose of propofol for each patient was determined using the up-and-down sequential study design. The primary end point was the ED50 and ED95 of the propofol-induction dose. The total propofol doses, awakening time, and adverse events were recorded. Results: The ED50 (95% confidence interval) of propofol was significantly lower in groups L1.0 and L1.5 than group L0 (1.6 [1.5-1.7] mg/kg and 1.8 [1.6-1.9] mg/kg, versus 2.4 [2.3-2.5] mg/kg, respectively; p<0.001). There was no significant difference in ED50 between groups L1.0 and L1.5 (p>0.05). However, surprisingly, the ED50 was significantly higher in group L0.5 than L0 (2.8 [2.6-3.0] mg/kg vs 2.4 [2.3-2.5] mg/kg; p<0.05). The total doses of propofol in groups L1.0 and L1.5 were lower than those in groups L0 and L0.5 (p<0.05). The systolic blood pressure (SBP) decline after anesthesia induction in group L0.5 was greater than that in group L0 (p<0.01). The incidence of respiratory depression in group L0.5 was greater than that in groups L0 and L1.0 (p<0.05). Conclusion: In patients who underwent first-trimester uterine aspiration, intravenous lidocaine 1.0 mg/kg prior to propofol injection significantly reduced the ED50 of propofol induction dose without severe side effects, equivalent to the effect of 1.5 mg/kg dose. We recommend 1.0 mg/kg as the optimal dose.

Lower and extended dosage of misoprostol for cervical ripening in 1st trimester miscarriage (MISO200): A randomized clinical trial.

OBJECTIVE: To compare the efficacy of priming the uterine cervix before Manual Vaccum Aspiration (MVA) using 200 µg or 400 µg of vaginal misoprostol, inserted a mean time of 6 h before MVA in first trimester miscarriage. STUDY DESIGN: Randomized, triple-blind, non-inferiority clinical trial. Patients between 18 and 50 years old, with a diagnosis of miscarriage, were eligible for the study. Patients were allocated to receive either 200 µg or 400 µg of misoprostol before the MVA. The primary outcome was the need to dilate the uterine cervix with mechanical dilators (Hegar dilators). As a secondary outcome, cervical dilatation ≥8 mm before the procedure was considered successful. A difference of <25% was considered as non-inferior. RESULTS: Between December 21, 2016 and October 6, 2019, 269 women were screened. After screening, 105 and 106 women received 200 µg and 400 µg of misoprostol, respectively. Mechanical cervical dilatation was not necessary in 84.8% (95%CI 77% to 90%) and 96.2% (95%CI 91% to 99%), in the 200 µg and 400 µg groups, respectively [difference = 11.5% (95%CI 3.7% to 19.2%). Cervical dilatation of ≥8 mm was 52.4% (95%CI 42.9% to 61.7%) in the 200 µg misoprostol group, while in the 400 µg group was 71.7% (95%CI 62.5% to 79.4%) [difference = 19.3% (95%CI 6.5 to 32.2). CONCLUSION: After a mean time of 6 h, 200 µg of vaginal misoprostol is not inferior to 400 µg of misoprostol for cervical priming before MVA, in first trimester miscarriage. This non-inferiority was not observed when the ≥8 mm criterion was considered.

Management of heterotopic pregnancy with uterine aspiration and systemic two-dose methotrexate.

The expected trend in serum beta-human chorionic gonadotropin (ß-hCG) following treatment of an undesired heterotopic pregnancy with uterine aspiration and systemic methotrexate is not known. Thus, monitoring for treatment success is challenging. We describe an undesired heterotopic pregnancy treated with aspiration and two-dose methotrexate and report the observed ß-hCG trend.

First-Trimester Abortion Complications: Simulation Cases for OB/GYN Residents in Sepsis and Hemorrhage.

Introduction: Serious complications associated with first-trimester abortions are rare. The US mortality rate for these procedures is 0.7 per 100,000, primarily due to infection and hemorrhage. While complications are unlikely to arise during training, residents must be prepared to manage them in practice. To address this, we developed a 2-hour simulation-based abortion complication curriculum for OB/GYN resident learners. Methods: OB/GYN residents participated in three sessions: a case-based didactic reviewing institutional aspiration abortion practice and preop preparation; an in-vivo aspiration abortion hemorrhage simulation; and an interdepartmental postabortal sepsis simulation. Participants completed surveys before and after their participation that evaluated clinical knowledge, and self-rated competence in, and preparedness for, managing first-trimester abortion complications. Results: Resident learners (N = 26) represented all four classes of OB/GYN residents. Residents initially showed stronger clinical knowledge in managing postabortal hemorrhage than sepsis (90% vs. 62%, p < .001). Clinical knowledge improved following the sepsis simulation (62% to 91%, p < .001), and remained strong but unchanged after the hemorrhage simulation (90% to 87%, p = .3). Resident self-assessments of competence and preparedness were significantly improved after both the hemorrhage (p = .006) and sepsis (p = .002) simulations. Learners reported that the simulation increased their level of comfort in managing these complications in their future practice. Discussion: Postabortal hemorrhage and sepsis simulations increased OB/GYN residents' knowledge, comfort, and preparedness for managing rare complications of first-trimester abortions. In-vivo simulation and interdepartmental collaboration were novel aspects of these simulations that may facilitate increased preparedness and management skills.

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15-18 weeks' gestation: a randomised controlled non-inferiority trial.

OBJECTIVE: Cervical preparation is recommended prior to second-trimester surgical abortion. Osmotic dilators are an effective means to prepare the cervix, but require an additional procedure and may cause discomfort. We compared cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators. STUDY DESIGN: A randomised, controlled, non-inferiority trial was performed to compare cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators in women undergoing surgical abortion between 15 and 18 weeks gestation. The medication group (n=29) received mifepristone 200 mg orally 24 hours prior to uterine evacuation and misoprostol 400 µg buccally 2 hours before the procedure. The dilator group (n=20) underwent osmotic dilator insertion 24 hours prior to the procedure. The primary outcome was total procedure time, from insertion to removal of the speculum. Secondary outcomes included operative time (from intrauterine instrumentation to speculum removal), initial cervical dilation, nausea, pain, ease of procedure, and whether participants would choose the same modality in the future. RESULTS: For mean total procedure time, medication preparation (14.0 min, 95% CI 12.0-16.1) was not inferior to dilators (14.3 min, 95% CI 11.7 to 16.8, p<0.001). Mean operative time and ease of procedure were also similar between groups. More women in the medication group than the dilator group would prefer to use the same method in the future (86% vs 30%, p=0.003). CONCLUSION: Prior to surgical abortion at 15-18 weeks, use of mifepristone and misoprostol did not result in longer procedure times than overnight osmotic dilators. TRIAL REGISTRATION NUMBER: NCT01462.

Discovery of biomarkers of endometrial receptivity through a minimally invasive approach: a validation study with implications for assisted reproduction.

OBJECTIVE: To determine whether a minimally invasive approach to sampling endometrial cells that can be applied during an active conception cycle can generate robust biomarker candidates for endometrial receptivity by genomewide gene expression profiling. DESIGN: Longitudinal study comparing gene expression profiles of cells isolated from uterine aspirates collected during the prereceptive and receptive phases of a natural cycle. SETTING: University-affiliated hospital. PATIENT(S): Healthy volunteers, ≤40 years of age, with regular menstrual cycles and no history of infertility. INTERVENTION(S): One menstrual cycle monitored with urinary kits to identify the luteinizing hormone (LH) surge; uterine aspirations collected at LH + 2 days (LH + 2) and at LH + 7; endometrial biopsy obtained on LH + 7; RNA extraction from the cellular material for gene expression profiling, and differential gene expression validated by NanoString assay and cross-validated against a publically available data set. MAIN OUTCOME MEASURE(S): Differentially expressed genes between LH + 2 and LH + 7 samples. RESULT(S): NanoString assay validated 96% of the 245 genes found differentially expressed at LH + 7. Unsupervised hierarchical clustering of aspiration and biopsy samples demonstrated the concordance of the sampling methods. A predictor gene cassette derived by a shrunken centroid class prediction technique correctly classified the receptive phase within an external data set. CONCLUSION(S): Uterine aspiration, which can be performed during an active conception cycle, identified robust candidate biomarkers of endometrial receptivity, and will enable their validation by direct correlation with clinical outcomes.

Pain relief for obstetric and gynecologic ambulatory procedures.

As minor gynecologic procedures move from the operating room to the office, providers need to ensure that patients are comfortable and that procedures are performed safely. Although local anesthesia is commonly used for gynecologic procedures, a multimodal approach may be more effective. If necessary, sedation can be safely provided in an office setting with the correct tools and training. This article reviews evidence-based approaches to pain management for gynecologic procedures in the ambulatory setting.