Dataset Information

Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial.

ABSTRACT: Intrauterine adhesion (IUA), fibrosis, and scarring resulting from damage to the endometrium is a rare but serious clinical disease, contributing to a significant impairment of reproductive function. Uterine instrumentation, especially that of a hysteroscopic myomectomy, has become the main cause of IUA. Therefore, a prospective randomized controlled study to assess the effectiveness and short-term safety of the use of hyaluronic acid gels in the prevention of IUA after a hysteroscopic myomectomy and an evaluation of the characteristics of IUA observed at follow-up are presented here. A total of 70 patients were analyzed at the end of 16 March 2020. The results show that the incidence of IUA in women who underwent a hysteroscopic myomectomy is 21.4% (15/70), overall. Women treated with hyaluronic acid gels have a statistically significantly lower incidence of IUAs than non-treated women (12.8% vs. 39.1%, p = 0.012). In addition, women in the anti-adhesive gel treatment group had a dramatically reduced severity of IUA than women in the no-treatment group (p = 0.002). Further analysis shows that the International Federation of Gynecology and Obstetrics (FIGO) classification type and the use of anti-adhesive gels are independent factors associated with moderate and severe degrees of IUA formation. The results here highlight the significant therapeutic benefits of the application of hyaluronic acid gels in women undergoing a hysteroscopic myomectomy, especially for those patients with a uterine myoma classified as FIGO type 2. Since the risk of IUA after a hysteroscopic myomectomy is high, especially for patients who have not received prophylactic anti-adhesive gels, the application of hyaluronic acid gels as a prevention strategy is highly recommended. More studies are encouraged to confirm our observation.

SUBMITTER: Huang CY

PROVIDER: S-EPMC7280993 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial.

Huang Chen-Yu CY Chang Wen-Hsun WH Cheng Min M Huang Hsin-Yi HY Horng Huann-Cheng HC Chen Yi-Jen YJ Lee Wen-Ling WL Wang Peng-Hui PH

Life (Basel, Switzerland) 20200515 5

Intrauterine adhesion (IUA), fibrosis, and scarring resulting from damage to the endometrium is a rare but serious clinical disease, contributing to a significant impairment of reproductive function. Uterine instrumentation, especially that of a hysteroscopic myomectomy, has become the main cause of IUA. Therefore, a prospective randomized controlled study to assess the effectiveness and short-term safety of the use of hyaluronic acid gels in the prevention of IUA after a hysteroscopic myomectom ...[more]

PMID: 32429137

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Project description:ObjectiveReproductive aged women with fibroids must weigh the risks and benefits of preconception myomectomy. Women with fibroids may have higher rates of fetal growth restriction (FGR) and stillbirth; however, there is a paucity of data on the impact of myomectomy on pregnancy outcomes. We compared perinatal outcomes in women with prior myomectomy versus those with no prior myomectomy and at least one fibroid ≥ 5 cm.MethodsRetrospective cohort study of women at a single center who delivered between 2008 and 2017 with a viable intrauterine pregnancy at initial ultrasound scan and either prior myomectomy, or, in the no-myomectomy cohort, at least one fibroid ≥ 5 cm on a prenatal scan performed at < 21 weeks' gestation (wga). Pregnancies complicated by major congenital anomalies were excluded. Primary outcome was preterm birth (PTB) < 37wga. Secondary outcomes included rates of spontaneous loss, cesarean delivery (CD), abnormal placentation, malpresentation, FGR, birthweight, birthweight percentile, estimated blood loss (EBL), blood transfusion, and neonatal survival to discharge.ResultsA total of 290 women met inclusion criteria: 70 had a prior myomectomy, 220 women had ≥1 fibroid ≥5cm. Women with prior myomectomy were older, more likely to have private insurance, and more likely used artificial reproductive technology to conceive; 20% with prior myomectomy still had at least one ≥ 5 cm myoma on their obstetric scan. Rates of spontaneous loss were lower in the prior myomectomy group (1.4% vs 7.3%; p = .08). Of the 273 pregnancies continuing beyond 20 weeks, women with prior myomectomy had significantly more PTBs (35% vs. 21%, p = .02) and significantly different primary birth indications (p < .0001). However, after controlling for late preterm, prelabor cesareans recommended by providers in the myomectomy cohort, the difference in PTB rates was not significant (p = .13). The myomectomy group had more CDs (88% vs. 53%, p < .0001), higher EBL (1250 mL vs. 811 mL, p = .04), and a trend toward more blood transfusions (16% vs 8%, p = .05). Other selected outcomes were similar, including rates of FGR.ConclusionsWomen with prior myomectomy had significantly more PTBs, due in part to more preterm, prelabor cesareans in the late preterm period. Otherwise, prior myomectomy did not confer appreciable obstetric or perinatal benefits, as patients had more CDs, and higher EBL. Recommendations to perform preterm prelabor cesareans in this population may explain some of the PTB disparity. The effect of prior myomectomy on early pregnancy loss and infertility requires further study.

Project description:The electrothermal effect of hysteroscopic bipolar electrosurgical resection may cause damage to the endometrium, leading to intrauterine adhesion (IUA). Although some studies have demonstrated the efficacy and feasibility of auto-cross-linked hyaluronic (ACP) gel in preventing IUAs, controversy over its use continues. In this randomized controlled multi-center 2-arm parallel trial, we aimed to examine the efficacy and safety of ACP gel in preventing IUA after hysteroscopic electrosurgical resection and facilitate pregnancy in patients. Patients from 4 centers in China were randomly assigned (1:1) to receive an intrauterine infusion of ACP gel or nothing after hysteroscopic electrosurgical resection. The randomization assignment was generated by computer and kept in a sealed envelope. A second-look hysteroscopy was performed within 3 months of the surgery. From June 2018 to May 2021, 200 patients were recruited. Ultimately, 82 patients in both groups were included in the result analysis. The baseline characteristics were comparable. The outcomes were assessed by using per-protocol analysis. The incidence of IUA in the ACP gel group was lower than that in the control group [3.66% vs. 10.98%, risk ratio (RR) =0.333, 95% confidence interval (CI): 0.094-1.187, P=0.072], and the planned pregnancy rate was higher than that of the control group (60.98% vs. 40.54%, RR =1.504, 95% CI: 0.949-2.384, P=0.071), but the difference was not statistically significant. There was no significant difference in menstruation change. Menstrual volume remained unchanged in most cases (86.59% in ACP gel group vs. 89.02% in the control group, RR =0.877, 95% CI: 0.877-1.109, P=0.815). Menstrual volume decreased in 10 women in the ACP gel group and 8 in the control group (12.20% vs. 9.76%, RR =1.250, 95% CI: 0.520-3.007, P=0.617). No adverse effects were observed after the ACP administration. The present study showed that the use of ACP gel appeared to reduce both the tendency of IUA and American Fertility Society (AFS) scores and improve the subsequent pregnancy rate during hysteroscopic electrosurgical resection when treating polyps, fibroids, and uterine septum. ACP might be recommended to prevent IUA after such surgery. Further studies should be conducted with larger numbers of participants. Chinese Clinical Trial Registry ChiCTR2100047165.

Dataset Information

Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial.

Publications

Crosslinked Hyaluronic Acid Gels for the Prevention of Intrauterine Adhesions after a Hysteroscopic Myomectomy in Women with Submucosal Myomas: A Prospective, Randomized, Controlled Trial.

Similar Datasets

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