New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial.J Minim Invasive Gynecol. 2019 01; 26(1):94-99.JM
To evaluate the efficacy of a new crosslinked hyaluronan (NCH) gel in reducing the formation of intrauterine adhesions (IUAs) after dilation and curettage (D&C).
Randomized controlled trial (Canadian Task Force classification I).
Six hospitals for maternal and child healthcare in China.
A total of 300 patients were randomized to undergo D&C for delayed miscarriage without previous history of D&C. Twenty-six patients (9%) were lost to follow-up and were excluded from the analysis.
Women were randomly assigned to D&C alone (control group; n = 150) or D&C plus NCH gel application (NCH gel group; n = 150) with 1:1 allocation.
MEASUREMENTS AND MAIN RESULTS
All patients were evaluated using the American Fertility Society classification of IUAs during follow-up diagnostic hysteroscopy, scheduled at 3 months after D&C procedure. The primary endpoint was the number of women with IUAs at 3 months, and the secondary endpoints were adhesion scores and severity of IUAs. Postoperative efficacy data were available for 274 women (137 in each group). Intrauterine adhesion formations were observed in 13 of the 137 women (9.5%) in the NCH gel group and in 33 of the 137 women (24.1%) in the control group (p = .0012; relative risk [RR], 0.3939; 95% confidence interval [CI], 0.2107-0.7153), a difference of 14.6% (95% CI, 5.92%-23.28%) between the 2 groups. The extent of intrauterine cavity involved, type of adhesion and menstrual pattern, and cumulative adhesion scores were significantly lower in the NCH gel group compared with the control group (p = .0007, .008, .0012, and .0006, respectively). The proportion of women with moderate to severe IUAs was significantly lower in the NCH gel group than that in the control group (1 of 137 [0.7%] vs 16 of 137 [11.7%]; p = .0002; RR, 0.0625; 95% CI, 0.0084-0.4648), a difference of 11.95% (95% CI, 5.39%-16.51%) between the 2 groups.
The current study demonstrates that IUAs are frequently formed after D&C for delayed miscarriage in women without a previous history of D&C procedures, and the application of NCH gel significantly reduces IUA formation.