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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

Abstract

STUDY OBJECTIVES

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).

DESIGN

Randomized controlled trial (Canadian Task Force classification I).

SETTINGS

Six hospitals for maternal and child healthcare in China.

PATIENTS

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.

INTERVENTIONS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Department of Obstetrics, Hunan Province Maternal and Child Health Care Hospital, Changsha, Hunan, China.Department of Obstetrics, Hunan Province Maternal and Child Health Care Hospital, Changsha, Hunan, China.The Women's Health Center, Changsha Hospital for Maternal and Child Health Care, Changsha, Hunan, China.The Women's Health Center, Changsha Hospital for Maternal and Child Health Care, Changsha, Hunan, China.Department of Obstetrics, The Maternal and Child Health Care Hospital of Hengyang City, Hengyang, Hunan, China.Department of Obstetrics, The Maternal and Child Health Care Hospital of Hengyang City, Hengyang, Hunan, China.Department of Obstetrics, The Maternal and Child Health Care Hospital of Changde City, Changde, Hunan, China.Department of Obstetrics, The Maternal and Child Health Care Hospital of Changde City, Changde, Hunan, China.Department of Obstetrics, Huaihua City Maternal and Child Health Care Hospital, Huaihua, Hunan, China.Department of Obstetrics, Yueyang Maternal and Child Health-Care Hospital, Yueyang, Hunan, China.Department of Obstetrics and Gynecology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China. Electronic address: xueminxy3@163.com.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29678756

Citation

Li, Xueying, et al. "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." Journal of Minimally Invasive Gynecology, vol. 26, no. 1, 2019, pp. 94-99.
Li X, Wu L, Zhou Y, et al. 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;26(1):94-99.
Li, X., Wu, L., Zhou, Y., Fan, X., Huang, J., Wu, J., Yu, R., Lou, J., Yang, M., Yao, Z., & Xue, M. (2019). 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. Journal of Minimally Invasive Gynecology, 26(1), 94-99. https://doi.org/10.1016/j.jmig.2018.03.032
Li X, et al. 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;26(1):94-99. PubMed PMID: 29678756.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Li,Xueying, AU - Wu,Ling, AU - Zhou,Yanfei, AU - Fan,Xing, AU - Huang,Jufang, AU - Wu,Juhua, AU - Yu,Renxiu, AU - Lou,Jianying, AU - Yang,Mengjie, AU - Yao,Zhihong, AU - Xue,Min, Y1 - 2018/04/17/ PY - 2018/01/03/received PY - 2018/02/24/revised PY - 2018/03/05/accepted PY - 2018/4/22/pubmed PY - 2019/7/19/medline PY - 2018/4/22/entrez KW - American Fertility Society classification KW - Crosslinked hyaluronan gel KW - Hyaluronic acid gel SP - 94 EP - 99 JF - Journal of minimally invasive gynecology JO - J Minim Invasive Gynecol VL - 26 IS - 1 N2 - STUDY OBJECTIVES: 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). DESIGN: Randomized controlled trial (Canadian Task Force classification I). SETTINGS: Six hospitals for maternal and child healthcare in China. PATIENTS: 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. INTERVENTIONS: 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. CONCLUSIONS: 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. SN - 1553-4669 UR - https://www.unboundmedicine.com/medline/citation/29678756/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1553-4650(18)30220-6 DB - PRIME DP - Unbound Medicine ER -