TY - JOUR
T1 - Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage
T2 - follow-up of a randomized controlled trial
AU - Hooker, Angelo B.
AU - de Leeuw, Robert A.
AU - Twisk, Jos W.R.
AU - Brölmann, Hans A.M.
AU - Huirne, Judith A.F.
N1 - Funding Information: Supported by the Foundation for Scientific Investigation in Obstetrics and Gynecology of the Saint Lucas Andreas Hospital (now called OLVG Oost). The syringes containing ACP gel were received from Anika Therapeutics. The funder and sponsor of the prospective RCT had no role in study design, data collection, data analysis, data interpretation, trial design, patient recruitment, writing of the current report, or any aspect pertinent to the follow-up study. Publisher Copyright: © 2020 The Authors Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/9
Y1 - 2020/9
N2 - Objective: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. Design: Follow-up of a prospective randomized trial. Setting: University and university-affiliated teaching hospitals. Patient(s): Women with a miscarriage at <14 weeks’ gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8–12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. Intervention(s): Participants received a questionnaire 30 months after treatment. Main Outcome Measure(s): Ongoing pregnancy and outcome of subsequent pregnancies. Result(s): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. Conclusion(s): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. Dutch Clinical Trial Registry Number: NTR 3120.
AB - Objective: To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes. Design: Follow-up of a prospective randomized trial. Setting: University and university-affiliated teaching hospitals. Patient(s): Women with a miscarriage at <14 weeks’ gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8–12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed. Intervention(s): Participants received a questionnaire 30 months after treatment. Main Outcome Measure(s): Ongoing pregnancy and outcome of subsequent pregnancies. Result(s): Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively. Conclusion(s): Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs. Dutch Clinical Trial Registry Number: NTR 3120.
KW - Intrauterine adhesions
KW - dilation and curettage
KW - hyaluronic acid
KW - miscarriage
KW - reproductive outcome
UR - http://www.scopus.com/inward/record.url?scp=85087742620&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.fertnstert.2020.04.021
DO - https://doi.org/10.1016/j.fertnstert.2020.04.021
M3 - Article
C2 - 32660725
SN - 0015-0282
VL - 114
SP - 601
EP - 609
JO - Fertility and Sterility
JF - Fertility and Sterility
IS - 3
ER -