Abstract
OBJECTIVE: Intrauterine balloons are often used to prevent adhesion reformation after hysteroscopic adhesiolysis (HA). The effect of the intrauterine balloon residence time on reproductive outcomes remains unclear. The present study aimed to investigate the reproductive outcomes of different intrauterine balloon residence times after HA in patients with intrauterine adhesions (IUAs). METHODS: A comprehensive literature search was conducted in the PubMed, Web of Science, and Embase databases, spanning from their respective inception dates to June 2024.The reference lists of relevant studies were also searched. Randomised controlled trials (RCTs) in english comparing more than one week versus one week of intrauterine balloon use following operative hysteroscopy among women with intrauterine adhesions were included. The primary outcomes were the live birth rate (LBR), pregnancy rate (PR), and reformation rate (RR) of intrauterine adhesions. DATA COLLECTION AND ANALYSIS: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of the included articles was assessed using the Jadad score. RESULTS: The overall quality of evidence was low to moderate. A major limitation of this study lies in the risk of bias present in the included research. Specifically, allocation concealment, blinding procedures, and outcome imprecision were not reported in some of the included studies. A total of 10 randomized controlled trials (RCTs) were identified. Among these, relative risks (RRs) were reported in 9 studies, pregnancy rates (PRs) in 7 studies, and live birth rates (LBRs) in 5 studies. The pooled RR, PR, and LBR were compared between the experimental group (intrauterine balloon indwelling for more than 1 week) and the control group (intrauterine balloon indwelling for 1 week). The log OR of event occurrence in the experimental group (Balloon placement duration of more than one week) was lower than that in the control group (Balloon placement duration of one week), and the balloon placement duration for more than one week may have a certain protective effect on the recurrence of intrauterine adhesions (pooled log OR of - 0.51, 95% confidence interval (CI): [-0.85, - 0.17], with heterogeneity I2 = 45.19 %, p value = 0.07). Subgroup analyses were performed. In the "Balloon" subgroup, the RR outcomes for Foley Balloon were as follows: log OR = -0.74, 95% CI [-1.12, -0.36], p-value = 0.000. For Cook balloon (Heart-shaped), the outcomes were: log OR = -0.36, 95% CI [-0.86, 0.15], p-value = 0.168. The log OR for the occurrence of the pregnant event in the experimental group was lower than that in the control group, and the balloon placement duration for more than one week may have a certain negative effect on the pregnant rate. (pooled log OR = 0.35, 95% CI [0.04, 0.66], with heterogeneity I2 = 0.00 %, p-value = 0.78.). Subgroup analyses were performed. In the "Balloon" subgroup, the PR outcomes for Foley Balloon were as follows: log OR = 0.19, 95% CI [-0.39, 0.77], p-value = 0.519. For Cook balloon (Heart-shaped), the outcomes were: log OR = 0.41, 95% CI [0.04, 0.78], p-value = 0.029. There was no clear evidence of a difference in the live birth rate (LBR) between intrauterine balloon placement for more than one week and that for one week. (pooled log OR of 0.28, 95% CI: [-0.09-0.65], with low heterogeneity I2 = 16.24%, p value = 0.31). Subgroup analyses were performed. In the "Balloon" subgroup, the LBR outcomes for Foly balloon were as follows: log OR = -0.22, 95% CI [-0.91, 0.48], p-value = 0.539. For the Cook Balloon (Heart-shaped), the outcomes were: log OR = 0.48, 95% CI [0.04, 0.91], p-value = 0.032. CONCLUSIONS: In woman with moderate-to-severe intrauterine adhesions (IUA), Foley balloon placement for more than one week may be more effective than Foley balloon placement for one week in reducing IUA recurrence following operative hysteroscopy. However, for the Cook balloon, there was no significant different between one week placement and more than one week on reducing IUA recurrence; Cook balloon (heart-shaped) placement for more than one week may exert a certain negative effect on the pregnancy rate(PR) and live birth rate(LBR) compared to Cook balloon placement for one week following operative hysteroscopy. These findings need to be further validated through high-quality studies with larger sample sizes. TRIAL REGISTRATION: Our paper was registered at PROSPERO, with the number PROSPERO 2023 CRD42023426525.