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宫腔镜子宫纵隔切除术加与不加宫内球囊支架置入后的生育力和妊娠结局:一项随机试验研究

Fertility and pregnancy outcomes following resectoscopic septum division with and without intrauterine balloon stenting: a randomized pilot study.

作者信息

Abu Rafea Basim Fouad, Vilos George Angelos, Oraif Ayman Mohamad, Power Stephen George, Cains Jackie Hollet, Vilos Angelos George

机构信息

Obstetrics and Gynecology Department, King Saud University, Riyadh, Saudi Arabia.

出版信息

Ann Saudi Med. 2013 Jan-Feb;33(1):34-9. doi: 10.5144/0256-4947.2013.34.

Abstract

BACKGROUND AND OBJECTIVES

Although uterine stenting is performed routinely following hysteroscopic metroplasty, we were unable to find any evidence documenting its value with regards to septum reformation and/or obstetrical performance. To evaluate the benefits of intrauterine Foley catheter/balloon splinting after resectoscopic septum division on septum reformation, fertility, and pregnancy outcomes.

DESIGN AND SETTING

Prospective, randomized controlled pilot study (Canadian Task Force Classification I) conducted in university affiliated teaching hospital.

PATIENTS AND METHODS

Twenty-eight women with infertility and/or adverse pregnancy outcomes diagnosed with intrauterine septum were randomized into having a No. 14 pediatric Foley catheter/balloon for 5 days (n=13) vs. no balloon (n=15) following resectoscopic septum division. None of the patients received preoperative endometrial thinning, antibiotic prophylaxis or adjuvant postoperative hormone therapy. All uterine septa were divided under general anaesthesia using a 26 F (9 mm) resectoscope with a monopolar electrical knife using glycine irrigant solution (1.5%) and 120 watts of power of low voltage (cut) waveform.

RESULTS

The median age (range) was 29 years (23-38) and 32 years (22-40), respectively (P=.59). The groups were comparable by age, past obstetrical performance and comorbidities including endometriosis stage I-IV in 3 and 4 women, in the catheter/balloon and balloon group, respectively, and one in each group of polycystic ovarian syndrome and Crohn disease and one case of tubal obstruction in the balloon group. There were no intra- or postoperative complications. At 3 months, a hysterosalpingogram was done in 10 (77%) and 13 (87%) women, respectively, the results of which were normal. At 12-18 months, 1 woman in the balloon and 3 in the control group were not trying to conceive and 1 in each group had not conceived. Of the remaining women, 11 (92%) in each group had conceived and pregnancy outcomes included spontaneous abortion 3 (25%) and 4 (33.3%), ectopic pregnancy 0 and 1, second trimester loss 1 (8.3%) and 0 and term pregnancy 8 (66.6%) in both groups. Conception through assisted reproductive technology occurred in 2 and 1 woman, respectively.

CONCLUSIONS

Following resectoscopic septum division with monopolar knife electrode, splinting the uterine cavity with Foley catheter provided no advantage in septum reformation, clinical pregnancy rate, and pregnancy outcomes.

摘要

背景与目的

尽管宫腔镜子宫成形术后常规进行子宫支架置入,但我们未能找到任何证据证明其在中隔重塑和/或产科结局方面的价值。旨在评估经宫腔镜中隔切开术后使用宫内Foley导管/球囊支撑对中隔重塑、生育能力和妊娠结局的益处。

设计与地点

在大学附属医院进行的前瞻性、随机对照试验研究(加拿大工作组分类I级)。

患者与方法

28例诊断为子宫中隔且有不孕和/或不良妊娠结局的女性,在经宫腔镜中隔切开术后,随机分为两组,一组置入14号小儿Foley导管/球囊并保留5天(n = 13),另一组不放置球囊(n = 15)。所有患者均未接受术前子宫内膜减薄、抗生素预防或术后辅助激素治疗。所有子宫中隔均在全身麻醉下,使用带有单极电刀的26F(9mm)宫腔镜,采用1.5%的甘氨酸灌洗液和120瓦低电压(切割)波形功率进行切开。

结果

两组患者的中位年龄(范围)分别为29岁(23 - 38岁)和32岁(22 - 40岁)(P = 0.59)。两组在年龄、既往产科情况和合并症方面具有可比性,导管/球囊组和无球囊组分别有3例和4例子宫内膜异位症I - IV期患者,每组各有1例多囊卵巢综合征、克罗恩病患者,无球囊组有1例输卵管阻塞患者。术中及术后均无并发症发生。3个月时,分别有10例(77%)和13例(87%)女性进行了子宫输卵管造影,结果均正常。12 - 18个月时,球囊组有1名女性、对照组有3名女性未尝试受孕,每组各有1名女性未受孕。在其余女性中,两组各有11例(92%)受孕,妊娠结局包括自然流产,两组分别为3例(25%)和4例(33.3%);异位妊娠,两组分别为0例和1例;孕中期流产,两组分别为1例(8.3%)和0例;足月妊娠,两组均为8例(66.6%)。两组分别有2例和1例通过辅助生殖技术受孕。

结论

在使用单极刀电极经宫腔镜切开子宫中隔后,用Foley导管支撑子宫腔在中隔重塑、临床妊娠率和妊娠结局方面并无优势。

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