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临床试验/NCT03081104
NCT03081104Unknown不适用

Comparative Study Between Operative Hysteroscopy Versus the Ultrasound Guided Vacuum Aspiration Versus the Blind Vacuum Aspiration for the Treatment of the Missed Abortion

Cairo University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
pregnancy rate after evacuation

研究概览

简要总结

The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided aspiration(group C) and blinded vacuum aspiration(group B).

For all surgical procedures , surgical antibiotics prophylaxis, misoprostol to dilate cervix, and anti adhesion barrier gel will be used. The evacuated retention products will be sent for pathological examination.

Group A: Operative Hystroscopy:

The procedure will be performed under general anaesthesia with the patient in lithotomy position. the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine, with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. .

Group B:blinded vacuum aspiration of gestational contents:

The women were allowed to empty their urinary bladder before induction of anesthesia, After positioning the patient appropriately on the operating table, bimanual pelvic examination was performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum forceps. The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The aspirate was examined to confirm the presence of products of conception. The completeness of the evacuation was checked by gentle sharp curettage and final suctioning at the end of procedure.

Group C: Ultrasound guided aspiration curettage :

same as group B but guided with ultrasound

详细描述

The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided aspiration(group C) and blinded vacuum aspiration(group B).these procedures are routinely performed in the obstetrics and gynecology department for various indications. For all surgical procedures , surgical antibiotics prophylaxis, misoprostol to dilate cervix, and anti adhesion barrier gel will be used. The evacuated retention products will be sent for pathological examination. RH negative women will receive prophylaxis to prevent RH alloimmunization.

Group A: Operative Hystroscopy:

The procedure will be performed by a gynecological surgeon, under general anaesthesia with the patient in lithotomy position. Antibiotic prophylaxis may be administered, the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine, depending on the polarity of the resection system.with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. If active bleeding occurs , elective coagulation by hystroscope is done to stop intrauterine bleeding. The deficit of distending media should be calculated at the end of procedure.

Group B:blinded vacuum aspiration of gestational contents:

The women were allowed to empty their urinary bladder before induction of anesthesia, but catheterization was not performed. After positioning the patient appropriately on the operating table, bimanual pelvic examination was performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum forceps. The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The aspirate was examined to confirm the presence of products of conception. The completeness of the evacuation was checked by gentle sharp curettage and final suctioning at the end of procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women in the fertility perioddiagnosed with missed abortion in the first trimester < 14 wks of gestation.
  • The pregnancy concerned should correspond to a planned or wanted baby. Diagnosis of missed abortion by transvaginal ultrasound showing sgestational sac with no cardiac pulsations.

排除标准

  • • Other type of abortion.
  • Known uterine malformation.
  • History of surgical intervention done in the uterus or uterine cavity.
  • Moderate to sever vaginal bleeding needing rapid surgical intervention.
  • Presence of IUD
  • Current pregnancy obtained by IVF cycle
  • Extrauterine pregnancy

结局指标

主要结局

pregnancy rate after evacuation

时间窗: 12 months after procedure

duration needed to achieve pregnancy after evacuation provided non use of contraceptive methods

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

研究点 (2)

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