Clinical Trial: Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Comparative Study Between Operative Hysteroscopy Versus the Ultrasound Guided Vacuum Aspiration Versus the Blind Vacuum Aspiration for the Treatment of the Missed Abortion
Brief Summary:
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 evacuatio
Detailed Summary:
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'
Sponsor: Cairo University
Current Primary Outcome: pregnancy rate after evacuation [ Time Frame: 12 months after procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Cairo University
Dates:
Date Received: March 10, 2017
Date Started: March 31, 2017
Date Completion: December 2017
Last Updated: April 8, 2017
Last Verified: April 2017
