Missed Abortion Clinical Trial
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
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
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.
Group C: Ultrasound guided aspiration curettage :
The transducer was held on the abdomen to obtain a longitudinal image of the uterus and
cervix and provide the surgeon with a visual reference of the gestational sac, cervical
canal and any instruments passed into the uterus.The progress of the operation was
continuously monitored as the uterine contents were evacuated under visual control. It was
possible to keep the dilators and the suction cannula under constant view by slightly
tilting the transducer as required. Advancement of any instrument was allowed only under
direct ultrasound control.The completeness of the evacuation was confirmed by the scan in
these cases.
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