Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion

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 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

Conditions

• Missed Abortion

Interventions

DEVICE

hystroscopy

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.

DEVICE

ultrasound

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.

PROCEDURE

Aspiration

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.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Ahmed Maged, MD · Kasr Alainy medical school

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Egypt

Study Locations