Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT03081104
Status:
UNKNOWN
Last Update Posted:
2017-04-11
First Post:
2017-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-08', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate after evacuation', 'timeFrame': '12 months after procedure', 'description': 'duration needed to achieve pregnancy after evacuation provided non use of contraceptive methods'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Missed Abortion']}, 'referencesModule': {'references': [{'pmid': '35614405', 'type': 'DERIVED', 'citation': 'Meshaal H, Salah E, Fawzy E, Abdel-Rasheed M, Maged A, Saad H. Hysteroscopic management versus ultrasound-guided evacuation for women with first-trimester pregnancy loss, a randomised controlled trial. BMC Womens Health. 2022 May 25;22(1):190. doi: 10.1186/s12905-022-01774-2.'}]}, 'descriptionModule': {'briefSummary': "The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided aspiration(group C) and blinded vacuum aspiration(group B).\n\nFor 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.\n\nGroup A: Operative Hystroscopy:\n\nThe 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. .\n\nGroup B:blinded vacuum aspiration of gestational contents:\n\nThe 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.\n\nGroup C: Ultrasound guided aspiration curettage :\n\nsame as group B but guided with ultrasound", 'detailedDescription': "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.\n\nGroup A: Operative Hystroscopy:\n\nThe 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.\n\nGroup B:blinded vacuum aspiration of gestational contents:\n\nThe 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.\n\nGroup C: Ultrasound guided aspiration curettage :\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Women in the fertility perioddiagnosed with missed abortion in the first trimester \\< 14 wks of gestation.\n\nThe pregnancy concerned should correspond to a planned or wanted baby. Diagnosis of missed abortion by transvaginal ultrasound showing sgestational sac with no cardiac pulsations.\n\nExclusion Criteria:\n\n* • Other type of abortion.\n\n * Known uterine malformation.\n * History of surgical intervention done in the uterus or uterine cavity.\n * Moderate to sever vaginal bleeding needing rapid surgical intervention.\n * Presence of IUD\n * Current pregnancy obtained by IVF cycle\n * Extrauterine pregnancy'}, 'identificationModule': {'nctId': 'NCT03081104', 'briefTitle': 'Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Operative Hysteroscopy Versus the Ultrasound Guided Vacuum Aspiration Versus the Blind Vacuum Aspiration for the Treatment of the Missed Abortion', 'orgStudyIdInfo': {'id': '161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hystroscopy', 'description': '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.', 'interventionNames': ['Device: hystroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound guided aspiration', 'description': '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.', 'interventionNames': ['Device: ultrasound', 'Procedure: Aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'blind aspiration', 'description': "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.", 'interventionNames': ['Procedure: Aspiration']}], 'interventions': [{'name': 'hystroscopy', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['hystroscopy']}, {'name': 'ultrasound', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['ultrasound guided aspiration']}, {'name': 'Aspiration', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['blind aspiration', 'ultrasound guided aspiration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}], 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}, {'name': 'Hany Saad, MD', 'role': 'CONTACT', 'email': 'hanysaad25280@gmail.com'}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}