Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-30 @ 11:17 PM
Study NCT ID:
NCT05024604
Status:
UNKNOWN
Last Update Posted:
2021-08-27
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-21', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-21', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary outcome', 'timeFrame': 'an average of 1 year', 'description': 'Hysteroscopic findings in women using POPs versus those not using hormones.( cervical mucosa , endometrium )'}], 'secondaryOutcomes': [{'measure': 'subsidiary', 'timeFrame': 'an average of 1 year', 'description': 'documentation of the local effects of POPs as a method of contraception'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Women Health', 'Contraception']}, 'descriptionModule': {'briefSummary': 'Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study.', 'detailedDescription': "Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study. versus women not using any hormonal therapy ,Office hysteroscopy would be conducted outside of the formal operating theater setting in an appropriately sized, equipped, and staffed treatment room with adjoining, private changing facilities and toilet. As the patient is aware of everything that is going on, it is advisable to organize a relaxed setting, using a protected space with a comfortable seat, Uterine distension:\n\nWhen performing diagnostic hysteroscopic procedures, it is best if a non-viscous, physiologic solution is used i.e. Saline or Lactated Ringers as opposed to CO2 gas. CO2 is commonly used for diagnostic hysteroscopy but is difficult to use in the presence of blood or mucous. Adequate distention pressures (50-70 mmHG) can be achieved in the office by the use of gravity or a pressure bags. Most office based procedures are of short duration and no more than 2 liters of solution should be utilized. In this situation, it is not necessary to monitor fluid inflow, outflow and deficits in the office setting. The standard access approach to the cervix involves placing a speculum within the vagina (preferably side opening), placing single tenaculum on the anterior lip of the cervix, injecting the cervix with local anaesthesia (if necessary), and placing the rigid continuous flow hysteroscope within the cervical canal. In most patients, including nulliparous and post menopausal patients, it is not necessary to dilate the cervix prior to insertion. Once the hysteroscope is within the cervical canal, the speculum should be removed, the fluid flow is begun and the hysteroscope is advanced through the cervical canal and into the uterine cavity under direct visualization.\n\nThe endometrium will be inspected by outpatient hysteroscopy The following observations made at hysteroscopy, and reviewed in detail from the video record of the examination Glandular and stromal changes The color, thickness, texture and regularity of the endometrial stroma would be assessed during hysteroscopy Superficial vascular density Endometrial vascular density would be assessed at hysteroscopy by direct inspection of the blood vessels, and graded according to the abundance of superficial vessels observed. Superficial vascular density would be reassessed after uterine collapse and Re distention.\n\nVascular morphology The shape and configuration of superficial and deep endometrial vessels would be assessed at hysteroscopy. The presence of regular and irregular (neo vascular and mosaic) vascular patterns in superficial and deep vessels would be recorded and graded. The presence of petechiae and ecchymosis would be recorded.\n\nAll the above values were regraded after collapse and re distention of the uterus, provided that a clear view of the endometrium could be obtained.\n\nVascular distribution The distribution of superficial and deep vasculature in the endometrium would be inspected and graded as even' or 'patchy'.\n\nEndometrial biopsies biopsies would be taken at each hysteroscopy. A small amount of endometrial tissue was obtained under direct vision using the biopsy curette (novak curette). also a detailed comment by the examiner would be given regarding the uterine ostium of the fallopian tube \\& any changes in the cervical canal and the cervical secretions any abnormal findings or pathology would be mentioned also ."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'maternal health and family planning', 'genderDescription': 'reproducative age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* study group:\n\n * women using POP.\n * Age: reproductive age.\n * Symptoms: abnormal uterine bleeding without an organic cause.\n\n 2-Authorization to participate in the study .\n* Control group\n\n 1- women attending to office hysteroscopy clinic\n * Age: reproductive Age\n * Contraception use : none.\n * Hormonal use: none.\n * Symptoms: abnormal uterine bleeding without an organic cause. All women in both groups would be subjected to Trans Vaginal U.S before doing hysteroscopy .\n\n b. Exclusion criteria:\n* study group\n\n * Coagulopathies\n * Any contraindications to POPs as :\n* past or current breast cancer, cirrhosis, and use of anticonvulsants\n* suspected pregnancy\n* current stroke or IHD\n* severe hypertension\n\n •Any contraindications to hysteroscopy as :\n* Pelvic infection\n* Pregnancy\n* Cervical cancer\n* Heavy uterine bleeding.\n* Control group --Women using any type of hormones including COCs .'}, 'identificationModule': {'nctId': 'NCT05024604', 'briefTitle': 'Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills) Prospective Cohort Study .', 'orgStudyIdInfo': {'id': '117101333'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'women receiving mini pills as a method of contraception with symptoms not diagnosed with us', 'interventionNames': ['Drug: Progesterone Only Product in Oral Dose Form', 'Other: office hysterscopy']}, {'label': 'Control group', 'description': 'women attending to office hysteroscopy unit and not taking hormonal therapy', 'interventionNames': ['Other: office hysterscopy']}], 'interventions': [{'name': 'Progesterone Only Product in Oral Dose Form', 'type': 'DRUG', 'description': 'mini pills as a contraceptive method', 'armGroupLabels': ['study group']}, {'name': 'office hysterscopy', 'type': 'OTHER', 'description': 'office hysteroscoy', 'armGroupLabels': ['Control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Assuit', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Women health hospital , Assuit university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'samuel adel gendy, master', 'role': 'CONTACT', 'email': 'docsamueladel1994@gmail.com', 'phone': '+201270344523'}, {'name': 'atef mohamed Darwish, MD', 'role': 'CONTACT', 'email': 'Atef_darwish@yahoo.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Gendy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident of Obstetrics & Gynecology', 'investigatorFullName': 'Samuel Gendy', 'investigatorAffiliation': 'Assiut University'}}}}