Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT02363569
Status:
UNKNOWN
Last Update Posted:
2015-02-16
First Post:
2015-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognosis of Early Pregnancy With Post Coital Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-13', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Complications (abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension)', 'timeFrame': 'after they give birth (8 month after they address to the E.R.)', 'description': 'abortion, pre eclampsia, pre term labor,, cervix shortening, gestational diabetes, placental abruption, P-PROM(pre mature rupture of membrane), intrauterine growth retardation , Hypertension'}, {'measure': 'Delivery Complications (cesarean section,assisted delivery)', 'timeFrame': 'after they give birth (8 month after they address to the E.R.)', 'description': 'cesarean section,assisted delivery.'}, {'measure': 'Newborn Complications (low apgar, small gestational age , need for blood transfusion, artificial respiration, infection)', 'timeFrame': 'after they give birth (8 month after they address to the E.R.)', 'description': 'low apgar, small gestational age , need for blood transfusion, artificial respiration, infection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post coital bleeding', 'vaginal bleeding'], 'conditions': ['Vaginal Bleeding During Pregnancy', 'Postcoital Bleeding']}, 'referencesModule': {'references': [{'pmid': '9233324', 'type': 'BACKGROUND', 'citation': 'Everett C. Incidence and outcome of bleeding before the 20th week of pregnancy: prospective study from general practice. BMJ. 1997 Jul 5;315(7099):32-4. doi: 10.1136/bmj.315.7099.32.'}, {'pmid': '13162785', 'type': 'BACKGROUND', 'citation': 'SPEERT H, GUTTMACHER AF. Frequency and significance of bleeding in early pregnancy. J Am Med Assoc. 1954 Jun 19;155(8):712-5. doi: 10.1001/jama.1954.03690260004002. No abstract available.'}, {'pmid': '11212982', 'type': 'BACKGROUND', 'citation': 'Rosenthal AN, Panoskaltsis T, Smith T, Soutter WP. The frequency of significant pathology in women attending a general gynaecological service for postcoital bleeding. BJOG. 2001 Jan;108(1):103-6. doi: 10.1111/j.1471-0528.2001.00008.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women- E.R." at "Meir" Hospital due to spontaneous -or after intercourse- bleeding or bleeding secretions. The women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy). After they give birth the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups.', 'detailedDescription': 'This is a prospective study, where the investigators will monitor pregnant women at 4-23 weeks of pregnancy coming to the "Women E.R" at "Meir" Hospital due to spontaneous -or after intercourse bleeding - bleeding secretions. The women will be divided in to two groups\n\n1. Pregnant women (age 18-40) at 4-23 weeks of pregnancy with spontaneous bleeding or bleeding secretions\n2. Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse.\n\nThe women will fill out questionnaires regarding past illness, vaginal bleeding, and gynecologic history. Then they will undergo full examination including ultrasound. After discharge, the investigators will recommend to all the women who came due to bleeding or bleeding secretions to avoid intercourse for two weeks after the bleeding stops. Afterwards they will be monitored until their delivery date (filling questionnaires a month after coming to the E.R. and at the end of the pregnancy) The doctor that had examined the women, will have to fill out questionnaires regarding the bleeding source, the time after intercourse, how long after the intercourse the bleeding had appeared and which kind of examination he had carried out.\n\nA month after their appeal to the E.R. and after they give birth ,the investigators will assess the rate of pregnancy, obstetric and embryonic complications in each of the study groups, by phone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with early pregnancy (4-23 weeks) with singletons or twins that address to the "Women E.R." due to vaginal bleeding.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women (age 18-40) with early pregnancy (4-23 weeks) with singleton or twins pregnancy that address to the "Women E.R." due to vaginal bleeding.\n\nExclusion Criteria:\n\n* age \\>40 or \\<18\n* women with history of more then 3 abortions.\n* women with history of more then 2 pre term labor\n* ectopic pregnancy\n* placental previa\n* women who takes anticoagulation therapy\n* women with known pathology at cervix.\n* women with known uterus defect. pregnancies with chromosomal defects or birth defects that was discovered at the screening tests.'}, 'identificationModule': {'nctId': 'NCT02363569', 'briefTitle': 'The Prognosis of Early Pregnancy With Post Coital Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Prognosis of Early Pregnancy With Post Coital Bleeding Compared to Early Pregnancy With Spontaneous Bleeding', 'orgStudyIdInfo': {'id': 'MeirMc 180-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case-', 'description': 'Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed to the "Women ER" 24 hours after bleeding or bleeding secretions due to intercourse.'}, {'label': 'control', 'description': 'Pregnant women (age 18-40) at 4-23 weeks of pregnancy that have appealed the "women ER" due to spontaneous bleeding or bleeding secretions'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'state': 'Israel', 'country': 'Israel', 'facility': 'Meir Hospital', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'Meir Pomeranz, M.D', 'role': 'CONTACT', 'email': 'Pomeranzmiki@clalit.org.il', 'phone': '+972537482770'}, {'name': 'Danit Aviv', 'role': 'CONTACT', 'email': 'danith1@walla.co.il', 'phone': '+97254967060'}], 'overallOfficials': [{'name': 'Meir Pomeranz, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Hospital, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}