Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-03-08 @ 5:56 AM
Study NCT ID:
NCT03815968
Status:
UNKNOWN
Last Update Posted:
2019-01-25
First Post:
2019-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Sodium Diet in Oligohydramnios Assigned for Conservative Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016104', 'term': 'Oligohydramnios'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amniotic fluid volume, assessed by ultrasound', 'timeFrame': 'two weeks', 'description': 'amniotic fluid volume after two weeks'}], 'secondaryOutcomes': [{'measure': 'gestational age at birth', 'timeFrame': 'up to 18 weeks (until delivery)'}, {'measure': 'induction of labor', 'timeFrame': 'up to 18 weeks (until delivery)', 'description': 'The percentage of pregnant women who underwent birth induction'}, {'measure': 'labor type', 'timeFrame': 'up to 18 weeks (until delivery)', 'description': 'Cesarean section, vaginal birth or vaginal birth'}, {'measure': 'Pregnancy and childbirth complications', 'timeFrame': 'up to 18 weeks (until delivery)', 'description': 'obstetrics complications and neonatal complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oligohydroamnios', 'low salt diet'], 'conditions': ['Oligohydramnios']}, 'referencesModule': {'references': [{'pmid': '27062200', 'type': 'RESULT', 'citation': 'Rabie N, Magann E, Steelman S, Ounpraseuth S. Oligohydramnios in complicated and uncomplicated pregnancy: a systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2017 Apr;49(4):442-449. doi: 10.1002/uog.15929.'}, {'pmid': '11441685', 'type': 'RESULT', 'citation': 'Rainford M, Adair R, Scialli AR, Ghidini A, Spong CY. Amniotic fluid index in the uncomplicated term pregnancy. Prediction of outcome. J Reprod Med. 2001 Jun;46(6):589-92.'}, {'pmid': '1732479', 'type': 'RESULT', 'citation': 'Koski KG, Fergusson MA. Amniotic fluid composition responds to changes in maternal dietary carbohydrate and is related to metabolic status in term fetal rats. J Nutr. 1992 Feb;122(2):385-92. doi: 10.1093/jn/122.2.385.'}, {'pmid': '16140901', 'type': 'RESULT', 'citation': 'Gurekian CN, Koski KG. Amniotic fluid amino acid concentrations are modified by maternal dietary glucose, gestational age, and fetal growth in rats. J Nutr. 2005 Sep;135(9):2219-24. doi: 10.1093/jn/135.9.2219.'}, {'pmid': '7485317', 'type': 'RESULT', 'citation': 'Flack NJ, Sepulveda W, Bower S, Fisk NM. Acute maternal hydration in third-trimester oligohydramnios: effects on amniotic fluid volume, uteroplacental perfusion, and fetal blood flow and urine output. Am J Obstet Gynecol. 1995 Oct;173(4):1186-91. doi: 10.1016/0002-9378(95)91350-5.'}, {'pmid': '9764623', 'type': 'RESULT', 'citation': 'Doi S, Osada H, Seki K, Sekiya S. Effect of maternal hydration on oligohydramnios: a comparison of three volume expansion methods. Obstet Gynecol. 1998 Oct;92(4 Pt 1):525-9. doi: 10.1016/s0029-7844(98)00242-7.'}, {'pmid': '17623581', 'type': 'RESULT', 'citation': 'Umber A, Chohan MA. Intravenous maternal hydration in third trimester oligohydramnios: effect on amniotic fluid volume. J Coll Physicians Surg Pak. 2007 Jun;17(6):336-9.'}, {'pmid': '23726817', 'type': 'RESULT', 'citation': 'Rakova N, Muller DN, Staff AC, Luft FC, Dechend R. Novel ideas about salt, blood pressure, and pregnancy. J Reprod Immunol. 2014 Mar;101-102:135-139. doi: 10.1016/j.jri.2013.04.001. Epub 2013 May 30.'}, {'pmid': '14456322', 'type': 'RESULT', 'citation': 'Kirksey A, Pike RL, Callahan JA. Some effects of high and low sodium intakes during pregnancy in the rat. II. Electrolyte concentrations of maternal plasma, muscle, bone and brain and of placenta, amniotic fluid, fetal plasma and total fetus in normal pregnancy. J Nutr. 1962 May;77(1):43-51. doi: 10.1093/jn/77.1.43. No abstract available.'}, {'pmid': '2187347', 'type': 'RESULT', 'citation': 'Moore TR, Cayle JE. The amniotic fluid index in normal human pregnancy. Am J Obstet Gynecol. 1990 May;162(5):1168-73. doi: 10.1016/0002-9378(90)90009-v.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to examine whether low salt diet can increase the amniotic fluid index in patients diagnosed with oligohydramnios and assigned for conservative management. A randomized controlled trial', 'detailedDescription': 'Few studies have addressed the changes in maternal diet as affecting the composition and amount of amniotic fluid.\n\nSome articles have shown an increase in amniotic fluid volume as a result of maternal hydration during pregnancy through intravenous fluid infusions and oral fluid intake, the increase was evident in women with amniotic fluid and women with normal amniotic fluid volume. In a mechanism similar to that of liquid hydration, a low-salt diet may lead to an increase in the volume of amniotic fluid.\n\nThe investigators would like to examine whether a low-salt diet in women with amniotic fluid is able to significantly increase the amount of amniotic fluid compared with a regular diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 24-37 weeks of gestation, single fetus, who were diagnosed with an amniotic fluid index at the 5th percentile or below, according to the current gestational age\n* No medical indication for immediate delivery\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* A medical recommendation for delivery within two weeks of diagnosis\n* Fetal malformation or proof of fetal infection that known to cause oligohydramnios (eg CMV).\n* Premature rupture of membrane\n* Multiple pregnancy\n* Medical contraindication to the low-salt diet'}, 'identificationModule': {'nctId': 'NCT03815968', 'briefTitle': 'Low Sodium Diet in Oligohydramnios Assigned for Conservative Management', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'The Influence of Low Sodium Diet on an Amniotic Fluid Index in a Patient That Diagnosed With Oligohydramnios and Assigned for Conservative Management - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0008-19-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low sodium diet', 'description': 'women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.', 'interventionNames': ['Other: low sodium diet']}, {'type': 'NO_INTERVENTION', 'label': 'regular diet', 'description': 'women diagnosed with oligohydramnios designated for conservative management applying a regular diet.'}], 'interventions': [{'name': 'low sodium diet', 'type': 'OTHER', 'otherNames': ['low salt diet'], 'description': 'included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.', 'armGroupLabels': ['low sodium diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6404519', 'city': 'Holon', 'country': 'Israel', 'facility': 'Departments of Obstetrics & Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'Michal Levy, MD', 'role': 'CONTACT', 'email': 'levmichal@gmail.com', 'phone': '0528591994'}, {'name': 'Eran Weiner, MD', 'role': 'CONTACT', 'email': 'eranweiner.md@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michal Levy, MD', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}