<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815968</url>
  </required_header>
  <id_info>
    <org_study_id>0008-19-WOMC</org_study_id>
    <nct_id>NCT03815968</nct_id>
  </id_info>
  <brief_title>Low Sodium Diet in Oligohydramnios Assigned for Conservative Management</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to examine whether low salt diet can increase the amniotic fluid index&#xD;
      in patients diagnosed with oligohydramnios and assigned for conservative management. A&#xD;
      randomized controlled trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few studies have addressed the changes in maternal diet as affecting the composition and&#xD;
      amount of amniotic fluid.&#xD;
&#xD;
      Some articles have shown an increase in amniotic fluid volume as a result of maternal&#xD;
      hydration during pregnancy through intravenous fluid infusions and oral fluid intake, the&#xD;
      increase was evident in women with amniotic fluid and women with normal amniotic fluid&#xD;
      volume. In a mechanism similar to that of liquid hydration, a low-salt diet may lead to an&#xD;
      increase in the volume of amniotic fluid.&#xD;
&#xD;
      The investigators would like to examine whether a low-salt diet in women with amniotic fluid&#xD;
      is able to significantly increase the amount of amniotic fluid compared with a regular diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>amniotic fluid volume, assessed by ultrasound</measure>
    <time_frame>two weeks</time_frame>
    <description>amniotic fluid volume after two weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>gestational age at birth</measure>
    <time_frame>up to 18 weeks (until delivery)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>induction of labor</measure>
    <time_frame>up to 18 weeks (until delivery)</time_frame>
    <description>The percentage of pregnant women who underwent birth induction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>labor type</measure>
    <time_frame>up to 18 weeks (until delivery)</time_frame>
    <description>Cesarean section, vaginal birth or vaginal birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy and childbirth complications</measure>
    <time_frame>up to 18 weeks (until delivery)</time_frame>
    <description>obstetrics complications and neonatal complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Oligohydramnios</condition>
  <arm_group>
    <arm_group_label>low sodium diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>regular diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>women diagnosed with oligohydramnios designated for conservative management applying a regular diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low sodium diet</intervention_name>
    <description>included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.</description>
    <arm_group_label>low sodium diet</arm_group_label>
    <other_name>low salt diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women between 24-37 weeks of gestation, single fetus, who were diagnosed with&#xD;
             an amniotic fluid index at the 5th percentile or below, according to the current&#xD;
             gestational age&#xD;
&#xD;
          -  No medical indication for immediate delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  A medical recommendation for delivery within two weeks of diagnosis&#xD;
&#xD;
          -  Fetal malformation or proof of fetal infection that known to cause oligohydramnios (eg&#xD;
             CMV).&#xD;
&#xD;
          -  Premature rupture of membrane&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Medical contraindication to the low-salt diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michal Levy, MD</last_name>
    <phone>0528591994</phone>
    <email>levmichal@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eran Weiner, MD</last_name>
    <email>eranweiner.md@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Departments of Obstetrics &amp; Gynecology, affiliated with Sackler Faculty of Medicine, Tel Aviv University</name>
      <address>
        <city>H̱olon</city>
        <zip>6404519</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>27062200</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>11441685</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>1732479</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>16140901</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>7485317</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>9764623</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17623581</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>23726817</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>14456322</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>2187347</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Michal Levy, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>oligohydroamnios</keyword>
  <keyword>low salt diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oligohydramnios</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815968
org study id: 0008-19-WOMC
nct id: NCT03815968
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
Few studies have addressed the changes in maternal diet as affecting the composition and
      amount of amniotic fluid.

      Some 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.

      The 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: amniotic fluid volume, assessed by ultrasound
time frame: two weeks
description: amniotic fluid volume after two weeks
measure: gestational age at birth
time frame: up to 18 weeks (until delivery)
measure: induction of labor
time frame: up to 18 weeks (until delivery)
description: The percentage of pregnant women who underwent birth induction
measure: labor type
time frame: up to 18 weeks (until delivery)
description: Cesarean section, vaginal birth or vaginal birth
measure: Pregnancy and childbirth complications
time frame: up to 18 weeks (until delivery)
description: obstetrics complications and neonatal complications
arm group label: low sodium diet
arm group type: Experimental
description: women diagnosed with oligohydramnios designated for conservative management applying a low-salt diet.
arm group label: regular diet
arm group type: No Intervention
description: women diagnosed with oligohydramnios designated for conservative management applying a regular diet.
intervention type: Other
intervention name: low sodium diet
description: included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.
arm group label: low sodium diet
other name: low salt diet
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michal Levy, MD
phone: 0528591994
email: levmichal@gmail.com
last name: Eran Weiner, MD
email: eranweiner.md@gmail.com
facility: 
country: Israel
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: 27062200
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: 11441685
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: 1732479
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: 16140901
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: 7485317
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: 9764623
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: 17623581
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: 23726817
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: 14456322
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.
PMID: 2187347
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Michal Levy, MD
investigator title: Principal Investigator
mesh term: Oligohydramnios
sharing ipd: No