NCT05332015

Brief Summary

OBJECTIVE: The primary objective of our study is to compare the effects of routine hydration with additional 2 liters of normal water versus orally 2 liters of distilled water on the amount of amniotic fluid. HYPOTHESIS: İsolated oligohydramnios, secondary to depleted maternal intravascular volume, can be reversed better with orally hypotonic water.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

March 31, 2022

Last Update Submit

January 31, 2023

Conditions

Oligohydramnios

Keywords

OligohydramniosHydrotherapyHypotonic hydrotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Reversal of Oligohydramnios Using AFV Measures

    The change between the basal amniotic fluid index and the value on day 7

    admission, day 7

Study Arms (2)

Oral hydration with normal water

ACTIVE COMPARATOR

Oral hydration with drinkable normal water daily additional 2 liters for 5 days

Other: Hypotonic (distilled) water

Oral hydration with distilled water

ACTIVE COMPARATOR

Oral hydration with distilled water daily 2 liters for 5 days

Other: Normal water

Interventions

Hypotonic (distilled) waterOTHER

orally given daily two liters of distilled water

Oral hydration with normal water
Normal waterOTHER

orally given daily two liters of normal water

Oral hydration with distilled water

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy
  • Gestational age (GA) 28-39 weeks (based on the last menstrual period and confirmed by the results of ultrasound or determined through early pregnancy sonography)
  • Isolated oligohydramnios cases
  • Amniotic fluid index ≤ 5
  • No pregnancy complications such as preeclampsia, gestational hypertension
  • Intact fetal membranes.

You may not qualify if:

  • Presence of fetal complications (membrane rupture, presence of fetal anomaly, intrauterine growth restriction)
  • Presence of maternal systemic disease (nephropathy, cardiac disease)
  • Multiple pregnancies
  • Conditions in which the amount of amniotic fluid cannot be accurately assessed (morbid obesity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07100, Turkey (Türkiye)

Location

Related Publications (2)

  • Gizzo S, Noventa M, Vitagliano A, Dall'Asta A, D'Antona D, Aldrich CJ, Quaranta M, Frusca T, Patrelli TS. An Update on Maternal Hydration Strategies for Amniotic Fluid Improvement in Isolated Oligohydramnios and Normohydramnios: Evidence from a Systematic Review of Literature and Meta-Analysis. PLoS One. 2015 Dec 11;10(12):e0144334. doi: 10.1371/journal.pone.0144334. eCollection 2015.

    PMID: 26658482BACKGROUND

  • Kilpatrick SJ, Safford KL, Pomeroy T, Hoedt L, Scheerer L, Laros RK. Maternal hydration increases amniotic fluid index. Obstet Gynecol. 1991 Dec;78(6):1098-102.

    PMID: 1945215BACKGROUND

MeSH Terms

Conditions

Oligohydramnios

Interventions

Water

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 18, 2022

Study Start

April 28, 2022

Primary Completion

June 28, 2022

Study Completion

August 28, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)