NCT02506894

Brief Summary

Two groups of women with preterm labor will be included. One will receive magnesium sulfate for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2015

Shorter than P25 for early_phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

July 21, 2015

Last Update Submit

January 29, 2016

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • changes in fetal middle cerebral artery Doppler indices

    3 months

Secondary Outcomes (1)

  • maternal adverse effects of magnesium sulfate

    3 months

Study Arms (2)

magnesium sulfate

ACTIVE COMPARATOR

this group will receive magnesium sulfate loading dose 6 g in 500 cc of ringer solution over 20 minutes then maintenance dose of 1 g/ hour for 24 hours.

Drug: Magnesium Sulfate

placebo group

PLACEBO COMPARATOR

this group will receive sodium chloride 0.9% solution for 24 hours.

Other: 0.9% sodium chloride solution

Interventions

Magnesium SulfateDRUG

magnesium sulfate will be given for 24 hours

Also known as: MgSO4
magnesium sulfate
0.9% sodium chloride solutionOTHER

normal saline will be given as intravenous drip over 24 hours

placebo group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women with preterm labor
  • gestational age less than 32 weeks
  • singleton pregnancy

You may not qualify if:

  • contraindication or hypersensitivity to magnesium
  • preeclampsia
  • multiple pregnancy
  • intake of magnesium sulfate in this pregnancy before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Magnesium SulfateSodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Ghada Abdel Fattah Abdel Moety, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

EG(1)