Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506894

Enrollment

Registered

2015-07-23

Start date

2015-07-31

Completion date

2015-11-30

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

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.

Detailed description

The study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices \[Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)\] will be recorded before and after treatment in both groups. Results of Doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.

Interventions

DRUGMagnesium Sulfate

magnesium sulfate will be given for 24 hours

OTHER0.9% sodium chloride solution

normal saline will be given as intravenous drip over 24 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
changes in fetal middle cerebral artery Doppler indices	3 months

Secondary

Measure	Time frame
maternal adverse effects of magnesium sulfate	3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026