Clinical Trials Logo
  1. Home
  2. Preterm Birth
  3. NCT02506894
  4. Details
NCT02506894 Clinical Trial

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

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02506894
Other study ID # Mgso4 for neuroprotection
Secondary ID
Status Completed
Phase Phase 0
First received July 21, 2015
Last updated January 29, 2016
Start date July 2015
Est. completion date November 2015

Study information
Verified date January 2016
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesium Sulfate
magnesium sulfate will be given for 24 hours
Other:
• 0.9% sodium chloride solution
normal saline will be given as intravenous drip over 24 hours

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes in fetal middle cerebral artery Doppler indices 3 months No
Secondary maternal adverse effects of magnesium sulfate 3 months Yes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Completed NCT02993744 - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone N/A
Active, not recruiting NCT02673216 - Infection and Adverse Pregnancy Outcome
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT01412931 - Protein and Ultrasound Indicators of Preterm Birth N/A
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT02606058 - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures? N/A
Terminated NCT03715530 - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women N/A
Completed NCT00422526 - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial Phase 3
Enrolling by invitation NCT04251260 - Effectiveness of Positioning in Preterm Neonates N/A
Completed NCT03668860 - India Dexamethasone and Betamethasone Phase 1
Recruiting NCT03638037 - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed NCT02225353 - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery Phase 2
Recruiting NCT03992534 - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth Phase 1
Completed NCT03144141 - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery N/A
Completed NCT05210985 - Examination of the Relationship Between Home Affordances With Development
Completed NCT04021654 - What is the Future of Vulnerable New-borns