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Calcium Channel Blockers Compared to Magnesium Sulfate in Fetal Cerebral Blood Flow

NCT02591004 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2017-11-17

No results posted yet for this study

Summary

The aim of this study is to investigate the possible use of calcium channel as a neuroprotectant in cases with PTL. This will be done by comparing the effect they have on cerebral blood vessels with the already established MgSo4. They have been proven superior to magnesium sulphate in tocolysis, and they possess the mechanism of action that would allow for their theoretical use as neuroprotective agents.

Conditions

  • Preterm Labor
  • Cerebral Palsy

Interventions

DRUG

Magesium sulphate

\*Experimental: Group A: Magesium sulphate 4 gm intravenous (I.V) loading dose over 30 mins \& 1 gm/ hour maintenance dose for 24 hours, or till labor occurs ( whichever occurs first)

DRUG

Nifedipine

\*Active Comparator: Group B Nifedipine wil be given in a loading dose of 40 mg in the 1st hour (10mg will be given every 15 min), then a maintenance dose of 60mg /24 hours, divided in 3 doses

RADIATION

Doppler on fetal middle cerebral artery

both group A and group B: ultrasound doppler to measure the mean pulsility index (PI) and resistance index (PI) of the middle cerebral artery in the fetus twice, once before giving them the drug, and the other after 4 hours of starting the loading dose.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Ahmed M Kamel, M.D. · Lecturer of obstetrics & Gynecology

  • Wafaa Eldesouky, M.D. · Lecturer of obstetrics & Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-10-31
Completion
2017-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591004 on ClinicalTrials.gov