NCT02591004

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2015

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

First Submitted

Initial submission to the registry

October 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

October 26, 2015

Last Update Submit

November 15, 2017

Conditions

Preterm LaborCerebral Palsy

Keywords

Neuroprotectioncalcium channel blockersmagnesium sulhateMiddle cerebral artery doppler

Outcome Measures

Primary Outcomes (1)

  • difference in mean doppler indicies of middle cerebral artery of fetus between both groups

    4 hours

Study Arms (2)

Magesium sulphate

EXPERIMENTAL

* Patients in group A will receive 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). * Doppler on fetal middle cerebral artery

Drug: Magesium sulphateRadiation: Doppler on fetal middle cerebral artery

Nifedipine

ACTIVE COMPARATOR

* Patients in group B will receive Nifedipine ( Epilat 10mg ® EIPICO Egypt ), as there is no recommended dose for the use of nifedipine as neuroprotectant, the dose given in this study will be same as that used for tocolysis. 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. * Doppler on fetal middle cerebral artery

Drug: NifedipineRadiation: Doppler on fetal middle cerebral artery

Interventions

Magesium sulphateDRUG

\*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)

Also known as: MgSo4
Magesium sulphate
NifedipineDRUG

\*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

Also known as: Epilat
Nifedipine
Doppler on fetal middle cerebral arteryRADIATION

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.

Magesium sulphateNifedipine

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • in imminent preterm labour ( , \>4cm dilated, cervical effacement \> 60%).
  • \< 32 weeks gestational age.

You may not qualify if:

  • patients will be excluded from the study if the gestational age was \> 32 weeks
  • intrauterine fetal death
  • multiple gestation
  • fetal malformations where only palliative care is needed
  • placental abruption
  • Chorioamnionitis
  • pre-ecplamsia, or diabetes
  • suspected fetal compromise diagnosed by ultrasound or CTG requiring delivery, -any indication for caesarean section
  • fetal growth restriction
  • Also any contraindication to the use of Nifedipine e.g maternal cardiac disease, allergy to Nifedipine, hypotension, or hepatic dysfunction
  • Contraindications To MgSo4 use as Myasthenia Gravis, progressive muscle weakness ,allergy to MgSo4, severe renal impairment \& heart block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11562

Cairo, 11562, Egypt

Location

Related Publications (5)

  • Magee L, Sawchuck D, Synnes A, von Dadelszen P; MAGNESIUM SULPHATE FOR FETAL NEUROPROTECTION CONSENSUS COMMITTEE; MATERNAL FETAL MEDICINE COMMITTEE. SOGC Clinical Practice Guideline. Magnesium sulphate for fetal neuroprotection. J Obstet Gynaecol Can. 2011 May;33(5):516-529. doi: 10.1016/S1701-2163(16)34886-1.

    PMID: 21639972BACKGROUND

  • Hosli I, Sperschneider C, Drack G, Zimmermann R, Surbek D, Irion O; Swiss Society of Obstetrics and Gynecology. Tocolysis for preterm labor: expert opinion. Arch Gynecol Obstet. 2014 Apr;289(4):903-9. doi: 10.1007/s00404-013-3137-9. Epub 2014 Jan 3.

    PMID: 24385286BACKGROUND

  • Australian Research Centre for Health of Women and Babies. Antenatal Magnesium Sulphate Prior to Preterm Birth for Neuroprotection of the Fetus, Infant and Child - National Clinical Practice Guidelines. Adelaide. ARCH; 2010 [www.adelaide.edu.au/arch/].

    BACKGROUND

  • Macdonald RL, Curry DJ, Aihara Y, Zhang ZD, Jahromi BS, Yassari R. Magnesium and experimental vasospasm. J Neurosurg. 2004 Jan;100(1):106-10. doi: 10.3171/jns.2004.100.1.0106.

    PMID: 14743919BACKGROUND

  • Grether J, Hirtz D, McNellis D, Nelson K, Rouse DJ. Tocolytic magnesium sulphate and paediatric mortality. Lancet. 1998 Jan 24;351(9098):292; author reply 293. doi: 10.1016/S0140-6736(05)78239-8. No abstract available.

    PMID: 9457123BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, PrematureCerebral Palsy

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ahmed M Kamel, M.D.

    Lecturer of obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

  • Wafaa Eldesouky, M.D.

    Lecturer of obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics & Gynecology

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 29, 2015

Study Start

December 1, 2015

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

EG(1)