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Preterm LaborPhase 2/3NCT02591004

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

A Phase 2/3 study testing Magesium sulphate, Nifedipine and Doppler on fetal middle cerebral artery in people with Preterm Labor and Cerebral Palsy, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Labor, Cerebral Palsy
What is being tested?
Magesium sulphate, Nifedipine and Doppler on fetal middle cerebral artery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteEgypt
Study dates
Dec 2015to Nov 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • 11562

    Cairo, 11562

Other trials in Egypt

About this study

Official title: Comparing Fetal Cerebral Blood Flow Between Magnesium Sulfate & Calcium Channel Blockers in Patients With Preterm Labor; a Randomized Controlled Trial.

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.

Read the detailed description

After internal review board approval from the obstetrics and gynecology department of Kasr Alainy hospital, 130 patients will be recruited in a randomized case control study. The patients will be recruited from the emergency admissions department, after fulfilling the recruitment criteria. In an independent case-control study the Sample size was calculated using an odds ratio of exposure to CP of 0.14 (95% CI 0.05-0.51) (Grether et.al, 1998), where the alpha level error was fixed at 0.5 and the power was set at 80%, the optimal sample size was calculated to be 65 patients in each arm.

Patients will be randomized on admission by nurse in labor ward into either one of two groups. Group A will receive MgSo4, while group B will receive Nifedipine ( Epilat 20mg ® EIPICO Egypt ). Randomization will be achieved through a computer generated randomization table. Recruitment will continue till 65 patients will be allocated to each group.

Patients in group A will receive 4 gm intravenous (I.V) MgSo4 loading dose over 30 mins \& 1 gm/ hour maintenance dose for 24 hours, or till labor occurs ( whichever occurs first) , this does is given in accordance with Australian Research Centre for Health of Women and Babies, 2010, for using MgSo4 for neuroprotection against CP.

While 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 (Hösli et.al, 2014).

The ability of the MgSo4 as a neuro protectant is dependent on its cerebral vasodilating effects (Magee et.al,2011; Macdonald et.al, 2004), therefore we propose 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. All ultrasound and power doppler examinations will be carried out by the same investigator, using the Voluson 730 machine (GE Healthcare Austria GmbH, Seoul, Korea). Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd., Cheshire, UK.

Being tested
Magesium sulphate, Nifedipine, Doppler on fetal middle cerebral artery
Keywords
Neuroprotection, calcium channel blockers, magnesium sulhate, Middle cerebral artery doppler
Medical subject headings
Obstetric Labor, Premature, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magesium sulphateDrug

    Also called MgSo4

    *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)

  • NifedipineDrug

    Also called Epilat

    *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

  • 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.

Study groups in NCT02591004
Study groupRoleWhat they receive
Magesium sulphateExperimental* 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
Receives: Drug: Magesium sulphate; Radiation: Doppler on fetal middle cerebral artery
NifedipineActive 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
Receives: Drug: Nifedipine; Radiation: Doppler on fetal middle cerebral artery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionOct 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02591004
Sponsor's protocol ID
A21102015
Status last verified
Nov 2017
First submitted
26 Oct 2015
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21639972

  • 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.

    PubMed 24385286

  • 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/].

  • 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.

    PubMed 14743919

  • 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.

    PubMed 9457123

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Magesium sulphate, Nifedipine and Doppler on fetal middle cerebral artery in people with Preterm Labor and Cerebral Palsy, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

difference in mean doppler indicies of middle cerebral artery of fetus between both groups (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02591004, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

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